Viking Therapeutics starts VK5211 clinical development program

VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) being developed to treat patients recovering from non-elective hip fracture surgery.

Investigators have dosed the initial subjects in the first part of the VK5211 program, which features a brief safety, tolerability and pharmacokinetic study in healthy elderly subjects.

A randomized, double-blind, parallel group, placebo-controlled Phase 2 study will then be undertaken to identify the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery.

The company will enroll about 120 patients in the efficacy study with the primary aim to identify the effects of VK5211 on lean body mass after 12 weeks of treatment.

Secondary and exploratory objectives include assessments of functional performance, quality-of-life and activities of daily living, as well as safety, tolerability and pharmacokinetic assessments.

The first patient in the efficacy study is expected to be dosed in the fourth quarter.

Viking Therapeutics chief executive officer Brian Lian said: "We believe VK5211 has the potential to meet a significant unmet medical need in the hip fracture setting based on the drug’s potent anabolic effect on both lean body mass and bone mineral density.

"These unique characteristics may benefit patients recovering from surgery, where loss of muscle and bone contribute to the poor recoveries and increased risk of further complications that are often observed."