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news.Viking Therapeutics, a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, announced that it has submitted an investigational new drug (IND) application to the Food and Drug Administration (FDA) to initiate clinical development of VK5211 in patients with acute hip fracture.
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VK5211 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 intends to commence the clinical development program in the third quarter of 2015.
The initial portion of the planned clinical studies will evaluate the safety, tolerability, and pharmacokinetic profile of VK5211 in healthy elderly subjects.
This will be followed by a randomized, double-blind, parallel group, placebo-controlled Phase 2 study to evaluate the efficacy, safety and tolerability of VK5211 in subjects with acute hip fracture. Approximately 120 subjects will be enrolled in the efficacy 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 believe VK5211 represents a promising potential therapy for patients recovering from the devastating effects of hip fracture," said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics.
"More than 300,000 people suffer hip fractures in the U.S. each year, yet there are currently no approved therapies for restoration or preservation of lean body mass, bone mineral density or physical function in these patients. We believe that VK5211’s potential stimulatory effect on lean body mass and bone mineral density could position the drug as the first therapeutic capable of meeting the needs of hip fracture patients."
Dr. Lian continued, "Concurrent with the IND filing for our SARM program, we continue to work diligently toward advancing our additional pipeline programs and look forward to achieving further development milestones in the second half of 2015."
VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) entering 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.