Agomab Therapeutics has reported positive data from its Phase I study of AGMB-129 to treat Fibrostenosing Crohn’s Disease (FSCD).

The trial was designed for assessing the tolerability, pharmacokinetics (PK), and safety of the oral, gastro-intestinal (GI)-restricted, small molecule kinase ALK5 (TGFbRI or ALK5) inhibitor AGMB-129 in healthy participants. TGFb is a known master fibrosis regulator.

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It included single ascending dose (SAD), multiple ascending dose (MAD), and food-effect (FE) stages.

The trial will also include an additional stage to evaluate local drug exposure in ileal mucosa, where the fibrostenotic strictures are most often located in FSCD patients.

In the trial, 81 healthy participants were randomised to receive either a single dose or multiple daily oral AGMB-129 doses, or a matching placebo.

The findings showed high local exposure to AGMB-129 in the ileum, with no drug-related safety signals or dose-limiting toxicities observed in the trial.

AGMB-129 was also found to be well-tolerated at all dosing regimens tested in the trial.

No clinically relevant systemic exposure to AGMB-129 was observed, confirming GI-tract targeted exposure.

Agomab Therapeutics stated that the favourable safety results from the Phase I study supports AGMB-129 assessment in a planned global Phase IIa study in FSCD patients.

Agomab Therapeutics chief medical officer Philippe Wiesel said: “The positive results of this Phase I study are an important first step in our clinical development of AGMB-129 and confirm its tolerability and GI-restricted mechanism.

“We look forward to advancing AGMB-129 into a global Phase IIa study in patients with Fibrostenosing Crohn’s Disease, a disease for which there are currently no medicinal products available.”