Agomab stock jumps on positive trial data

Investing.com -- Agomab Therapeutics Nv (NASDAQ: AGMB) shares rose 6.3% in premarket trading Thursday following positive topline results from the open-label extension study of its experimental drug ontunisertib for fibrostenosing Crohn's disease.

The company reported favorable safety and tolerability data through up to 60 weeks of treatment in the STENOVA trial extension study. The trial showed a low annualized disease-related event rate of 3%, with one endoscopic balloon dilation and no surgeries reported during the full treatment period.

Of the 49 patients who entered the 48-week open-label extension, representing 94% of eligible participants from the initial 12-week placebo-controlled portion, 37 completed the study. The results demonstrated sustained disease control across symptoms and disease activity scores, with radiological assessment showing a trend for fibrotic stricture stabilization.

The drug maintained a gut-restricted pharmacokinetic profile with low systemic exposure throughout the extended treatment period. Five serious adverse events were reported in four patients during the extension study, all considered unrelated or unlikely related to the treatment. No signals of cardiac injury, pro-inflammatory effects, vasculitis, liver toxicity or thrombotic events were observed.

At Week 48 of the extension study, 97% of evaluable patients were in clinical remission as measured by the Crohn's disease activity index score.

The results support the initiation of Agomab's global NOV-ERA Phase 2b study, planned to begin in the coming months. The trial will evaluate ontunisertib in approximately 320 patients with symptomatic fibrostenosing Crohn's disease across three dose levels.

Ontunisertib is an investigational oral drug designed to inhibit ALK5 in the gastrointestinal tract and has received FDA Fast Track Designation. The company plans to present detailed extension study results at a future scientific conference.

Original Article

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