Viking Therapeutics, Inc. (‘Viking’) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced positive new findings from the company’s 12-week, Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture.
As previously reported, the trial achieved its primary endpoint, demonstrating statistically significant, dose-dependent increases in lean body mass, less head, following treatment with VK5211 as compared to placebo. Additionally, newly presented data demonstrated dose-dependent decreases in mean fat mass, coupled with dose-dependent increases in mean body weight following VK5211 treatment. Findings also demonstrated dose-dependent increases in 6-minute walk distance following VK5211 treatment, reaching a greater than 20-meter improvement over placebo at the study’s highest dose. The results were presented as part of the oral plenary session of the American Society for Bone and Mineral Research (ASBMR) 2018 annual meeting, held September 28 – October 1, 2018 in Montreal, Quebec, Canada.
VK5211, Viking’s lead program for musculoskeletal 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 Phase 2 clinical trial was a randomized, double-blind, placebo-controlled, parallel group, international study designed to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery. A total of 108 patients were randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks.
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