Cristcot's Phase 3 Trial of Hydrocortisone Acetate Suppository Meets Endpoints for Ulcerative Colitis

Cristcot, a pharmaceutical company focused on gastrointestinal diseases, has announced positive topline results from its Phase 3 clinical trial evaluating a novel hydrocortisone acetate (HCA) suppository for the treatment of ulcerative colitis (UC) of the rectum. The trial, known as cessa, met both its primary and secondary endpoints, demonstrating clinical remission and rapid symptom relief in patients with moderate to severe active UC.

The Phase 3 trial randomized 171 patients experiencing moderate to severe active UC of the rectum across multiple global sites. Participants received either once-daily (QD), twice-daily (BID) dosing of the 90 mg HCA suppository, or placebo for 28 days, followed by a 10-day taper period. The primary endpoint was clinical remission by Day 29, defined as a Modified Mayo Score of 0-2, encompassing a rectal bleeding sub-score of 0, reduced stool frequency from baseline (sub-scores of 0 or 1), and mucosal healing (endoscopic sub-score of 0 or 1).

Key Findings from the cessa Trial

The results showed that 23.0% of patients in the once-daily treatment arm achieved clinical remission by Day 29, while 17.5% of patients in the twice-daily arm achieved remission. When both active treatment arms were pooled, 20.2% of patients receiving HCA reached clinical remission, compared to only 2.1% in the placebo group, demonstrating a statistically significant benefit.

The trial also met its secondary endpoint, with rapid clinical response observed in both active treatment arms by Day 15, indicated by rectal bleeding scores of 0 and reduced stool frequency scores of 0 or 1.

Safety and Tolerability

The HCA suppository was well-tolerated, with no statistically significant adverse events reported across treatment arms. Observed side effects were generally mild and consistent with those typically associated with corticosteroid use. Patient compliance was notably high, with 97% compliance reported for the once-daily regimen.

Addressing Unmet Needs in UC Treatment

Jennifer Davagian, Founder and CEO of Cristcot, emphasized the need for new therapeutic options to manage acute UC flares, noting that current therapies often take months to induce clinical response. "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," Davagian stated.

Dr. Monika Fischer, Chief Fellow in the Division of Gastroenterology and Hepatology at Indiana University Department of Medicine, added that the therapy is positioned to fill a critical gap in the treatment of ulcerative colitis and possibly related conditions. "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," said Dr. Fischer.

Mechanism of Action and Future Plans

Cristcot's HCA suppository is administered using the Sephure suppository applicator, designed to ensure precise placement, minimize discomfort and leakage, and enhance patient compliance. The company plans to finalize its New Drug Application (NDA) submission to the FDA in the first quarter of 2025 and is evaluating marketing partnerships to accelerate the drug's commercialization.

Ulcerative Colitis: A Chronic Inflammatory Condition

Ulcerative colitis is a chronic autoimmune disease characterized by inflammation and ulcers in the lining of the large intestine, affecting the rectum and sometimes the entire colon. Symptoms include rectal bleeding, diarrhea, bowel urgency, and abdominal pain, significantly impacting patients' quality of life. There is currently no cure for UC, and many patients experience frequent flares despite maintenance medication.