Endoscopic Remission in the Treatment of Ulcerative Colitis

As summarized in a press release, Brilacidin, in patients with ulcerative proctitis/ulcerative proctosigmoiditis (UP/UPS), is showing signs of inducing endoscopic response—a key endpoint identified by the Food and Drug Administration (FDA) when developing therapies for treating Ulcerative Colitis (UC).

Preliminary review of images and video, in the first cohort of patients (those who had been treated with Brilacidin at 50 mg daily by retention enema), showed meaningful improvements for 5 of 6 patients, including noticeable reductions in ulceration and bleeding.

In 2016 draft guidance for UC, the FDA conveyed the “ideal primary efficacy assessment tool” would include an “endoscopic and histological assessment scale,” in addition to a “patient-reported outcome instrument.” This guidance reinforces the importance of endoscopic remission as a critical efficacy measure toward gaining drug approval. 

That Brilacidin is showing signs of mucosal healing, as well as having a favorable pharmacokinetic profile (low systemic absorption), speaks to its potential as a novel treatment for various types of Inflammatory Bowel Disease (IBD).

Innovation looks forward to continuing to share data from the ongoing Proof-of-Concept trial evaluating Brilacidin in treating UC, with complete topline results anticipated to be available in 2H2017.

Source: http://www.fda.gov/downloads/Drugs/Guidances/UCM515143.pdf

Source: http://www.fda.gov/downloads/Drugs/Guidances/UCM515143.pdf