CONCORD, Mass., Jan. 9, 2025
Pivotal Phase 3 Data Met Pre-defined Outcomes - Achieving a Clinical Response by Day 15 and Clinical Remission by Day 29
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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 SephureŽ suppository applicator in patients with ulcerative colitis (UC) of the rectum.
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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.
"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:
About Cristcot's HCA Suppository Cristcot's investigational HCA suppository formulation is a novel therapy delivered using the SephureŽ 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.
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Contacts
Mark C. Ensign, COO/[email protected]
Tanner Kaufman / Shana MarinoFTI [email protected] / [email protected]
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