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Viking’s VK5211 meets primary endpoint in phase 2 hip fracture trial

PBR Staff Writer Published 29 November 2017

Viking Therapeutics’ hip fracture treatment VK5211 has met primary endpoint in a 12-week phase 2 clinical trial.

The trial showed statistically significant and dose dependent increases in lean body mass and less head following treatment with VK5211 compared against placebo.

In addition, the study also reached secondary endpoints, demonstrating statistically significant increases in appendicular lean body mass and total lean body mass for all doses of VK5211 compared against placebo.

VK5211 is an orally available and non-steroidal selective androgen receptor modulator (SARM) that will selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate.

The randomized, double-blind, placebo-controlled, parallel group and international study was launched to assess the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery.  

Viking recruited a total of 108 patients and randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks. 

According to the company, all doses of VK5211 demonstrated statistically significant increases in total lean body mass, less head, the study's primary endpoint, which is the study's primary endpoint.

Viking CEO Brian Lian said: "We are pleased that this trial succeeded in both the primary efficacy endpoint, as well as important secondary endpoints, demonstrating VK5211's potential benefit in this setting.  

“The study achieved statistical significance at all doses with a clear dose-response and, in our view, provides compelling evidence of VK5211's potent pharmacologic effect on muscle growth.”