GTx: Women treated with enobosarm showed reduction in incontinence episodes
GTx announced release of preliminary clinical data from its ongoing, open-label, Phase 2 clinical trial of enobosarm 3 mg in postmenopausal women with stress urinary incontinence. An abstract entitled "Kegels In A Bottle": Preliminary Results Of A Selective Androgen Receptor Modulator For The Treatment Of SUI In Post-Menopausal Women, summarizing clinical data from the first seven patients completing 12 weeks of treatment with enobosarm, is now available on the International Continence Society's website. This proof-of-concept clinical trial is the first of its kind to evaluate an orally-administered selective androgen receptor modulator for SUI. In this ongoing Phase 2 clinical trial, enobosarm 3 mg is being given to post-menopausal women who have demonstrated SUI symptoms for more than six months, with 3 to 15 reported SUI episodes per day averaged over a three-day period, and a positive bladder stress test. The primary endpoint is the number of SUI episodes per day on the 3-day voiding diary at 12 weeks, compared to base line. The clinical findings from the first seven patients enrolled in the study following their completion of treatment, are: Each of the women treated with enobosarm showed a clinically significant reduction in incontinence episodes per day: Mean stress leaks decreased by 80.9 percent from baseline over 12 weeks; Stress leaks decreased from a mean of 5.7 leaks/day at baseline, to 1.1 leaks/day at Week 12; All patients saw at least a 65 percent reduction in number of stress leaks; Reductions in incontinence episodes were sustained well beyond the stopping of study drug at Week 12: Patients demonstrated continued reduction in incontinence episodes for up to five months; Women reported improved quality of life in the Patient Global Impression of Improvement (PGI-I) and Female Sexual Function Index; At Week 12, all seven patients showed improved PGI-I scores and 5 of 7 patients showed improvement in FSFI. Enrollment in the Phase 2 proof-of-concept clinical trial of 3 mg of enobosarm in women with SUI is ongoing.