Merck’s Remigromig, a Tri-specific Agonist of the Wingless-related Integration Site (Wnt) Pathway, Met Primary Endpoint in the Pivotal Phase 2b/3 BRUNELLO Study of Adults with Diabetic Macular Edema
Merck's remigromig (MK-3000) met the primary endpoint in the pivotal Phase 2b/3 BRUNELLO trial, with both 0.5 mg and 0.8 mg doses showing non-inferiority to ranibizumab on mean BCVA change at week 52 in adults with diabetic macular edema. The 984-participant trial is the first of two pivotal DME studies, and the drug carries a potentially first-in-class Wnt-pathway mechanism — the first new mechanism to reach Phase 3 non-inferiority results against anti-VEGF therapy in 20 years. Safety bears watching: the remigromig arms showed higher rates of proliferative diabetic retinopathy, vitreous hemorrhage, and discontinuations due to adverse events, with further analyses underway.
Key figures
- Drug Name
- remigromig (MK-3000, formerly EYE103)
- Phase Of Trial
- Phase 2b/3
- Endpoint
- non-inferiority in mean change from baseline BCVA at week 52 vs 0.5 mg ranibizumab
- Enrolled
- 984
- Trial name
- BRUNELLO
- Doses tested
- ["0.5 mg","0.8 mg"]
- Us dme patients
- 1.6 million
- Non responder rate
- up to 40%
AI analysis
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