Viking Therapeutics starts Phase 2 trial of VK5211 in hip fracture

Under the double-blind, placebo-controlled, parallel-group study, about 120 patients will be randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg or 2.0 mg or placebo for 12 weeks.

The primary endpoint will evaluate the effects of VK5211 on lean body mass after 12 weeks of treatment.

The estimated final data collection date for the primary endpoint is October 2016, while the study is expected to be completed in March 2017.

VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) designed to produce the therapeutic benefits of testosterone.

It selectively stimulates muscle and bone formation with reduced effects in peripheral tissues like skin and prostate.

Viking Therapeutics CEO Brian Lian said: "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.

"VK5211’s preliminary profile suggests robust anabolic effects on bone and muscle, potentially addressing important unmet medical needs in this population."

In Phase 1 clinical trials, VK5211 demonstrated significant increases in lean body mass among treated subjects after 21 days of treatment.

In a pre-clinical model of osteoporosis, VK5211 showed improvements in bone mineral density, bone mineral content, bone strength, and other measures.