Adiso Therapeutics has completed a Phase Ib multiple ascending dose (MAD) trial of ADS051 (BT051) for the treatment of moderate-to-severe ulcerative colitis.
The placebo-controlled, randomised, double-blind study enrolled 24 patients with UC who completed treatment over a 28-day period.
Patients received daily oral doses of 200mg, 800mg, and 3200mg ADS051, which was found to be safe and well-tolerated in all three dosing cohorts.
Harvard Medical School associate professor of medicine and Crohn’s and Colitis Center, Brigham & Women’s Hospital Boston medical director Jessica Allegretti said: “In this Phase Ib 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.
“Continued clinical development of ADS051 as a potential therapeutic with a differentiated mechanism of action is important, given the significant unmet need for patients.”
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The MAD study followed a Phase Ia single ascending dose study in healthy subjects, which demonstrated that ADS051 was gut-restricted, with no serious adverse events or dose-limiting toxicities.
With the combined Phase Ia/Ib data, the company is planning to submit an End of Phase I meeting request to the US Food and Drug Administration, as it intends to initiate a Phase II clinical trial late this year.
ADS051 is an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation that addresses neutrophil-mediated tissue damage.