GTx, a Memphis-based biopharmaceutical company, has announced that the FDA has accepted the company’s investigational new drug (IND) application for a phase II clinical trial to treat postmenopausal women with stress urinary incontinence (SUI). The IND enables GTx to initiate a phase II proof-of-concept trial of enobosarm that will be the first clinical trial to evaluate a selective androgen receptor modulator (SARM) for SUI. The company plans to initiate the trial by the first quarter of 2016 and anticipates top-line data later in 2016.
The rationale for evaluating enobosarm (GTx-024) as a treatment for SUI in the proof-of-concept trial is supported by preclinical in vivo data demonstrating increases in pelvic floor muscle mass following treatment with GTx’s SARM compounds, including enobosarm, as well as human safety and efficacy data from enobosarm clinical trials involving more than 1,500 subjects. Enobosarm has been found to be generally safe and well-tolerated. Following results from the proof-of-concept trial, the company will determine which GTx SARM compound, including enobosarm, may be further developed for this indication.