Keros Therapeutics, Inc. (Nasdaq: KROS) announced on September 28, 2026, that the first patient has been dosed in a Phase 2 clinical trial evaluating rinvatercept for the treatment of Duchenne muscular dystrophy (DMD). The trial, identified by clinical trial number NCT07704099, is an open-label, multi-cohort basket study designed to assess the safety and tolerability of the drug in late-ambulatory and early non-ambulatory patients.
The primary objective of the trial is to evaluate the safety profile of rinvatercept in this specific patient population. Secondary objectives include a comprehensive assessment of the drug's pharmacokinetics, the presence of anti-drug antibodies, and changes in body composition. Additionally, the trial will look for functional improvements across skeletal muscle, motor function, cardiac health, and pulmonary capacity.
Rinvatercept is a novel ligand trap designed to inhibit the biological effects of myostatin and activin A, which are proteins that negatively regulate muscle and bone mass. The company states that the drug aims to improve skeletal muscle regeneration, increase muscle size and strength, reduce fibrosis, and improve bone health. Keros Therapeutics is developing rinvatercept for both DMD and amyotrophic lateral sclerosis (ALS).
Keros is a clinical-stage biopharmaceutical company focused on disorders linked to dysfunctional signaling of the transforming growth factor-beta (TGF-β) family of proteins. The company noted that initial data from the trial is expected in the first half of 2027.