Keros Therapeutics, Inc. announced initial topline results from its Phase 1 clinical trial of KER-065 in healthy volunteers, with data through the multiple ascending dose treatment period (Day 85). The trial successfully met its key objectives for safety, tolerability, and pharmacokinetics.
The results demonstrated evidence of activin inhibition based on multiple biomarkers and body composition data. These findings, combined with preclinical and mechanistic insights, support the therapeutic potential of KER-065 for Duchenne muscular dystrophy (DMD) and other neuromuscular disorders.
Keros plans to engage with regulatory authorities starting in the third quarter of 2025, with the goal of initiating a Phase 2 clinical trial of KER-065 in DMD patients in the first quarter of 2026. This advancement positions KER-065 as a key focus for the company's pipeline.
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