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Viking Therapeutics, Inc , a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, announced that enrollment has been completed in the company’s ongoing Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture.
VK5211, the company’s lead program for muscle and bone disorders, is an orally available, non-steroidal selective androgen receptor modulator (SARM) designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate. The company believes these characteristics may provide important benefits to patients recovering from hip fracture.
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery. A total of 108 patients have been randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks. The study’s primary endpoint will evaluate 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 pharmacokinetics. Viking expects to announce results from this trial in the fourth quarter.
“We are excited to have reached this important milestone with our VK5211 program and look forward to reporting top-line data later this year,” said Brian Lian, Ph.D., chief executive officer of Viking. “Prior results from studies evaluating VK5211 in animals and humans have demonstrated promising anabolic effects on bone and muscle mass. These characteristics highlight the potential benefits VK5211 may provide in patients recovering from hip fracture, an injury that results in more than 300,000 hospitalizations in the U.S. each year. Following the fracture, patients are prone to accelerated losses of bone and muscle, resulting in prolonged disability, morbidity, and risk of mortality. We believe VK5211’s potent anabolic effects on bone and muscle have the potential to address many of the key unmet needs of these individuals.”
About VK5211
VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) in Phase 2 development for the treatment of patients recovering from non-elective hip fracture surgery. VK5211 belongs to a family of novel orally available, non-steroidal SARM compounds based on tissue-specific gene expression and other functional, cell-based technologies. Viking believes that VK5211 has the potential to produce the therapeutic benefits of testosterone with improved safety, tolerability and patient acceptance due to a tissue-selective mechanism of action and an oral route of administration. In Phase 1 clinical trials, VK5211 demonstrated statistically significant increases in lean body mass among treated subjects following 21 days of treatment. In a pre-clinical model of osteoporosis, VK5211 demonstrated improvements in bone mineral density, bone mineral content, bone strength, and other measures.
About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders. The company’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives. Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated. The company’s clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist in Phase 2 development for hypercholesterolemia and fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Viking is also developing novel and selective agonists of the thyroid beta receptor for GSD Ia and X-linked adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.
For further information: Viking Therapeutics, Inc.,
Greg Zante, VP,
Finance and Operations,
858-704-4672;
Vida Strategic Partners,
Stephanie Diaz (Investors),
415-675-7401,
sdiaz@vidasp.com;
Tim Brons (Media),
415-675-7402,
tbrons@vidasp.com
