GTx begins Ph II ostarine trial

US biopharmaceutical group GTx, a specialist in men's health, says that it has begun a proof-of-concept Phase II clinical assessment of ostarine, a selective androgen receptor modulator, as an agent designed to build muscle and promote bone generation. The firm argues that the drug's unique, selective anabolic activity differentiates it from other osteoporsis treatments which only treat bone loss. Preclinical studies of the drug suggest that it is effective in building and strengthening bone, in addition to increasing muscle mass and strength.

The new Phase II study will be a randomized, placebo-controlled, double-blind dose-finding assessment of ostarine in 60 elderly men and 60 postmenopausal women. Subjects will receive one of four doses of the drug or placebo each day for a period of three months. The program's endpoints include measurement of bone, fat and muscle mass.

The firm says that positive results will support the further development of the agent for indications such as acute muscle wasting, cancer and end-stage renal disease. The trial is expected to complete in the second half of the year.