SARMs such as VK5211 are a class of small molecules designed to elicit the benefits of androgens on tissues such as muscle and bone, without the undesirable effects on prostate and sebaceous glands, by selectively activating androgen receptors in certain tissues. This results in a loss of muscle strength, an increased risk of additional fractures and increased mortality. These patients experience elevated rates of metabolic breakdown of muscle tissue and loss of bone mineral density, or BMD. Tissue selectivity is critical in treating patients recovering from hip fracture. Testosterone stimulates the growth of muscle and bone (anabolic effects), as well as the growth of the prostate and sebaceous gland (androgenic effects) and, as such, testosterone is considered a non-tissue-selective androgen. In 3 previous Phase 1 clinical trials, VK5211 was shown to be safe and well-tolerated at all doses following daily oral administration for up to 21 days.Īndrogens, of which the most predominant is testosterone, are important for the proper regulation of the reproductive system and play critical roles in the homeostasis of the muscular, skeletal, cardiovascular, metabolic and central nervous systems. VK5211 demonstrated encouraging safety and tolerability in this study, with no drug related serious adverse events (SAEs) reported. These endpoints were not powered for significance. Patients receiving VK5211 demonstrated numerical improvements in certain exploratory assessments of functional performance, including the 6-minute walk test (6MWT) and short physical performance battery (SPPB), compared with placebo. The trial demonstrated statistically significant increases in total lean body mass less head, appendicular lean body mass, and total lean body mass, following treatment with VK5211 as compared to placebo. We have completed a Phase 2 proof-of-concept clinical trial of VK5211 in patients recovering from non-elective hip fracture surgery. VK5211 is designed to selectively produce the therapeutic benefits of testosterone in muscle and bone tissue with improved safety and tolerability due to a tissue-selective mechanism of action and an oral route of administration. VK5211 is an orally available, non-steroidal selective androgen receptor modulator, or SARM, in development for the treatment of patients recovering from non-elective hip fracture surgery. Selective Androgen Receptor Modulator (SARM) Hip Fracture, Muscle Wasting
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