SAN DIEGO, Dec. 7, 2015 /PRNewswire/ -- 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 new data from a preclinical study examining the physiologic impact of VK5211 in primates following 13 weeks of treatment. Study findings showed robust weight gains in all VK5211 treatment groups as compared to both baseline and controls. Importantly, treated cohorts demonstrated progressive weight gain throughout the course of treatment and retained a substantial portion of the increased weight post-treatment. The results were presented in a poster at the 8th International Conference on Cachexia, Sarcopenia and Muscle Wasting, held December 4-6, 2015 in Paris, France.
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. A Phase 2 clinical trial of VK5211 in up to 120 patients who recently suffered a hip fracture is currently underway.
In the primate study, oral VK5211 was administered once-daily at doses of 0.6, 3, 15 and 75 mg/kg to cynomolgus monkeys for up to 13 weeks. Control cohorts were administered a vehicle formulation excluding VK5211. At 13 weeks, treated animals demonstrated mean body weight gains of 20 to 47 percent from their baseline measurements. The increases in body weight were 29 to 157 percent greater than the control cohort in males, and 100 to 267 percent greater than controls in females. Significant mean weight gains of up to 1.5 kg were observed in the combined sexes, from 3.5 to 3.6 kg at baseline. Importantly, VK5211-treated cohorts were shown to effectively maintain their increased weight, retaining 70% or more of their gains over a four-week recovery period following discontinuation of dosing.
The safety of VK5211 was also evaluated in this study. No ophthalmic, electrocardiographic or heart rate changes were observed with VK5211 dosing. In addition, no significant changes to clinical chemistry or hematologic factors were observed. Minimal to moderate alterations in clinical pathology parameters that were consistent with potent stimulation of the androgen receptor were observed in VK5211-treated cohorts. These findings are not anticipated to result in safety concerns in an elderly human population.
"These results build upon the impressive anabolic responses observed in prior studies of VK5211. The significant increases in weight observed in this study, which continued through the entire 13 week treatment window, are quite promising and consistent with data from a previous human Phase 1 study, which demonstrated increases in muscle mass after only three weeks of exposure," said Brian Lian, Ph.D., chief executive officer of Viking. "We believe such effects, if replicated in further human studies, could provide benefits in settings where patients experience abnormal losses of muscle. We recently announced the initiation of a 12 week Phase 2 trial of VK5211 in patients recovering from hip fracture, a large population known to experience prolonged disability and increased risks of re-fracture due to muscle and bone loss. Today's results provide additional reasons to be enthusiastic about the potential benefits of VK5211 on muscle growth and we are excited to continue our aggressive development plan for this important therapy."
In addition to the ongoing Phase 2 trial of VK5211 in hip fracture patients, Viking is preparing to initiate later this year a Phase 2 study of VK2809, a novel, orally available small molecule thyroid receptor agonist, in patients with hypercholesterolemia and fatty liver disease. The company is also developing VK0214, a novel thyroid beta agonist, for the treatment of X-linked adrenoleukodystrophy (X-ALD). Under a recently-signed research collaboration, scientists at the Kennedy Krieger Institute are studying VK0214 in in vivo models of X-ALD.
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 entering 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 adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.
This press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking's expectations regarding its development activities, timelines and milestones, as well as VK5211's potential to produce therapeutic benefits. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials; and risks regarding regulatory requirements, among others. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements.
SOURCE Viking Therapeutics, Inc