Biomea Fusion BMF-650 Phase 1 Weight Loss Results Remain Preliminary, With Longer-Term Trials And Toxicology Studies Still Outstanding

Safety and Tolerability

Across the five active-dose MAD cohorts (n=40), all reported treatment-emergent adverse events (TEAEs) were mild or moderate. There were no severe or serious TEAEs, TEAE-related dose modifications, or TEAE-related study discontinuations. In the highest dosing group, Cohort 5, nausea and vomiting were each reported in one of eight BMF-650-dosed participants (12.5%), constipation in two (25%) and diarrhea in none (0%); these gastrointestinal ("GI") events were all Grade 1. Across all active MAD cohorts, nausea occurred in 17.5%, vomiting in 7.5%, constipation in 10%, and diarrhea in 5% of participants. No adverse events of increased Alanine Aminotransferase ("ALT")/ Aspartate Aminotransferase ("AST") were reported. These findings are preliminary and reflect outcomes from four weeks of treatment.