CESSA Phase 3 Clinical Trial Results Earn ACG Presidential Poster Distinction Among Nearly 6,000 Abstracts

Next-generation Hydrocortisone Acetate (ngHCA™) Suppository Administered with Sephure® Suppository Applicator Demonstrates Statistically Significant Rates of Clinical Remission in Patients with UC in CESSA Phase 3 Trial

Additional Findings Reinforce Rapid and Sustained Drug Release of ngHCA

AUSTIN, Texas, Oct. 26, 2025 /PRNewswire/ -- Cristcot, a clinical-stage pharmaceutical company advancing targeted therapies for gastrointestinal diseases, today announced that the Company is presenting three posters highlighting pivotal new data in ulcerative colitis (UC) of the rectum research at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting in Phoenix, Arizona. 

"We are excited to present Cristcot's data at ACG 2025, which showcases our meaningful contributions across the spectrum of UC research and reinforces the transformative potential of our ngHCA suppository - the first investigational agent to show rapid clinical remission in UC," said Jennifer J. Davagian, Founder and Chief Executive Officer, Cristcot. "As we progress towards FDA submission and commercialization of our novel therapy, we are focused on close collaboration with the gastroenterology community through forums like ACG to ensure we are best positioned to address the needs of patients, providers, and payers in this field. We look forward to continuing to advance our innovative, patient-centric solutions."

ACG Presidential Poster Distinction Recognizes Excellence in Clinical Research

The CESSA abstract was selected as an ACG 2025 Presidential Poster Recipient among nearly 6,000 abstracts. The distinction is reserved for approximately five percent of submissions and recognizes high-quality, novel, and clinically meaningful research contributing to advances in gastroenterology.

Pivotal Phase 3 CESSA Trial

Poster Title: Efficacy and Safety of a Novel Investigational Hydrocortisone Acetate Suppository Formulation and Optimized Applicator for Treatment of Active Ulcerative Colitis: Results of the Phase 3 CESSA Trial
Key Findings: The Phase 3 CESSA trial evaluated efficacy and safety of Cristcot's ngHCA 90 mg suppository administered with the proprietary Sephure® suppository applicator in adults with confirmed active moderate to severe UC.

Efficacy

• The trial achieved its primary endpoint of clinical remission at Day 29 and secondary endpoint of clinical response at Day 15, both using modified Mayo Score (MMS) criteria, demonstrating statistically significant improvements for patients treated with the ngHCA 90 mg suppository compared to those who received placebo.

  • Clinical and endoscopic remission was achieved by 21.2% (p=0.0005) of study participants in the ngHCA QD (once-daily) arm versus 1.5% of patients in the placebo arm.

  • Secondary efficacy analyses showed that treatment with ngHCA QD resulted in greater improvement in rectal bleeding and stool frequency scores at Day 15 and Day 29 versus placebo.

  • Concomitant medication for UC (stable dose) was taken by 63.5% of patients throughout the study. No non-study corticosteroids were permitted.

Safety and Compliance

• ngHCA was well tolerated.

• There were no treatment-related serious adverse events (SAEs).

• Treatment-related adverse events (TEAEs) were reported by 4.5% of patients in the QD treatment group and 7.6% in the placebo group.

• The majority of TEAEs were mild and moderate in severity.

• Compliance was very high - 100% of subjects in the ngHCA QD group had greater than 90% adherence with the required dosing.

Additional details on the CESSA trial can be found in Cristcot's January 2025 press release, available on the News page of its website.

"There is an urgent need for a fast-acting, localized, and easy-to-administer option to manage patients with active ulcerative colitis," said Raj Devarajan, MD, Global Medical Advisor, Cristcot, and presenting author. "I'm thrilled to share the pivotal CESSA trial results as a Presidential Poster at ACG, which marks a meaningful advancement in this area. The efficacy demonstrated in CESSA, notably clinical responses within two weeks and endoscopic remission by four weeks, has never been achieved in the moderate to severe UC population. Combined with a favorable tolerability profile, these data support this novel HCA combination product to treat UC exacerbations alongside maintenance therapies or as a monotherapy. I look forward to its continued evaluation as a new option for the many patients who continue to face gaps in effective management of this disease."

Innovation in Pharmacokinetics

Title: Pharmacokinetics and Relative Bioavailability of an Investigational Hydrocortisone Acetate Suppository Administered with a Novel FDA-Cleared Applicator Versus Hydrocortisone Liquid Enema
Key Findings: In this Phase 1 study, the ngHCA suppository administered using the Sephure® suppository applicator demonstrated sustained release with optimal bioavailability that is expected to provide consistent efficacy over the intended treatment period.

New Data Highlights: Clinical Trial Methodology

Title: Recent Recall as an Alternative to Daily Study Participant Diaries in Ulcerative Colitis Trials: Evidence from a Phase 3 Clinical Trial
Key Findings: This prespecified exploratory analysis from the Phase 3 CESSA trial demonstrated that participant-reported UC symptom data collected through recent (3-day) recall correlated with data collected through daily participant diaries. These findings indicate that recent recall offers a reliable, lower-burden alternative to daily diaries for collecting patient-reported outcomes in future UC trials.

Cristcot's presence at ACG 2025 underscores its commitment to advancing evidence-based, patient-focused solutions that address persistent gaps in ulcerative colitis care.

Additional information, including abstracts, can be found on the ACG 2025 Annual Meeting website.

About Cristcot's HCA 90 mg Suppository

Cristcot's investigational hydrocortisone acetate (HCA) 90 mg suppository formulation is a novel corticosteroid therapy delivering a small volume suppository using the Sephure® applicator to ensure precise placement, minimizing discomfort and leakage. Rectally administered topical treatments, including topical corticosteroids, are important treatment options (either alone or in combination with other therapies), for directing delivery to inflammation sites and limiting systemic drug exposure, though there is no FDA-approved corticosteroid suppository on the market. Unlike traditional corticosteroid treatments, Cristcot's advanced HCA formulation allows for rapid, sustained release with optimal bioavailability, consistent and localized efficacy, and very limited systemic exposure. The innovative delivery system may enhance patient compliance.

About Ulcerative Colitis

UC is a life-long, chronic gastrointestinal autoimmune disease characterized by inflammation and ulcers in the lining of the large intestine, including the rectum and sometimes, all or part of the colon. Symptoms often include rectal bleeding, profuse diarrhea, bowel urgency, tenesmus, and abdominal pain significantly impacting patients' quality of life. UC flares frequently originate in the rectum, and untreated inflammation can progress to more extensive disease, leading to hospitalization or surgery. There is no cure for UC and, breakthrough flares, even while taking maintenance medication, is a known characteristic of the disease profile. Over 55% of UC patients experience 3-5 flares annually, with many reporting debilitating effects on daily activities, work, and mental health. Despite existing treatments, patients experience intermittent flares and often change therapies as a measure to treat increased disease activity. The time of transition between one treatment to another is further complicated while waiting for the new therapy to reach full efficacy potential. Gaps remain in addressing flares quickly and effectively, highlighting the need for targeted therapies that can provide rapid symptom relief and remission.

About Cristcot

Cristcot is a clinical-stage pharmaceutical company dedicated to advancing targeted therapies for gastrointestinal diseases. The Company's lead asset, a novel hydrocortisone acetate suppository, is positioned to become an important therapeutic option for ulcerative colitis. Cristcot's diversified pipeline includes investigational development programs for ulcerative colitis, acute pancreatitis, hemorrhoid disease and other inflammatory gastrointestinal indications with an emphasis on innovative, patient-centric solutions. The company is headquartered in Austin, Texas.

For more information, please visit www.cristcot.com and connect with us on LinkedIn.

Forward-Looking Statements

Certain information set forth in this press release contains "forward-looking information", including "future-oriented financial information" and "financial outlook", under applicable securities laws (collectively referred to herein as forward-looking statements). Examples of forward-looking statements include, but are not limited to, statements regarding the (i) projected financial performance of the Company; (ii) market prospects and potential future sales for the Company products; (iii) expected development of the Company's products, business and projects; (iv) availability of competing products in the market; (v) prospects for regulatory approval of the Company's products; (vi) execution of the Company's vision and growth strategy; and (vii) availability of protections under applicable intellectual property laws.

These statements are not guarantees of future performance, and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this press release are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Contacts

Jenny Gizzi, Chief Administrative Officer
Cristcot
jenny.gizzi@cristcot.com

Tanner Kaufman / Katie Harris
FTI Consulting
tanner.kaufman@fticonsulting.com / katie.harris1@fticonsulting.com  

SOURCE Cristcot

Company Builds on Late-Stage Clinical Progress and Continues Momentum in Ulcerative Colitis

CONCORD, Mass., June 24, 2025 /PRNewswire/ -- Cristcot, a clinical-stage pharmaceutical company advancing innovative therapies for gastrointestinal diseases, participated in the 5th annual GI ReConnect meeting in Aurora, Colorado, as a Gold Sponsor. The conference convened leading gastroenterologists from academic institutions and community practices across the country to explore evolving approaches in gastroenterology (GI) care.

During the conference, Cristcot hosted a dedicated medical exchange meeting with GI thought leaders to discuss current trends in ulcerative colitis (UC) treatment and highlight progress on its pivotal, Phase 3 CESSA study for the treatment of UC.  The Company has continued to receive strong positive feedback as it advances its novel investigational hydrocortisone acetate (HCA) 90 mg suppository administered with Cristcot's proprietary Sephure® suppository applicator, towards commercial approval and launch. In the coming year, the Company plans to continue its meaningful engagement with the clinicians who are shaping the future of care and treatment for UC patients.

"We were thrilled to sponsor this year's GI ReConnect and continue to receive support from esteemed colleagues and thought leaders in gastroenterology on our efforts in addressing the needs of UC patients," said Jennifer J. Davagian, Founder and Chief Executive Officer, Cristcot. "Currently the Company is in a period of immense momentum as we work to advance our late-stage UC program and continue to foster our deep partnerships with the GI community. Events like this help ensure our mission alignment with the real world needs of patients and providers as we pursue our maturing clinical pipeline."

"The GI ReConnect forum provides a unique opportunity for thoughtful, real-time dialogue between companies developing new therapies and the physicians who ultimately bring those therapies to patients," said Raj Devarajan, MD, Global Medical Advisor, Cristcot. "Hearing firsthand from leading gastroenterologists about trends in UC care provides essential information to inform and strengthen the Company's clinical strategies and ensure we are focused on the latest developments for patients in need of new solutions."

Cristcot's participation in GI ReConnect is part of the Company's broader effort to expand its presence and partnerships within the field of gastroenterology. The Company plans to attend several additional GI-focused scientific meetings in 2025.

About Cristcot's HCA 90 mg Suppository

Cristcot's investigational HCA 90 mg suppository formulation is a novel therapy delivered using the Sephure® suppository applicator, the small-volume suppository ensures precise placement, minimizing discomfort and leakage. This innovative delivery system may enhance patient compliance. Unlike traditional corticosteroid treatments, the suppository's differentiated mechanism of action allows for rapid release and localized efficacy, reducing systemic exposure.

About Ulcerative Colitis

UC is a life-long, chronic gastrointestinal autoimmune disease characterized by inflammation and ulcers in the lining of the large intestine, including the rectum and sometimes, all or part of the colon. Symptoms often include rectal bleeding, profuse diarrhea, bowel urgency, tenesmus, and abdominal pain significantly impacting patients' quality of life. UC flares originate in the rectum, and untreated inflammation can progress to more extensive disease, leading to hospitalization or surgery. There is no cure for UC and, breakthrough flares, even while taking maintenance medication, is a known characteristic of the disease profile. Over 55% of UC patients experience 3-5 flares annually, with many reporting debilitating effects on daily activities, work, and mental health. Despite existing treatments, patients experience intermittent flares and often change therapies as a measure to treat increased disease activity. The time of transition between one treatment to another is further complicated while waiting for the new therapy to reach full efficacy potential. Gaps remain in addressing flares quickly and effectively, highlighting the need for targeted therapies that can provide rapid symptom relief and remission.

About Cristcot

Cristcot is a clinical-stage pharmaceutical company dedicated to advancing targeted therapies for gastrointestinal diseases. The Company's lead asset, a novel hydrocortisone acetate suppository, is positioned to become the first line therapy for ulcerative colitis. Cristcot's diversified pipeline includes investigational development programs for ulcerative colitis, acute pancreatitis, hemorrhoid disease and other inflammatory gastrointestinal indications with an emphasis on innovative, patient-centric solutions. The company is headquartered in Concord, Massachusetts.

For more information, please visit www.cristcot.com and connect with us on LinkedIn.

Forward-Looking Statements

Certain information set forth in this press release contains "forward-looking information", including "future-oriented financial information" and "financial outlook", under applicable securities laws (collectively referred to herein as forward-looking statements). Example of forward-looking statements include, but are not limited to, the (i) projected financial performance of the Company; (ii) market prospects and potential future sales for the Company products; (iii) expected development of the Company's products, business and projects; (iv) availability of competing products in the market; (v) prospects for regulatory approval of the Company's products; (vi) execution of the Company's vision and growth strategy; and (vii) availability of protections under applicable intellectual property laws.

These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this press release are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Contacts

Jenny Gizzi, Chief Administrative Officer
Cristcot
jenny.gizzi@cristcot.com

Tanner Kaufman / Shana Marino
FTI Consulting
tanner.kaufman@fticonsulting.com / shana.marino@fticonsulting.com

Proven and Dynamic Commercial Leader Joins to Build Commercialization Strategy and Organization

New Drug Application for Ulcerative Colitis on Track to be Filed in 2025

CONCORD, Mass., June 10, 2025 /PRNewswire/ -- Cristcot, a clinical-stage pharmaceutical company advancing innovative therapies for gastrointestinal diseases, today announced the appointment of Richard Kim to the role of Chief Commercial Officer. In this role, Mr. Kim will lead all aspects of planning and execution for commercialization upon FDA approval for the Company's lead program, a novel hydrocortisone acetate (HCA 90 mg suppository administered with Cristcot's proprietary Sephure® applicator for patients with ulcerative colitis (UC) of the rectum). This appointment follows Cristcot's recent topline results from its pivotal Phase 3 CESSA clinical trial.

Mr. Kim is a results driven and respected commercial leader with over 25 years of leadership experience in biopharmaceutical commercialization across the U.S. and global markets. He has successfully led more than a dozen product launches at both large pharmaceutical companies and emerging biotechs, with particular expertise in specialty areas including gastroenterology. He most recently served as Chief Commercial Officer at Avadel Pharmaceuticals, where he oversaw the successful launch of LUMRYZ™ and built the company's commercial function from the ground up.

"Earlier this year, we shared strong results from our pivotal Phase 3 CESSA study in UC, with subjects achieving clinical response by Day 15 and clinical remission, defined by mucosal healing, by Day 29," said Jennifer J. Davagian, Founder and Chief Executive Officer, Cristcot. "As we advance our lead asset towards commercialization, including our upcoming NDA submission this year, Richard's appointment reflects an important inflection point for our company as our focus turns to building our commercial launch capabilities. His deep experience launching innovative therapies and leading high-performing commercial organizations makes him a key addition to our team. With Richard's appointment, following Jenny Gizzi's recent appointment as Chief Administrative Officer, we are building a powerhouse leadership team to bring this therapy to patients following FDA approval and scale our organization for the future."

Mr. Kim added, "Cristcot has already delivered compelling phase 3 clinical results in a therapeutic area with significant unmet need. I'm thrilled to join at this pivotal time to shape the commercial launch strategy and build an exceptional team as we prepare to bring a highly differentiated new treatment option to people living with UC following regulatory approval."

Mr. Kim previously served as the President of U.S. Commercial & Strategic Marketing at Intercept Pharmaceuticals Inc. where he successfully launched OCALIVA™ (obeticholic acid), the first new treatment in nearly 20 years for Primary Biliary Cholangitis. He also worked at Bristol-Myers Squibb as the General Manager of Worldwide Commercialization where he led the impressive worldwide launch of DAKLINZA™ (daclatasvir) for hepatitis C. He also held other roles including leading large sales teams, U.S. oncology marketing and strategic marketing. Mr. Kim started his biopharmaceutical career at Schering-Plough, which was acquired by Merck & Co., Inc. and held a range of senior positions in the U.S., Canada and Australia. Mr. Kim received his B.S. in Chemistry from the University of Alberta.

About Cristcot's HCA 90 mg Suppository 
Cristcot's investigational HCA 90 mg suppository formulation is a novel therapy delivered using the Sephure® suppository applicator, the small-volume suppository ensures precise placement, minimizing discomfort and leakage. This innovative delivery system may enhance patient compliance. Unlike traditional corticosteroid treatments, the suppository's differentiated mechanism of action allows for rapid release and localized efficacy, reducing systemic exposure.

In January 2025, the Company announced positive Phase 3 data from its pivotal CESSA trial, which met its primary and secondary endpoints, achieving a clinical response by Day 15 and clinical remission by Day 29 in patients with ulcerative colitis (UC) of the rectum.

About Ulcerative Colitis
UC is a life-long, chronic gastrointestinal autoimmune disease characterized by inflammation and ulcers in the lining of the large intestine, including the rectum and sometimes, all or part of the colon. Symptoms often include rectal bleeding, profuse diarrhea, bowel urgency, tenesmus, and abdominal pain significantly impacting patients' quality of life. UC flares originate in the rectum, and untreated inflammation can progress to more extensive disease, leading to hospitalization or surgery. There is no cure for UC and, breakthrough flares, even while taking maintenance medication, is a known characteristic of the disease profile. Over 55% of UC patients experience 3-5 flares annually, with many reporting debilitating effects on daily activities, work, and mental health. Despite existing treatments, patients experience intermittent flares and often change therapies as a measure to treat increased disease activity. The time of transition between one treatment to another is further complicated while waiting for the new therapy to reach full efficacy potential. Gaps remain in addressing flares quickly and effectively, highlighting the need for targeted therapies that can provide rapid symptom relief and remission.

About Cristcot 
Cristcot is a clinical-stage pharmaceutical company dedicated to advancing targeted therapies for gastrointestinal diseases. The Company's lead asset, a novel hydrocortisone acetate suppository, is positioned to become the first line therapy for ulcerative colitis. Cristcot's diversified pipeline includes investigational development programs for ulcerative colitis, acute pancreatitis, hemorrhoid disease and other inflammatory gastrointestinal indications with an emphasis on innovative, patient-centric solutions. The company is headquartered in Concord, Massachusetts.

For more information, please visit www.cristcot.com and connect with us on LinkedIn.

Forward-Looking Statements
Certain information set forth in this press release contains "forward-looking information", including "future-oriented financial information" and "financial outlook", under applicable securities laws (collectively referred to herein as forward-looking statements). Example of forward-looking statements include, but are not limited to, the (i) projected financial performance of the Company; (ii) market prospects and potential future sales for the Company products; (iii) expected development of the Company's products, business and projects; (iv) availability of competing products in the market; (v) prospects for regulatory approval of the Company's products; (vi) execution of the Company's vision and growth strategy; and (vii) availability of protections under applicable intellectual property laws.

These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this press release are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Contacts

Jenny Gizzi, Chief Administrative Officer
Cristcot
jenny.gizzi@cristcot.com

Tanner Kaufman / Shana Marino
FTI Consulting
tanner.kaufman@fticonsulting.com / shana.marino@fticonsulting.com

Biopharma Operations Leader Brings Proven Track Record in Organizational Strategy, Talent, and Growth Enablement

CONCORD, Mass., May 19, 2025 /PRNewswire/ -- Cristcot, a clinical-stage pharmaceutical company advancing innovative therapies for gastrointestinal diseases, today announced the appointment of Jenny Gizzi as Chief Administrative Officer. In this new role, Ms. Gizzi will oversee business operations, including Information Technology (IT), Human Resources (HR), Corporate Standards and Compliance. Ms. Gizzi will focus on building scalable systems to enable cross-functional teams to support Cristcot's continued growth. Her efforts will help as the Company advances its lead therapy, a novel 90 mg hydrocortisone acetate (HCA) suppository administered with the Sephure® suppository applicator for patients with ulcerative colitis (UC) of the rectum, towards FDA regulatory submission and full-scale manufacturing and commercial preparations. This appointment follows Cristcot's recent topline results from its pivotal Phase 3 CESSA clinical trial.

Jenny brings more than 20 years of experience leading strategy, operations, talent acquisition, and infrastructure transformation across both emerging biotech and global pharmaceutical companies. Most recently, she served as Chief People Officer at Elevar Therapeutics, where she led company-wide initiatives across HR, IT, Communications, and Administration Planning in support of the company's first U.S. commercial launch preparations. Her leadership resulted in significant operational efficiencies, cost savings, and the implementation of a scalable strategy aligned to the company's mission and growth trajectory.

"We are thrilled to welcome Jenny to the Cristcot team as we continue to build on the momentum from our positive Phase 3 results. Her work will enhance the build out of our commercial business operations and scaled manufacturing capabilities as we continue to work on our other products in development," said Jennifer Davagian, Founder and CEO of Cristcot. "Jenny has a unique combination of strategic insight, operational discipline, and leadership expertise, coupled with a strong track record of guiding companies through growth and transformation. As we continue to advance our pipeline and expand our Company in preparation for commercialization, her expertise will be instrumental as we recruit accomplished individuals and implement the systems and structure needed to support both near-term execution and long-term success."

 "I am excited to be joining Cristcot at such a pivotal moment in the Company's journey, moving from clinical operations to pre-commercial planning for a successful future," added Jenny. "Cristcot has made meaningful advances in its product development and scientific research and is poised to move swiftly to build the capabilities needed to deliver on its mission to patients. I look forward to working with the leadership team to strengthen the Company's operational structure, ensure the right standards are in place and adhered to, and the infrastructure support is well established to enable sustained success."

Ms. Gizzi previously held senior roles at Arena Pharmaceuticals, Bristol-Myers Squibb, Illumina, and Mirati Therapeutics. Her career spans strategic leadership in global talent, business operations, and large-scale transformation across commercial, R&D, and enterprise functions. She holds a BA in Corporate Communications from Fairleigh Dickinson University.

About Cristcot's HCA SuppositoryCristcot's investigational HCA suppository formulation is a novel therapy delivered using the Sephure® suppository applicator, the small-volume suppository ensures precise placement, minimizing discomfort and leakage. This innovative delivery system may likely enhance patient compliance. Unlike traditional corticosteroid treatments, the suppository's differentiated mechanism of action allows for rapid release and localized efficacy, reducing systemic exposure.

In January 2025, the Company announced positive Phase 3 data from its pivotal CESSA trial, which met its primary and secondary endpoints, achieving a clinical response by Day 15 and clinical remission by Day 29 in patients with ulcerative colitis (UC) of the rectum.

About Ulcerative ColitisUC is a life-long, chronic gastrointestinal autoimmune disease characterized by inflammation and ulcers in the lining of the large intestine, including the rectum and sometimes, all or part of the colon. Symptoms often include rectal bleeding, profuse diarrhea, bowel urgency, tenesmus, and abdominal pain significantly impacting patients' quality of life. UC flares originate in the rectum, and untreated inflammation can progress to more extensive disease, leading to hospitalization or surgery. There is no cure for UC and, breakthrough flares, even while taking maintenance medication, is a known characteristic of the disease profile. Over 55% of UC patients experience 3-5 flares annually, with many reporting debilitating effects on daily activities, work, and mental health. Despite existing treatments, patients experience intermittent flares and often change therapies as a measure to treat increased disease activity. The time of transition between one treatment to another is further complicated while waiting for the new therapy to reach full efficacy potential. Gaps remain in addressing flares quickly and effectively, highlighting the need for targeted therapies that can provide rapid symptom relief and remission.

About CristcotCristcot is a clinical-stage pharmaceutical company dedicated to advancing targeted therapies for gastrointestinal diseases. The Company's lead asset, a novel hydrocortisone acetate suppository, is positioned to become the first line therapy for ulcerative colitis. Cristcot's diversified pipeline includes investigational development programs for ulcerative colitis, acute pancreatitis, hemorrhoid disease and other inflammatory gastrointestinal indications with an emphasis on innovative, patient-centric solutions. The company is headquartered in Austin, Texas.

For more information, please visit www.cristcot.com and connect with us on LinkedIn.

Forward-Looking StatementsCertain information set forth in this press release contains "forward-looking information", including "future-oriented financial information" and "financial outlook", under applicable securities laws (collectively referred to herein as forward-looking statements). Example of forward-looking statements include, but are not limited to, the (i) projected financial performance of the Company; (ii) market prospects and potential future sales for the Company products; (iii) expected development of the Company's products, business and projects; (iv) availability of competing products in the market; (v) prospects for regulatory approval of the Company's products; (vi) execution of the Company's vision and growth strategy; and (vii) availability of protections under applicable intellectual property laws.

These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this press release are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Contacts

Mark C. Ensign, COO/CSO
Cristcot
info@cristcot.com 

Tanner Kaufman / Shana Marino
FTI Consulting
tanner.kaufman@fticonsulting.com / shana.marino@fticonsulting.com

Pivotal Phase 3 Data Met Pre-defined Outcomes - Achieving a  Clinical Response by Day 15 and  Clinical Remission by Day 29

On Track for NDA Submission in Q1 2025

CONCORD, Mass., Jan. 9, 2025 /PRNewswire/ -- Cristcot, a clinical-stage pharmaceutical company advancing innovative therapies for gastrointestinal diseases, today announced positive topline results from its pivotal Phase 3 cessa clinical trial evaluating its novel hydrocortisone acetate (HCA) suppository administered with the Sephure® suppository applicator in patients with ulcerative colitis (UC) of the rectum.

The cessa Phase 3 trial was constructed to evaluate the safety and efficacy of Cristcot's investigational  HCA suppository formulation designed to halt acute flares in UC. The study examined the treatment for use alone as monotherapy or with other maintenance therapies (e.g., 5-ASAs, biologics, anti-TNFs, Jak inhibitors, etc.).

Key Phase 3 Study Results: 

The cessa Phase 3 trial randomized 171 patient subjects, meeting the study protocol criteria, who were experiencing moderate to severe active UC of the rectum at the time of enrollment. The study was conducted at multiple research sites around the world and patient subjects were randomized to receive either once-daily (QD), twice-daily (BID) dosing of the 90 mg hydrocortisone acetate suppository or placebo for 28 days, followed by a 10-day taper period.

• Primary Endpoint: Clinical Remission by Day 29 (Visit 7)

  • The trial achieved its primary endpoint of clinical remission, defined as a Modified Mayo Score of 0-2, which includes rectal bleeding sub-score of 0, reduction of stool frequency from baseline with sub-scores of 0 or 1 and mucosal healing as determined by an endoscopic sub-score of 0 or 1.

  • In the once-daily (QD) treatment arm, 23.0% of patients achieved clinical remission by Day 29.

  • In the twice-daily (BID) treatment arm, 17.5% of patients achieved clinical remission by Day 29.

  • When pooling both treatment active treatment arms, 20.2% of patients receiving active treatment reached clinical remission, compared to only 2.1% in the placebo group, demonstrating a statistically significant benefit.

• Secondary Endpoints: Clinical Response by Day 15 (Visit 5)

  • Rapid clinical response for both, rectal bleeding = 0 and reduction of stool frequency = 0 or 1, was observed in both active treatment arms by Day 15.

• Safety Profile

  • The treatment was well-tolerated, with no adverse events of statistical significance reported across treatment arms.

  • Side effects observed were generally mild and consistent with those typically associated with corticosteroid use.

• Patient Compliance

  • Notably, the trial demonstrated high compliance rates across treatment arms, with 97% compliance for the once-daily regimen.

"UC patients are urgently in need of a therapeutic  option to manage intermittent and acute flares, inherent in the disease profile, as current therapies often take several months to induce clinical response and up to 52 weeks to achieve remission," said Jennifer Davagian, Founder and Chief Executive Officer, Cristcot. "During the first quarter of 2025 we will be finalizing our NDA submission as we continue to build our manufacturing and commercial capabilities to bring this potentially transformative therapy to patients in the U.S. We are also evaluating marketing partnerships that would help accelerate the commercialization of the drug to market. We look forward to providing further updates in the coming months."

"Subject to FDA approval, the ability for patients to achieve symptomatic relief in as little as two weeks and clinical remission in just four weeks will be a significant advancement for UC patients," added Dr. Monika Fischer, MD, MSc, FACG, AGAF, Chief Fellow in the Division of Gastroenterology and Hepatology, Indiana University Department of Medicine. "This novel therapy is positioned to fill a critical gap in the treatment of ulcerative colitis and possibly related conditions. A novel topical steroid therapy can allow physicians to better manage acute crisis episodes and/or transition patients from one maintenance therapy to another, while reducing the burden to both patients and payers. These results demonstrate Cristcot's potential to transform how we approach flare management and change the treatment paradigm for ulcerative colitis. Cristcot's new product is a potential new best-in-class therapy that delivers better efficacy through its unique release and absorption profile."

About the cessa Trial This pivotal Phase 3 trial was designed to evaluate the safety and efficacy of Cristcot's hydrocortisone acetate 90-milligram suppository in patients with ulcerative colitis of the rectum. This was a randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years and older. Conducted across multiple global sites, the trial enrolled 784 patient subjects with 171 meeting the criteria of the protocol who received twice-daily dosing of the suppository for 28 days, followed by a 10-day taper period. The study's primary endpoint was clinical remission at Day 29, defined by a Modified Mayo score of 0-2 including zero bleeding, reduction of stool frequency and mucosal healing. Secondary endpoints included rapid symptom relief, with significant clinical response of a reduction in both bleeding and stool frequency observed as early as Day 15.

Baseline Characteristics:

• Male or non-pregnant, non-lactating females aged 18 years and older.

• Subjects with a confirmed diagnosis of UC with an endoscopic score 2-3 extending no further than 15 centimeters (cm) from the anal verge as assessed by endoscopic procedure performed at Visit 2.

  • Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have an endoscopic score of 2-3 only in the rectum at the time of the screening endoscopy (endoscopic score 0-1 beyond 15 cm from the anal verge is not exclusionary).

• Modified Mayo sub-score for stool frequency of 1-3.

• Modified Mayo sub-score for rectal bleeding of 0-2.

• Modified Mayo endoscopic sub-score of 2-3.

• Total Modified Mayo Score (without physician global assessment) of 4-8.

About Cristcot's HCA Suppository Cristcot's investigational HCA suppository formulation is a novel therapy delivered using the Sephure® suppository applicator, the small-volume suppository ensures precise placement, minimizing discomfort and leakage. This innovative delivery system may likely enhance patient compliance. Unlike traditional corticosteroid treatments, the suppository's differentiated mechanism of action allows for rapid metabolism and localized efficacy, reducing systemic exposure.

About Ulcerative ColitisUC is a life-long, chronic gastrointestinal autoimmune disease characterized by inflammation and ulcers in the lining of the large intestine, including the rectum and sometimes, all or part of the colon. Symptoms often include rectal bleeding, profuse diarrhea, bowel urgency, tenesmus, and abdominal pain significantly impacting patients' quality of life. UC flares originate in the rectum, and untreated inflammation can progress to more extensive disease, leading to hospitalization or surgery. There is no cure for UC and breakthrough flares, even while taking maintenance medication, is a known characteristic of the disease profile. Over 55% of UC patients experience 3-5 flares annually, with many reporting debilitating effects on daily activities, work, and mental health. Despite existing treatments, patients experience intermittent flares and often change therapies as a measure to treat increased disease activity. The time of transition between one treatment to another is further complicated while waiting for the new therapy to reach full efficacy potential. Gaps remain in addressing flares quickly and effectively, highlighting the need for targeted therapies that can provide rapid symptom relief and remission.

About Cristcot Cristcot is a clinical-stage pharmaceutical company dedicated to advancing targeted therapies for gastrointestinal diseases. The Company's lead asset, a novel hydrocortisone acetate suppository, is positioned to become the first line therapy for  ulcerative colitis. . Cristcot's diversified pipeline includes investigational development programs for ulcerative colitis, acute pancreatitis, hemorrhoid disease and other inflammatory gastrointestinal indications with an emphasis on innovative, patient-centric solutions. The company is headquartered in Austin, Texas.

For more information, please visit www.cristcot.com and connect with us Linkedin.

Forward-Looking StatementsCertain information set forth in this press release contains "forward-looking information", including "future-oriented financial information" and "financial outlook", under applicable securities laws (collectively referred to herein as forward-looking statements). Example of forward-looking statements include, but are not limited to, the (i) projected financial performance of the Company; (ii) market prospects and potential future sales for the Company products; (iii) expected development of the Company's products, business and projects; (iv) availability of competing products in the market; (v) prospects for regulatory approval of the Company's products; (vi) execution of the Company's vision and growth strategy; and (vii) availability of protections under applicable intellectual property laws.

These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this press release are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Contacts

Mark C. Ensign, COO/CSO
info@cristcot.com

Tanner Kaufman / Shana Marino
FTI Consulting

tanner.kaufman@fticonsulting.com / shana.marino@fticonsulting.com