GHENT, Belgium–(COMMERCIAL THREAD)–Agomab Therapeutics NV (“Agomab”) today announced positive clinical results from its Phase 1 study evaluating AGMB-129, an oral small molecule ALK5 kinase (TGF) inhibitor with oral gastrointestinal restrictionbetaRI or ALK5), intended for the treatment of fibrostenosing Crohn’s disease (FSCD). The study, designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of AGMB-129 in healthy subjects, demonstrated high local exposure to AGMB-129 in the ileum and no clinically relevant systemic exposures.
The Phase 1 study included single ascending dose (SAD), multiple ascending dose (MAD), and food effect (FE) phases, as well as an additional phase to assess local drug exposure in the ileal mucosa, where fibrostenotic strictures in the FSCD patients are most often located. A total of 81 healthy subjects were randomized to receive single or multiple daily oral doses of AGMB-129 or matching placebo.
AGMB-129 was well tolerated at all doses tested. The incidence and intensity of adverse events were similar across all dose cohorts, including the placebo cohort. No drug-related safety signals or dose-limiting toxicities were identified. The favorable safety profile from the Phase 1 study supports the evaluation of AGMB-129 in a planned global Phase 2a study in patients with FSCD. Plasma PK analyzes showed no clinically relevant systemic exposure, while ileal biopsies showed high local concentrations of AGMB-129, confirming that the gastrointestinal restriction mechanism can function efficiently in humans.
“The positive results from this Phase 1 study are an important first step in our clinical development of AGMB-129 and confirm its tolerability and gastrointestinal restriction mechanism” said Philippe Wiesel, Chief Medical Officer of Agomab Therapeutics. “We look forward to advancing AGMB-129 into a global Phase 2a study in patients with fibrostenogenic Crohn’s disease, a disease for which there are currently no medicines available.”
AGMB-129 is an oral GI small molecule inhibitor of ALK-5 (or TGFbetaR1) for the treatment of fibrostenosing Crohn’s disease (FSCD). TGFbeta it is a known master regulator of fibrosis and preliminary clinical data support pathway targeting in fibrotic indications. AGMB-129 is specifically designed to inhibit ALK5 in the gastrointestinal tract. Rapid first-pass metabolism in the liver prevents clinically relevant systemic exposure, offering a better safety profile than other inhibitors in its class. Fibrostenotic complications occur in up to 50% of patients with Crohn’s disease and are the leading cause of bowel resection surgery. However, there are no specific therapies approved for FSCD.
Agomab is translating deep expertise in growth factor biology to pioneer and develop new treatments that aim to resolve fibrosis, repair tissue structure and restore organ function. By combining new scientific insights with robust drug development and a long-term corporate vision, we are building a broad clinical pipeline of differentiated programs with disease-modifying potential in fibrotic diseases.