Adiso Therapeutics, Inc., a US-based clinical-stage biotechnology company, announced on Wednesday that it has completed a Phase 1b multiple ascending dose (MAD) clinical trial assessing ADS051 (BT051) an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation.

The randomised double-blind placebo-controlled study enrolled 24 moderately-to-severely active ulcerative colitis (UC) patients, all of whom completed the trial as planned over the 28-day treatment period. The company said that ADS051 was found to be safe and well-tolerated with each daily oral dose in all 3 dosing cohorts (200mg, 800mg and 3200mg).

This MAD clinical trial followed a healthy subject Phase 1a single ascending dose (SAD) study which demonstrated ADS051 was gut-restricted with no dose-limiting toxicities or serious adverse events. The combined Phase 1a/1b data packages have enabled Adiso to submit an End of Phase 1 meeting request to the Food and Drug Administration FDA, as the company intends to pursue a Phase 2 development program in late 2023.

Jessica Allegretti, MD, MPH medical director, Crohn's and Colitis Center, Brigham a & Women's Hospital Boston and associate professor of medicine, Harvard Medical School, said, 'In this Phase 1b study in addition to safety, we evaluated measures of efficacy in patients with moderate to severe UC. ADS051 showed positive signals of pharmacologic activity and great promise to provide incremental benefit to patients beyond what is achieved with current therapies. Neutrophils are a hallmark of UC, and today's therapies do not directly modulate neutrophil trafficking. Continued clinical development of ADS051 as a potential therapeutic with a differentiated mechanism of action is important given the significant unmet need for patients.'