Viking's VK5211 meets primary in Phase II for acute hip fracture

Viking Therapeutics Inc. (NASDAQ:VKTX) said VK5211 met the primary endpoint of increasing lean body mass from baseline to week 12 vs. placebo in a Phase II trial in patients recovering from acute hip fracture surgery. The company said it designed VK5211, a non-steroidal selective androgen receptor modulator (SARM), to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as the skin and prostate. Data were presented at the American Society for Bone and Mineral Research meeting in Montreal.

The double-blind, international trial enrolled 108 hip fracture patients ages 65 and older to receive placebo or once-daily 0.5, 1 or 2 mg oral VK5211 for 12 weeks. On the primary endpoint, VK5211 led to significant, dose-dependent, placebo-adjusted increases in total lean body mass (except in the head) from baseline to week 12 of 4.8% at the 0.5 mg dose (p=0.0032), 7.2% at the 1 mg dose (p<0.0001) and 9.1% at the 2 mg dose (p<0.0001). Additionally, high-dose VK5211 significantly reduced mean fat mass from baseline to week 12 vs. placebo (placebo-adjusted reduction of 6.2%, p=0.01). Viking said VK5211 also led to increases in mean body weight of 2.54 kg at the 0.5 mg dose, 2.95 kg at the 1 mg dose and 3.09 kg at the 2 mg dose...