Cristcot Reports Successful Phase 3 Results for New Hydrocortisone Suppository for Rectal Ulcerative Colitis

Cristcot, a pharmaceutical company focusing on innovative treatments for gastrointestinal conditions, recently shared promising results from its pivotal Phase 3 cessa clinical trial. This study evaluated the efficacy and safety of a hydrocortisone acetate (HCA) suppository administered with the Sephure® applicator for patients suffering from ulcerative colitis (UC) of the rectum.

The purpose of the cessa Phase 3 trial was to assess Cristcot's HCA suppository formulation aimed at arresting acute UC flares. The study investigated the suppository as both a standalone treatment and in combination with other maintenance therapies, including 5-ASAs, biologics, anti-TNFs, and Jak inhibitors.

A total of 171 participants were randomized into the study, which took place at various global research centers. Participants were experiencing moderate to severe active UC of the rectum at enrollment. They received either a once-daily or twice-daily dosage of the 90 mg hydrocortisone acetate suppository, or a placebo, for 28 days, followed by a 10-day taper period.

The study's primary endpoint was achieving clinical remission by Day 29, defined by a Modified Mayo Score of 0-2, including zero rectal bleeding and reduced stool frequency, with mucosal healing verified through endoscopy. Results showed that 23.0% of patients in the once-daily group and 17.5% in the twice-daily group achieved clinical remission by Day 29. Overall, 20.2% of patients receiving active treatment reached clinical remission, significantly higher than the 2.1% in the placebo group.

Secondary endpoints assessed clinical response by Day 15, focusing on rectal bleeding and stool frequency reduction. Both active treatment groups showed rapid response by Day 15. The safety profile was favorable, with no statistically significant adverse events across treatment groups, and side effects were mild and consistent with corticosteroid use. The trial also reported high patient compliance, with 97% adherence in the once-daily group.

Jennifer Davagian, Cristcot's CEO, highlighted the urgent need for effective treatment options for UC patients, who often face long waits for current therapies to induce clinical response or remission. Cristcot aims to finalize its New Drug Application (NDA) submission in the first quarter of 2025, while also exploring marketing partnerships to expedite the drug's commercialization in the U.S. market.

Dr. Monika Fischer, affiliated with Indiana University, emphasized the significance of achieving symptom relief in as little as two weeks and clinical remission in four weeks, noting the potential of this novel therapy to meet a critical need in UC treatment. The innovative topical steroid therapy could allow for better management of acute episodes and facilitate transitions between maintenance therapies.

The cessa trial was a pivotal Phase 3 study evaluating the hydrocortisone acetate 90 mg suppository for patients with UC of the rectum. It was designed as a randomized, double-blind, placebo-controlled trial involving male and non-pregnant, non-lactating female subjects aged 18 and older. The trial demonstrated significant results for its primary and secondary endpoints, showcasing the potential of Cristcot's therapy to transform flare management in ulcerative colitis.

Cristcot's unique HCA suppository is delivered using the Sephure® applicator, ensuring precise placement and minimizing discomfort. This novel delivery method may improve patient compliance and offers rapid metabolism and localized efficacy, reducing systemic exposure compared to traditional corticosteroid treatments.

Ulcerative colitis is a chronic autoimmune condition that causes inflammation and ulcers in the large intestine, severely impacting patients' quality of life. Despite existing therapies, many patients experience frequent flares and change treatments to manage increased disease activity. Cristcot's investigational therapy addresses the need for rapid symptom relief and effective flare management.

Cristcot, headquartered in Austin, Texas, is committed to advancing targeted therapies for gastrointestinal diseases. Its lead asset, a novel hydrocortisone acetate suppository, is poised to become a first-line therapy for ulcerative colitis. The company continues to explore innovative solutions for various inflammatory gastrointestinal conditions.