Agomab Shares Gain on Positive Long-Term Data for Crohn's Disease Drug

Shares of Agomab Therapeutics Nv (NASDAQ:AGMB) rose 6.3% in premarket trading Thursday after the company announced positive topline results from an extension study of its experimental drug, ontunisertib, for fibrostenosing Crohn's disease.

STENOVA Trial Shows Sustained Efficacy

The company reported favorable safety and tolerability data from the open-label extension of its STENOVA trial, which followed patients for up to 60 weeks. The results demonstrated sustained disease control and a high rate of clinical remission, paving the way for a larger study.

Key findings from the extension study include:

• A low annualized disease-related event rate of 3%, with no surgeries reported during the full treatment period.
• By week 48 of the extension, 97% of evaluable patients were in clinical remission as measured by the Crohn's disease activity index score.
• Radiological assessments showed a trend for the stabilization of fibrotic strictures.

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Of the 49 patients who entered the 48-week extension phase, representing 94% of eligible participants, 37 completed the study. Agomab stated it plans to present the detailed results at a future scientific conference.

Safety Profile and Next Steps

Agomab reported that ontunisertib maintained a gut-restricted profile with low systemic exposure throughout the extended treatment. While five serious adverse events were reported in four patients, all were considered unrelated or unlikely related to the drug. The company noted no signals of cardiac, liver, or other significant toxicities.

The positive data supports the initiation of Agomab's global NOV-ERA Phase 2b study, which is planned to begin in the coming months. The trial will evaluate ontunisertib in approximately 320 patients across three different dose levels. Ontunisertib, an investigational oral drug designed to inhibit ALK5, has previously received Fast Track Designation from the U.S. Food and Drug Administration.