Viking Therapeutics says Phase 2 study of VK5211 achieves primary endpoint

Viking Therapeutics 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. VK5211, Viking’s lead program for musculoskeletal disorders, is an orally available, non-steroidal selective androgen receptor modulator 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. Key results presented at ASBMR included: All doses of VK5211 demonstrated statistically significant increases in total lean body mass, less head, following 12 weeks of treatment, the study’s primary endpoint. Placebo-adjusted increases in lean body mass were 4.8% at 0.5 mg, 7.2% at 1.0 mg, and 9.1% at 2.0 mg. Patients receiving VK5211 experienced dose-dependent decreases in mean fat mass following 12 weeks of treatment, which reached statistical significance at the study’s highest dose of 2.0 mg. Placebo-adjusted reductions in mean fat mass were approximately 2.2% at 0.5 mg, 5.4% at 1.0 mg, and 6.2% at 2.0 mg. The observed reductions in mean fat mass were coupled with dose-dependent increases in mean body weight following 12 weeks of treatment, demonstrating beneficial changes in overall body composition among VK5211-treated subjects. The increases in mean body weight were 2.54 kg at 0.5 mg, 2.95 kg at 1.0 mg, and 3.09 kg at 2.0 mg. Patients receiving VK5211 demonstrated dose-dependent improvements in the 6-minute walk distance as compared to placebo, though this exploratory endpoint was not powered for significance. For patients in the 2.0 mg VK5211 treatment arm, the mean distance increased by approximately 22 meters compared to placebo. VK5211 treatment resulted in statistically significant improvements compared to placebo in serum procollagen type 1 propeptide, a marker of anabolic bone turnover, at 12 weeks. Patients were also assessed 12 weeks after completion of the study to evaluate safety and efficacy at 24 weeks. At this 24-week timepoint, the increases in total lean body mass, less head, for all VK5211 treatment arms remained above placebo, though the increases were no longer statistically significant. The durable increases in muscle mass that were maintained three months following the last dose of VK5211 highlight the potent treatment effect VK5211 demonstrated in these patients. No drug-related SAEs were observed in patients receiving VK5211. There were no significant differences in the rates of adverse events reported among patients receiving VK5211 compared with placebo. There were no dose-related differences in reported adverse events among various VK5211 treatment groups.

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