Press release
Keros Therapeutics Announces Initial Topline Results from the Phase 1 Clinical Trial of KER-065 in Healthy Volunteers
Trial achieved key objectives for safety, tolerability, pharmacokinetics and pharmacodynamicsClinical data from this trial, together with preclinical data,
About this update from Keros Therapeutics, Inc.
[{"type":"text","content":"Trial achieved key objectives for safety, tolerability, pharmacokinetics and pharmacodynamicsClinical data from this trial, together with preclinical data, support the therapeutic potential of KER-065 for broad impact in Duchenne muscular dystrophy (“DMD”) and other neuromuscular indicationsKeros plans on advancing KER-065 into a Phase 2 clinical trial in DMD, subject to positive regulatory interactionKeros to host a conference call and webcast today, March 31, 2025, at 8:00 a.m. ET LEXINGTON, Mass., March 31, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced initial topline results from the Phase 1 clinical trial of KER-065 in healthy volunteers. Topline results from this ongoing trial are through the multiple ascending dose (“MAD”) treatment period (Day 85). “We are pleased to report topline results that met the key objectives of the Phase 1 clinical trial and provided important insights to inform the development of KER-065 for patients with DMD,” said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. “Considering the limitations of currently available therapies, the need for additional treatments in DMD remains high, and KER-065 has the potential to address multiple aspects of the disease, including across important tissues and underlying genetic deficiencies. Our strong financial foundation enables us to continue advancing our promising pipeline of novel therapeutics, and we look forward to engaging with regulators towards the aim of moving KER-065 to a Phase 2 clinical trial in the first quarter of 2026.” Key findings of this trial as of a February 6, 2025 data cut-off date include the following: KER-065 was generally well-tolerated, with no major safety signals observed to date No serious adverse events or dose-limiting toxicities reported Evidence for activin inhibition across tissues of interest, as KER-065 elicited: Increases in bone specific alkaline phosphate (BSAP), a biomarker of bone formation, and decreases in C-Terminal Telopeptide (CTX), a biomarker of bone resorptionIncreases in adiponectin, a biomar...