Keros Therapeutics, 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).
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Key Findings from KER-065
- 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 resorption
- Increases in adiponectin, a biomarker of fat mobilization, and decreases in leptin, a biomarker of fat mass
- Changes in body composition, as demonstrated by increases in bone mineral density and muscle mass and decreases in fat mass, which in totality were consistent with activin inhibition
About the KER-065 Phase 1 Clinical Trial
The KER-065 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, two-part dose escalation (single ascending dose and MAD) trial in healthy 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. (Read More)
About KER-065
KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB that is fused to the portion of the human antibody known as the Fc domain. KER-065 is designed to act as a ligand trap and inhibit the biological effects of myostatin and activin A, two ligands that signal through activin receptors, to increase skeletal muscle regeneration, increase muscle size and strength, reduce body fat, reduce fibrosis of the skeletal muscle and increase bone strength. We are developing KER-065 for the treatment of neuromuscular diseases, with an initial focus on DMD.
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