Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today announced the successful completion of a short-term safety, tolerability, and pharmacokinetic study of VK5211 in healthy elderly subjects. VK5211, the company's lead program for muscle and bone disorders, is an orally available, non-steroidal selective androgen receptor modulator (SARM) being developed for the treatment of patients recovering from non-elective hip fracture surgery. Viking plans to begin dosing hip fracture patients in a Phase 2 efficacy trial of VK5211 in the fourth quarter of 2015.
The completed study was conducted to evaluate the safety, tolerability and pharmacokinetics of VK5211 in elderly subjects, which the company believes is potentially representative of the hip fracture population. The results of this study showed VK5211 to be safe and well tolerated at all doses evaluated. No serious adverse events were observed and all subjects received all scheduled doses. In addition, VK5211 demonstrated pharmacokinetic properties similar to those previously reported in younger subjects.
Viking is proceeding with plans to initiate its previously-announced randomized, double-blind, parallel group, placebo-controlled Phase 2 study to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery. Approximately 120 patients will be enrolled in this study, with the primary objective of determining 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.
"We are pleased to have successfully completed this important portion of our VK5211 clinical development program, which confirms prior data from healthy young men and allows us to move rapidly into our planned Phase 2 hip fracture trial," said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "We look forward to enrolling the first patient in this study this quarter. In addition, we continue to make exciting progress with our other pipeline programs in lipid disorders and orphan diseases."