Adiso Therapeutics Announces Completion of First Cohort Enrollment in a Phase 1b Study of ADS051 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis
- Category: Small Molecules
- Published on Wednesday, 13 April 2022 17:25
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CONCORD, MA, USA I April 13, 2022 I Adiso Therapeutics, Inc., a clinical-stage biotechnology company developing novel medicines targeting chronic inflammatory diseases, 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."
ADS051 is an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation for the treatment of moderate-to-severe ulcerative colitis. Unlike currently available therapies, it addresses neutrophil-mediated tissue damage, a hallmark of UC pathology. In a healthy volunteer SAD study, ADS051 was safe and well-tolerated and largely restricted to the gut with limited systemic exposure. It is currently being evaluated in a Phase 1b MAD study in moderate-to-severe ulcerative colitis.
Adiso is a clinical-stage biopharmaceutical company dedicated to improving the health of patients suffering from debilitating inflammatory diseases. This dedication is epitomized by our lead clinical candidates, ADS024, an oral single strain live biotherapeutic product (SS-LBP) mild-to-moderate ulcerative colitis and prevention of C. difficile recurrence; ADS051, an oral, gut-restricted modulator of neutrophil trafficking and activation for the treatment of moderate-to-severe ulcerative colitis; and ADS032, a dual NLRP3/NLRP1 inflammasome inhibitor initially being developed for inflammatory diseases of the lung. Adiso has built these development programs upon a rich history of institutional and academic collaboration, including the University College Cork, Ireland, the APC Microbiome Institute, the University of Massachusetts Chan Medical School, the Hudson Institute of Medical Sciences Centre for Innate Immunity and Infectious Diseases in Australia and the University of Edinburgh Centre for Inflammation Research. For more information, please visit www.adisotx.com or our LinkedIn page.
SOURCE: Adiso Therapeutics