Adiso Therapeutics Announces Data Publication of Two Phase 1 Studies of First-in-Class Neutrophil Modulator ADS051 in the American Journal of Gastroenterology

ADS051 is the first and only MRP2 / FPR1 inhibitor to demonstrate favorable safety and tolerability with signals of clinical efficacy with relief from disruptive symptoms of inflammatory bowel disease in a multiple ascending dose (MAD) study of moderately to severely active Ulcerative Colitis (UC) patients in relapse

ADS051 was demonstrated to be safe in a single ascending dose (SAD) study in healthy volunteers across five dosing cohorts

Excerpt from the Press Release:

CONCORD, Mass., March 6, 2025 /PRNewswire/ — Adiso Therapeutics, Inc. announced the publication of the results of two Phase 1 studies, which showed that healthy subjects and ulcerative colitis (UC) patients given oral doses of ADS051, a novel modulator of neutrophils being developed for Inflammatory Bowel Disease (IBD), could be safely administered and well-tolerated in IBD patients.  These studies showed consistent safety and tolerability of ADS051 with highly encouraging signals of clinical response as determined by Mayo Endoscopic Scoring blinded to the investigator.  Data from the two trials has been published in the American Journal of Gastroenterology, the official journal of the American College of Gastroenterology (ACG). 

The first of the two publications presents the results from the single ascending dose (SAD) trial of ADS051.  This trial was the intensive first in human study of ADS051 across five (5) dosing cohorts of healthy subjects and included a deep-reaching pharmacokinetic analysis of this first and only modulator of neutrophils.  There were no dose-limiting toxicities, serious adverse events (AEs), or trial discontinuation due to AEs. Pharmacokinetic data demonstrated minimal systemic absorption of ADS051, with the majority of drug excreted in the stool as expected. There was no clinical evidence of adverse immunosuppressive activity.

The second publication presents the results of a multiple ascending dose (MAD) study of ADS051 in patients with moderately to severely active UC. The MAD study included three (3) placebo controlled dosing cohorts, measuring signals of clinical response using assessments typical for later stage studies, such as Mayo Endoscopic Scoring which included Clinical Remission (CR), Endoscopic Improvement (EI), and Endoscopic Response (ER). The study also looked at neutrophil-related markers of inflammation and histologic assessment.  As detailed in the publication, this study achieved its primary endpoint of safety and tolerability with encouraging signs of efficacy across multiple outcome measures.

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