Agomab Therapeutics has received the US Food and Drug Administration (FDA)’s fast track designation for AGMB-129 to treat fibrostenosing Crohn’s disease (FSCD).

Designed to inhibit ALK5 in the gastrointestinal (GI) tract, AGMB-129 is an oral, small molecule GI-restricted ALK5 (TGF-βRI) inhibitor currently in clinical development.

The single and multiple-dose AGMB-129 was well-tolerated at all doses in a Phase I study in healthy participants.

The company has also announced the commencement of the STENOVA Phase IIa clinical study to assess AGMB-129 for patients with symptomatic FSCD.

This global, placebo-controlled, multi-centre, double-blind study will assess 36 patients with symptomatic FSCD at investigational sites in Europe, Canada and the US.

Subjects will be randomised to receive one of two doses of AGMB-129 or a placebo for a period of 12 weeks.

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Tolerability and safety of AGMB-129 in FSCD patients are the primary endpoints of the trial. The pharmacokinetics and target engagement at the site of the ileal strictures are included as the secondary endpoints.

Agomab Therapeutics chief medical officer Philippe Wiesel stated: “The start of this Phase IIa clinical study is an important milestone in the development of AGMB-129.

“Intestinal strictures cause severe obstructive symptoms, are thought to induce fistulae formation and are the main cause of bowel surgery.

“Receiving the first FDA fast track designation in FSCD indicates that the FDA acknowledges the severity and unmet medical need in this indication.”