GTx Phase 2 trial of enobosarm meets primary endpoint
GTx (GTXI) announced additional results from a Phase 2 proof-of-concept clinical trial of 3 mg enobosarm administered orally in postmenopausal women with stress urinary incontinence, or SUI, including magnetic resonance imaging, or MRI results from patients’ pelvic floor muscle.
New data in a subset of women also suggests a positive treatment effect of enobosarm for urge incontinence, or UI, suggesting a possible treatment effect for women with mixed incontinence.
Results from a pre-specified analysis of MRI data demonstrate a statistically significant increase in pelvic floor muscle thickness and urethral muscle diameter after enobosarm treatment.
Treatment with enobosarm also reduced mean UI episodes by approximately 68 percent in patients who experienced UI as well as SUI, based on a post hoc analysis of a subset of women with both UI and SUI.
These results were outlined during a podium presentation which took place at the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Reconstruction.
The presentation included clinical data from all 18 patients completing 12 weeks of enobosarm treatment, which, as previously reported, demonstrated an 81% reduction in the number of mean stress leaks per day, the primary endpoint of the clinical trial, as well as additional data demonstrating duration of response following completion of treatment, including nine patients who have now reached seven months post-treatment.
MRI was used to quantitatively measure muscle in the pelvic floor of 17 women at 12 weeks compared to their baseline. The results showed a statistically significant increase in several important measurements and support the mechanism of action of enobosarm on the pelvic floor.
While all of the women in the trial had predominant SUI, some also experienced urge incontinence.
Eleven of the 18 women completing 12 weeks of treatment were determined to have both SUI and UI at baseline, and these 11 women with mixed incontinence demonstrated a mean reduction in their UI episodes of approximately 68%.
Consistent with previous findings, at the end of the 12-week treatment period, all of the 18 enobosarm-treated women showed a clinically meaningful reduction in stress urinary incontinence episodes per day.
The reduction in incontinence episodes was sustained, or durable, well beyond the 12-week treatment period.
There were no serious adverse events reported and reported adverse events were minimal and included headaches, nausea, fatigue, hot flashes, insomnia, muscle weakness and acne.
Mild transient elevations in liver enzymes that were within normal limits were observed, except for one patient with levels greater than 1.5 times the upper limit of normal which returned to normal following her 12-week treatment period. Reductions in total cholesterol, LDL-C, HDL-C and triglycerides were also observed.
GTXI closed at $16.81. It last traded at $19.00 in pre-market trading.
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