GTx: Daily dose of enobosarm 3mg improved SUI in women in Phase 2 trial
GTx, Inc. announced top-line clinical trial results demonstrating that a daily dose of enobosarm 3 mg -- GTx-024 -- substantially improved stress urinary incontinence in women, as well as related quality of life measurements. In this open-label clinical trial, all 17 patients completing 12 weeks of treatment saw a clinically significant reduction in stress leaks per day, compared to baseline. Mean stress leaks decreased by 83 percent from baseline over 12 weeks, and the reductions in daily stress leaks following completion of treatment have been sustained as patients are being followed for up to 7 months post-treatment to assess the durability of treatment effect. No patient has relapsed to her baseline levels. These results were presented at the International Continence Society (ICS) Annual Meeting currently being held in Florence, Italy from September 12-15, 2017. The podium presentation entitled "Kegels In A Bottle": Preliminary Results Of A Selective Androgen Receptor Modulator For The Treatment Of SUI In Post-Menopausal Women, summarized clinical data from the first 17 patients completing 12 weeks of enobosarm treatment, including the duration of response for up to 7 months following completion of enobosarm treatment. In this trial, a total of 19 post-menopausal women were enrolled by three clinical sites to receive enobosarm treatment. In addition to the 17 patients who completed treatment, another will complete treatment in approximately 8 weeks and one patient previously withdrew consent shortly after her initial visit. Data highlights were as follows: Each of the women treated with enobosarm showed a clinically significant reduction in incontinence episodes per day: Mean stress leaks decreased by 83% percent from baseline over 12 weeks; Stress leaks decreased from a mean of 5.08 leaks/day at baseline, to 0.88 leaks/day at Week 12; All 17 patients achieved the primary endpoint of reductions in leaks per day, compared to baseline, of at least 50% at Week 12.