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First Enrollment for Moderately-to-Severely Active Ulcerative Colitis

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Adiso Therapeutics, Inc. today announced that it has completed enrollment of its first cohort of patients in a Phase 1b clinical study evaluating ADS051 (BT051), an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation, as a potential treatment for patients with moderately-to-severely active ulcerative colitis (UC). Blinded data indicated that dosing in this cohort was safe and well-tolerated, supporting initiation of enrollment of the second higher dose cohort. 

This Phase 1b is a randomized, double-blind, placebo-controlled, multiple ascending dose study in patients with moderately-to-severely active UC (NCT05084261). The primary objectives of this study are safety and tolerability with a secondary objective of pharmacokinetics, and exploratory objectives of reduction of neutrophil-associated biomarkers. This Phase 1b study follows a Phase 1a single ascending dose study in healthy volunteers that demonstrated ADS051 is gut-restricted with no dose-limiting toxicities or serious adverse events.

“Targeting neutrophils is a novel strategy for treating the underlying pathophysiology of ulcerative colitis. This Phase 1b study is the next step in exploring how ADS051 may safely and effectively inhibit key pathways known to cause the migration and activation of neutrophils in the colon where the acute inflammatory process in UC is ongoing. In this study we will look for biomarkers of pharmacological activity and early signs of clinical activity that may translate into reductions in colonic inflammation and promote mucosal healing in patients with moderate-to-severe UC,” said Scott Megaffin, Chief Executive Officer, Adiso. “Continuing to advance the clinical development of ADS051 is important given the significant unmet need for patients with UC who have few available gut-restricted therapies unique to neutrophil trafficking.”

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