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SAN DIEGO, Oct. 1, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced positive new findings from the company's 12-week, Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture. As previously reported, the trial achieved its primary endpoint, demonstrating statistically significant, dose-dependent increases in lean body mass, less head, following treatment with VK5211 as compared to placebo. Additionally, newly presented data demonstrated dose-dependent decreases in mean fat mass, coupled with dose-dependent increases in mean body weight following VK5211 treatment. Findings also demonstrated dose-dependent increases in 6-minute walk distance following VK5211 treatment, reaching a greater than 20-meter improvement over placebo at the study's highest dose. The results were presented as part of the oral plenary session of the American Society for Bone and Mineral Research (ASBMR) 2018 annual meeting, held September 28 – October 1, 2018 in Montreal, Quebec, Canada.
VK5211, Viking's lead program for musculoskeletal 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 Phase 2 clinical trial was a randomized, double-blind, placebo-controlled, parallel group, international study designed to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery. A total of 108 patients were randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks.
Key results presented at ASBMR included:
- All doses of VK5211 demonstrated statistically significant increases in total lean body mass, less head, following 12 weeks of treatment, the study's primary endpoint. Placebo-adjusted increases in lean body mass were 4.8% at 0.5 mg (p = 0.0032), 7.2% at 1.0 mg (p < 0.0001), and 9.1% at 2.0 mg (p < 0.0001).
- Patients receiving VK5211 experienced dose-dependent decreases in mean fat mass following 12 weeks of treatment, which reached statistical significance at the study's highest dose of 2.0 mg. Placebo-adjusted reductions in mean fat mass were approximately 2.2% at 0.5 mg, 5.4% at 1.0 mg, and 6.2% at 2.0 mg (p = 0.01).
The observed reductions in mean fat mass were coupled with dose-dependent increases in mean body weight following 12 weeks of treatment, demonstrating beneficial changes in overall body composition among VK5211-treated subjects. The increases in mean body weight were 2.54 kg at 0.5 mg, 2.95 kg at 1.0 mg, and 3.09 kg at 2.0 mg.
- Patients receiving VK5211 demonstrated dose-dependent improvements in the 6-minute walk distance as compared to placebo, though this exploratory endpoint was not powered for significance. For patients in the 2.0 mg VK5211 treatment arm, the mean distance increased by approximately 22 meters compared to placebo.
- VK5211 treatment resulted in statistically significant improvements compared to placebo in serum procollagen type 1 propeptide (s-P1NP), a marker of anabolic bone turnover, at 12 weeks.
- Patients were also assessed 12 weeks after completion of the study to evaluate safety and efficacy at 24 weeks. At this 24-week timepoint, the increases in total lean body mass, less head, for all VK5211 treatment arms remained above placebo, though the increases were no longer statistically significant. The durable increases in muscle mass that were maintained three months following the last dose of VK5211 highlight the potent treatment effect VK5211 demonstrated in these patients.
- No drug-related SAEs were observed in patients receiving VK5211. There were no significant differences in the rates of adverse events reported among patients receiving VK5211 compared with placebo. There were no dose-related differences in reported adverse events among various VK5211 treatment groups.
"This study highlights the impressive efficacy and safety of VK5211 in a population where no treatment option currently exists. The impressive changes to weight and lean body mass, which exceeded six pounds in the highest dose group, demonstrate VK5211's potent effect in patients who are often characterized as frail and prone to prolonged disability. It is striking that these increases were coupled with reductions in fat mass, indicating a favorable shift in overall body composition," said Brian Lian, Ph.D., chief executive officer of Viking. "In addition, while the study was not powered to demonstrate statistical significance on exploratory endpoints, we are encouraged by the dose-dependent increases in 6-minute walk distance, which exceeded placebo by more than 20 meters at the study's highest dose, suggesting a potential functional benefit to patients. Finally, we are pleased with the safety and tolerability of VK5211 in this study, with no drug-related serious adverse events observed and no clinically meaningful changes in important markers such as hemoglobin, red blood cell counts and coagulation factors."
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.
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. The company's clinical programs include VK2809, a small molecule thyroid beta agonist. In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content. VK2809 was shown to be safe and well-tolerated in the study. The company's second clinical program is VK5211, an orally available, non-steroidal selective androgen receptor modulator. In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared to patients who received placebo. The company is also developing VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Additional programs include 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. Viking holds exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
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 the company's goals and plans regarding VK5211 and VK5211's prospects. 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, including those for VK5211 and VK2809; risks that prior clinical and pre-clinical results may not be replicated; 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.