Keros Therapeutics presents additional clinical data from KER-065 program

Keros Therapeutics (KROS) presented additional clinical data from its Phase 1 clinical trial of KER-065 in healthy male volunteers at the American Society of Bone and Mineral Research 2025 Annual Meeting on Saturday, September 6, 2025. Phase 1 Trial in Healthy Participants of KER-065, a Modified Activin Receptor Ligand Trap, Supports Development in Duchenne Muscular Dystrophy and Bone Disorders: This Phase 1 clinical trial was a randomized, double-blind, placebo-controlled, two-part dose escalation trial in healthy male volunteers. The primary objectives of this trial were to assess safety, tolerability and pharmacokinetics of KER-065. Exploratory endpoints include assessments of the pharmacodynamic effect on bone, adipose, muscle, cardiac tissue and fibrosis. Initial topline data from this trial was reported in March 2025. As of the final data cut-off date of April 29, 2025, treatment with KER-065 was generally well-tolerated at all dose levels tested. No dose-limiting toxicities or serious adverse events were reported. One grade 4 treatment-emergent adverse event of elevated creatine kinase levels was observed, but deemed unrelated to treatment. The majority of the adverse events that were observed were mild to moderate in severity and resolved. Additional results from this trial, as of the data cut-off date, demonstrated that treatment with KER-065 resulted in: Changes in bone biomarkers of increased bone formation and reduced bone resorption that were consistent with tissue level changes, as demonstrated by observed increases in bone mineral density; Whole body BMD improvements at Day 85 that were sustained through Day 141, suggesting a balance between osteoblast and osteoclast activity; Increased lumbar spine BMD following three doses that were sustained through Day 141