GTx reports Phase II data for enobosarm in stress urinary incontinence

GTx Inc. (NASDAQ:GTXI) reported preliminary data from 7 postmenopausal women with stress urinary incontinence in an open-label, U.S. Phase II trial showing that once-daily 3 mg Ostarine enobosarm (GTx-024) reduced the mean number of stress leaks per day to 1.1 at week 12 from 5.7 at baseline (reduction of 80.9%). All 7 patients achieved a ≥65% reduction in the number of stress leaks, with reductions in incontinence episodes continuing for up to 5 months. Additionally, all 7 patients had improved Patient Global Impression of Improvement (PGI-I) scores and 5 patients had improved Female Sexual Function Index (FSFI) scores at week 12. Data will be presented at the International Continence Society meeting in Florence in September.

The trial is slated to enroll about 35 patients with stress urinary incontinence symptoms for more than 6 months, 3-15 reported stress urinary incontinence stress urinary incontinence episodes per day averaged over a 3-day period, and a positive bladder test. The primary endpoint is the number of stress incontinence episodes per day on the 3-day voiding diary at week 12. Secondary endpoints include 24-hour pad weight test, bladder stress test, FSFI and PGI-I...