Agomab Therapeutics Experimental Drug Delivers Sustained Disease Control in Long-Term Crohn's Disease Trial
Agomab Therapeutics NV (NASDAQ: AGMB ) reported results from the 48-week open-label extension portion of its Phase 2a STENOVA trial of ontunisertib for fibrostenotic Crohn’s disease. • AgomAb Therapeutics stock is showing notable weakness. Why is AGMB stock dropping? The data demonstrated sustained disease control, long-term safety, and low complication rates for patients receiving treatment for up to 60 weeks. In the extension phase, 94% of eligible participants from the initial 12-week placebo-controlled study chose to enroll. Patients received 200 mg of ontunisertib twice daily alongside standard care. Investigators recorded an annualized disease-related event rate of just 3%, as only one patient required an endoscopic balloon dilation procedure and none advanced to surgery. Comparative published data show similar patient populations on advanced therapies typically face annualized event rates between 23% and 35%. Read Also: AbbVie Says 55% Of Crohn's Patients Reached Remission With Skyrizi, Bolsters Competitive Positioning Against Johnson & Johnson Long-Term Safety and Pharmacokinetic Profile Ontunisertib demonstrated a favorable safety and tolerability profile throughout the ex
Agomab Therapeutics NV (NASDAQ: AGMB ) reported results from the 48-week open-label extension portion of its Phase 2a STENOVA trial of ontunisertib for fibrostenotic Crohn’s disease. • AgomAb Therapeutics stock is showing notable weakness. Why is AGMB stock dropping? The data demonstrated sustained disease control, long-term safety, and low complication rates for patients receiving treatment for up to 60 weeks.
In the extension phase, 94% of eligible participants from the initial 12-week placebo-controlled study chose to enroll. Patients received 200 mg of ontunisertib twice daily alongside standard care. Investigators recorded an annualized disease-related event rate of just 3%, as only one patient required an endoscopic balloon dilation procedure and none advanced to surgery. Comparative published data show similar patient populations on advanced therapies typically face annualized event rates between 23% and 35%.
Read Also: AbbVie Says 55% Of Crohn's Patients Reached Remission With Skyrizi, Bolsters Competitive Positioning Against Johnson & Johnson Long-Term Safety and Pharmacokinetic Profile Ontunisertib demonstrated a favorable safety and tolerability profile throughout the extended dosing period. Four patients reported five serious adverse events during the extension, all considered unrelated or unlikely related to study treatment. The study revealed no signs of liver toxicity, cardiac injury, thrombotic events, vasculitis or pro-inflammatory side effects.
The candidate maintained a gut-restricted pharmacokinetic profile, keeping systemic drug exposure low and plasma levels well below IC50 thresholds. Imaging Results and Patient Outcomes Magnetic resonance enterography assessments at Weeks 24 and 48 indicated radiological stabilization of fibrotic strictures. Patients who transitioned from placebo to ontunisertib stabilized and caught up with participants who took the drug from the start. By Week 48 of the extension study, 97% of evaluable patients achieved clinical remission based on Crohn’s Disease Activity Index scores.
Upcoming Clinical Steps Following these results, the company completed regulatory filings for NOV-ERA, a global Phase 2b trial. The upcoming study will evaluate approximately 320 patients across three twice-daily dose levels — 400 mg, 200 mg, and 100 mg — against a placebo. 13 at the time of publication on Thursday, according to Pro data. 4 Billion Fed