Keros Therapeutics(US:KROS) Globenewswire·2025-09-08 12:00Core Insights - Keros Therapeutics, Inc. presented additional clinical data from its Phase 1 trial of KER-065, highlighting its potential in treating Duchenne muscular dystrophy (DMD) and bone disorders [1][2] Company Overview - Keros Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting disorders linked to dysfunctional signaling of the TGF-ß protein family [8] - The company is developing KER-065, a modified activin receptor ligand trap, aimed at increasing skeletal muscle regeneration and bone strength, with an initial focus on DMD [4][8] Clinical Trial Details - The Phase 1 trial was a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, and pharmacokinetics of KER-065 in healthy male volunteers [2] - Initial topline data from the trial was reported in March 2025, with the final data cut-off on April 29, 2025 [3][6] Safety and Tolerability - KER-065 was generally well-tolerated across all tested dose levels, with no dose-limiting toxicities or serious adverse events reported [3] - One grade 4 treatment-emergent adverse event was noted but was deemed unrelated to the treatment [3] Efficacy Results - Treatment with KER-065 resulted in significant changes in bone biomarkers, indicating increased bone formation and reduced resorption [6] - Improvements in whole body bone mineral density (BMD) were observed at Day 85 and sustained through Day 141, suggesting a favorable balance between osteoblast and osteoclast activity [6] Disease Context - Duchenne muscular dystrophy (DMD) is characterized by muscle degeneration and is caused by a lack of functional dystrophin protein, leading to muscle cell damage and replacement with fibrotic and fatty tissue [5][7] - DMD affects approximately one in every 3,500 male births worldwide, with heart complications being a leading cause of death in affected individuals [7]