The trial met both its secondary and primary endpoints in driving disease remission and stopping rectal bleeding. Credit: Shutterstock / Doucefleur

Massachusetts gastrointestinal disease firm, Cristcot, has announced results from its Phase III trial examining its hydrocortisone suppository and applicator for ulcerative colitis (UC), finding it to drive remissions and halt rectal bleeding.

Topline results from the company’s Phase III trial (NCT04469686) found that the company’s hydrocortisone acetate (HCA) suppository, administered using its proprietary Sephur suppository applicator, met its primary endpoints of clinical remission as measured through a modified version of the Mayo Score for UC.

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The primary endpoint called for patients to meet an average score between 0 and 2 on the Mayo score, with 0 representing an unaffected person. In the trial, 171 patients were split into three arms with one receiving either once-daily or twice-daily dosing of the 90mg hydrocortisone acetate suppository, or placebo for 28 days. Results from the trial saw 23.0% of patients in the single dose arm achieving clinical remission by day 29. In the twice-daily treatment arm, 17.5% of patients achieved clinical remission. In the placebo group, only 2.1% of patients saw remission.

Additionally, the trial met its secondary endpoint by cutting the score for rectal bleeding down to an average of 0 across all groups by day 15, alongside similar results in the reduction of stool frequencies.

Now, the company is looking to parse its success into a New Drug Application (NDA) before the US Food and Drug Administration (FDA).

Jennifer Davagian, founder and chief executive officer for Cristcot, said: “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.

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“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.”

Elsewhere in the UC market, Hong Kong-based Insilico Medicine has announced positive results from two Phase I studies of the company’s artificial intelligence-designed treatment ISM5411 (NCT06012578). Meanwhile, Utah biopharma company Sorriso Pharmaceuticals has confirmed its Phase Ib trial of an oral drug met its endpoints, as the company prepares for the next phase.