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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
[email protected]

Tanner Kaufman / Katie Harris
FTI Consulting
[email protected] / [email protected]  

SOURCE Cristcot