#USA #Austin #Ulcerative Colitis #Cristcot #HCA Therapy

Cristcot Presents Groundbreaking Ulcerative Colitis Treatment Data at ACG 2025

In an exciting development for ulcerative colitis (UC) research, Cristcot, a clinical-stage pharmaceutical company based in Austin, Texas, has announced that it will present three groundbreaking posters highlighting pivotal data on its novel hydrocortisone acetate (ngHCA™) therapy at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting in Phoenix, Arizona. This prestigious event will bring together experts from across the globe to discuss advances in the field of gastroenterology.

Key Findings from the CESSA Phase 3 Clinical Trial

The CESSA trial results, which have garnered the ACG Presidential Poster distinction, indicate that patients treated with the ngHCA 90 mg suppository display significant improvements in clinical remission rates compared to those receiving placebo. Specifically, clinical remission was achieved by 21.2% of participants in the ngHCA treatment group at Day 29, marking a striking contrast to only 1.5% in the placebo group. This notable finding demonstrates the potential of the ngHCA therapy as a transformative option for patients suffering from moderate to severe UC.

Jennifer J. Davagian, the Founder and CEO of Cristcot, expressed her excitement, stating, "The data we present at ACG 2025 illustrates our vital contributions to UC research and highlights the promising prospects of our ngHCA suppository, which aims to facilitate rapid clinical remission." The high interest in these findings should further motivate collaboration with healthcare providers to tailor treatment strategies that effectively address patient needs.

Trial Design and Results

The Phase 3 CESSA trial specifically evaluated the efficacy and safety of the ngHCA 90 mg suppository administered with the patented Sephure® applicator. This innovative device ensures precise placement and minimizes patient discomfort. The trial's secondary endpoints further emphasized the treatment's benefits, showing significant improvements in rectal bleeding and stool frequency at both Day 15 and Day 29 when compared to the placebo group.

Moreover, the participant compliance rate was impressive, with 100% of subjects in the ngHCA group maintaining over 90% adherence to the prescribed regimen, underscoring the therapy's user-friendly design and tolerability.

A Commitment to Patient-Centric Solutions

Dr. Raj Devarajan, Global Medical Advisor at Cristcot and the presenting author, highlighted the urgent need for fast-acting and localized therapies for active UC. He noted how the CESSA trial's impressive outcomes underscore a meaningful advancement in treatment, particularly with the potential for patients to achieve clinical responses within two weeks.

Furthermore, Cristcot's innovative approach to pharmacokinetics was evidenced in its Phase 1 studies, wherein ngHCA demonstrated optimal bioavailability and sustained release when using the Sephure® applicator compared to traditional hydrocortisone liquid enema.

The Future of UC Treatment

Cristcot’s commitment extends beyond presenting data; it aims to enhance patient experience and outcomes through continued research and innovative solutions. As highlighted during the conference, there’s a critical gap in fast-responding treatment options for UC patients who often face debilitating flares despite ongoing therapies. The need for effective management options remains an overarching concern for the healthcare community.

Conclusion

Cristcot’s innovative ngHCA suppository signifies a promising horizon in the management of ulcerative colitis, symbolizing hope for many who struggle with the condition. As they prepare for FDA submission and commercialization, Cristcot is dedicated to working closely with gastroenterologists to refine and implement this novel treatment, paving the way for better patient outcomes in gastrointestinal healthcare. For further details on Cristcot's findings and innovations in ulcerative colitis treatment, visit their website or connect with them on LinkedIn.