US-based biopharmaceutical firm Viking Therapeutics has commenced the clinical development programme of VK5211 to treat patients recovering from non-elective hip fracture surgery.
VK5211, the company’s lead programme, is an orally available, non-steroidal selective androgen receptor modulator (SARM) being developed for muscle and bone disorders.
The company noted that investigators have dosed the first subjects in the initial portion of the VK5211 clinical programme, which includes a brief safety, tolerability and pharmacokinetic study in healthy elderly subjects.
The clinical programme will be followed by a randomised, double-blind, parallel group, placebo-controlled Phase II trial to evaluate the efficacy, safety, and tolerability of VK5211 in patients recovering from hip fracture surgery.
Around 120 patients will be enrolled in the efficacy trial with the primary objective of determining the effects of VK5211 on lean body mass after 12 weeks of treatment.
The trial’s 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.
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The first patient in the efficacy trial is expected to be dosed in the fourth quarter of this year.
Viking Therapeutics chief executive officer Brian Lian said: "We believe VK5211 has the potential to meet a significant unmet medical need in the hip fracture setting based on the drug’s potent anabolic effect on both lean body mass and bone mineral density.
"These unique characteristics may benefit patients recovering from surgery, where loss of muscle and bone contribute to the poor recoveries and increased risk of further complications that are often observed.
"In addition to our exciting progress with VK5211, we are also looking forward to key near-term milestones for pipeline programs, including the planned fourth quarter initiation of a Phase II trial of our novel thyroid beta agonist VK2809 in patients with hypercholesterolemia and fatty liver disease, as well as the continued advancement of our thyroid agonist program in the orphan disease X-linked adrenoleukodystrophy (X-ALD)."
VK5211 belongs to a family of new orally available, non-steroidal SARM compounds based on tissue-specific gene expression and other functional, cell-based technologies.
According to the company, 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.