Study demonstrated promising results; planning underway to initiate Phase 2 trial in 2H 2023
CONCORD, Mass., May 31, 2023 /PRNewswire/ — Adiso Therapeutics, Inc., a clinical-stage biotechnology company developing novel medicines targeting chronic inflammatory diseases today announced the completion of a Phase 1b multiple ascending dose (MAD) clinical trial evaluating ADS051 (BT051) an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation. The randomized 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. ADS051 was found to be safe and well-tolerated with each daily oral dose in all 3 dosing cohorts (200mg, 800mg and 3200mg).
“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,” commented Jessica Allegretti, M.D., M.P.H Medical Director, Crohn’s and Colitis Center, Brigham a & Women’s Hospital Boston and Associate Professor of Medicine, Harvard Medical School. “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.”
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, as the Company intends to pursue a Phase 2 development program in late 2023.
“Adiso is enormously grateful to the patients, healthy subjects, families, healthcare professionals, hospitals and clinics that participate in clinical trials for evaluating our potential therapeutics. ADS051 represents a highly differentiated approach to the treatment of UC, Adiso looks forward to the sharing of full results at an upcoming major medical conference,” shared Scott Megaffin, Chief Executive Officer.
About ADS051
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, and in a Phase 1b MAD study, ADS051 was safe and well-tolerated and largely restricted to the gut with limited systemic exposure.
About Adiso:
Adiso Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients and their families by creating novel and differentiated medicines to treat inflammatory diseases. The company’s lead programs exemplify ‘healthruption’ (disruption in healthcare and drug development) with novel mechanisms of action and a distinct approach to precision treatment of inflammatory diseases. ADS051 is an oral, gut-restricted modulator of neutrophil trafficking and activation for the treatment of ulcerative colitis that has just completed a Phase 1b MAD clinical trial and will be moving into Phase 2 development later this year. Adiso is also developing ADS032, a novel small molecule that acts as a dual inflammasome inhibitor (NLRP3 & NLRP1) and is in advanced pre-clinical development for the treatment of respiratory and dermal inflammation. For more information, please visit www.adisotx.com or our LinkedIn page.
Contacts
Argot Partners
Media: Sarah Sutton/Liza Sullivan
IR: Jason Finkelstein
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212.600.1902
Adiso Therapeutics, Inc.
Jennifer Locke, Chief Operating & Business Officer
[email protected]
978.202.4335
SOURCE Adiso Therapeutics
