Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today announced the initiation of dosing in the company's Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture. VK5211, the company's lead program for muscle and bone disorders, is an orally available, non-steroidal selective androgen receptor modulator (SARM) designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate. The company believes these characteristics may provide important benefits to patients recovering from hip fracture.
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy, safety and tolerability of VK5211 in up to 120 patients recovering from hip fracture surgery. Patients will be randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks. The study's primary endpoint will evaluate the effects of VK5211 on lean body mass after 12 weeks of treatment. Secondary and exploratory objectives include assessments of functional performance, quality-of-life, and activities of daily living, as well as safety, tolerability and pharmacokinetics.
"Initiation of this study represents a key milestone for Viking and our innovative SARM program as we work to rapidly advance the clinical development of VK5211," said Brian Lian, Ph.D., chief executive officer of Viking. "Our recently-completed Phase 1 safety and pharmacokinetic study of VK5211 in healthy elderly subjects reaffirmed previously-reported safety and tolerability characteristics of the compound, and we are excited to evaluate the treatment's efficacy in this Phase 2 trial. Patients recovering from hip fracture are known to lose bone and muscle at accelerated rates, placing them at increased risk of further morbidity, re-fracture and prolonged disability. VK5211's preliminary profile suggests robust anabolic effects on bone and muscle, potentially addressing important unmet medical needs in this population."