Merck announced that remigromig, an investigational tri-specific antibody that activates the Wnt pathway, met the primary endpoint in the pivotal Phase 2b/3 BRUNELLO trial in adults with diabetic macular edema, with both dose arms demonstrating non-inferiority in mean change from baseline in best corrected visual acuity at one year versus monthly 0.5mg ranibizumab. Mean BCVA gains at Year 1 were +9.1 letters with remigromig 0.5 mg and +8.7 letters with remigromig 0.8 mg, compared with +11.8 letters with ranibizumab, and no secondary endpoints demonstrated superiority to ranibizumab. The company said remigromig is the first biologic with a novel mechanism of action to demonstrate non-inferior visual acuity compared with anti-VEGF therapy in a pivotal DME trial, and the first new mechanism of action in more than 20 years to do so. Adverse events related to proliferative diabetic retinopathy occurred more frequently with remigromig than with ranibizumab, at 6.7% and 6.1% for the 0.5 mg and 0.8 mg arms versus 0.9%, and treatment discontinuations due to adverse events were also higher, at 4.9% and 4.5% versus 0.9%. The results, presented at the American Academy of Ophthalmology 2026 Annual Meeting in New Orleans, will be discussed with regulatory authorities, and remigromig is also being evaluated in the ongoing pivotal Phase 2b/3 BAROLO study in DME and a Phase 2 proof-of-concept study in NVAMD and RVO.
Merck KGaARemigromig met the primary endpoint in the pivotal BRUNELLO DME trial, a positive R&D/clinical result for Merck KGaA.
Merck & Company Inc