Agomab Reports Positive Phase 1 Results with AGMB-129, a GI-restricted ALK5 Inhibitor for Fibrostenosing Crohn’s Disease

Agomab Therapeutics today announced positive clinical results from its Phase 1 study evaluating AGMB-129, an oral gastro-intestinal (GI)-restricted small molecule kinase inhibitor of ALK5 (TGFβRI or ALK5), intended for the treatment of Fibrostenosing Crohn’s Disease (FSCD). The trial, 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 exposure.

The Phase 1 study included single ascending dose (SAD), multiple ascending dose (MAD) and food-effect (FE) stages, as well as an additional stage for the assessment of local drug exposure in ileal mucosa, where the fibrostenotic strictures in FSCD patients are most often located. A total of 81 healthy subjects were randomized to receive either 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 signal 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 analyses showed no clinically relevant systemic exposure, whereas biopsies of the ileum showed high local concentrations of AGMB-129, confirming that the GI-restriction mechanism can operate efficiently in humans.

“The positive results of this Phase 1 study are an important first step in our clinical development of AGMB-129 and confirm its tolerability and GI-restricted mechanism,” said Philippe Wiesel, Chief Medical Officer at Agomab Therapeutics, “We look forward to advancing AGMB-129 into a global Phase 2a study in patients with Fibrostenosing Crohn’s Disease, a disease for which there are currently no medicinal products available.”