Biomea Fusion: FDA, Health Canada Approve Initiation Of Expansion Portion Of COVALENT-111

(RTTNews) - Biomea Fusion, Inc. (BMEA) announced FDA and Health Canada clearance of the expansion portion of the ongoing COVALENT-111 Phase II study. The objective of the expansion portion is to continue to investigate BMF-219 with treatment durations up to 12 weeks in type 2 diabetes patients.

The company said the expansion portion will consist of approximately 300 patients and will begin to enroll three cohorts immediately, with a fourth cohort following the completion of the escalation portion. The company expects topline results of the escalation portion in fourth quarter, 2023.

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