US-based clinical-stage biopharmaceutical company Viking Therapeutics has reported positive Phase I trial data of VK5211 in treating muscle and bone disorders.
VK5211 is an orally administered, non-steroidal, selective androgen receptor modulator (SARM) being developed to treat patients recovering from non-elective hip fracture surgery.
It is based on tissue-specific gene expression and other functional, cell-based technologies, and is designed to specifically trigger muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate.
The Phase I study was designed as a single-site, in-clinic trial intended to test the safety and pharmacokinetics (PK) profile of VK5211.
The trial involved 24 healthy subjects aged 65 and older, comprising both men and women who suffered from general hip fracture.
The patients were orally administered with VK5211 on a once-daily basis for seven days and were later examined for safety, pharmacokinetics, and hormonal alterations.
Results suggested a consistent PK profile of VK5211 in older patients with a tolerable profile maintained throughout the study.
VK5211 was observed to have resulted in transient changes within lipids and hormonal patterns associated with the hypothalamic-pituitary-adrenal axis.
Viking chief executive officer Brian Lian said: "The VK5211 clinical results obtained to date demonstrate an encouraging overall safety and tolerability profile, as well as promising effects on muscle growth following relatively brief exposures.
"We expect our ongoing Phase II trial to provide further support for the development of VK5211 in the hip fracture and potentially other settings."
Vikings is also conducting the Phase II study of VK5211 in patients recovering from hip fracture surgery.