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|GTx Announced New Data Demonstrating Enobosarm’s Potential to Treat Stress Urinary Incontinence at SUFU 2018|
-- MRI results show increases in pelvic floor muscle and urethral muscle diameter supporting enobosarm’s mechanism of action --
-- Additional positive results in subset of postmenopausal women suggest dual treatment effect on urge incontinence and stress urinary incontinence --
-- Top-line results for a Phase 2 placebo-controlled clinical trial expected in the second half of 2018 --
“Enobosarm’s overall treatment effect was consistent with previously announced results, and importantly, these new results demonstrate that enobosarm may address a broader treatment need since many women suffer from symptoms of both stress and urge incontinence, also known as mixed incontinence,” said Kenneth M. Peters, M.D., Chairman of Urology, Oakland University William Beaumont School of Medicine, and the principal investigator in the trial. “In addition, with the MRI results, we are seeing anatomical changes supporting enobosarm’s mechanism of action on pelvic floor muscle.”
Magnetic Resonance Imaging (MRI) Summary of Results
Magnetic resonance imaging (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.
Urge Incontinence Summary of Results
While all of the women in the trial had predominant SUI, some also experienced urge incontinence (UI). 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 percent.
Stress Urinary Incontinence Summary of Results
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 primary endpoint of the trial).
The reduction in incontinence episodes was sustained, or durable, well beyond the 12-week treatment period.
Women reported improved quality of life measurements in various instruments collected in the study, including the Patient Global Impression of Improvement (PGI-I), Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). Improvements in Female Sexual Function Index (FSFI) were also noted. At Week 12:
Safety and Tolerability Summary
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.
About the Phase 2 Proof-of-Concept Clinical Trial
The single-arm, open-label Phase 2 clinical trial is evaluating enobosarm in postmenopausal women with SUI, and is the first clinical trial to evaluate an orally administered selective androgen receptor modulator (SARM) for SUI. In the trial, a total of 19 postmenopausal women were enrolled at three clinical trial sites to receive enobosarm treatment. A total of 18 patients completed treatment with one patient having previously withdrawn her consent shortly after her initial clinical visit. More information about the clinical trial can be found on clinicaltrials.gov. The presentation, entitled “Oral Enobosarm Shows Promising Activity in Post-Menopausal Women with Stress Urinary Incontinence: Results of A Phase 2 Study”, can be found on the Company’s website.
About the Phase 2 ASTRID Clinical Trial
In addition to the Phase 2 proof-of-concept clinical trial that was
presented at SUFU, GTx also has a larger, ongoing, placebo-controlled
Phase 2 clinical trial in postmenopausal women with SUI. The study,
called ASTRID (Assessing Enobosarm for Stress Urinary Incontinence
Disorder), is currently recruiting women at over 60 clinical
trial centers across
About Enobosarm and SUI
Enobosarm, a selective androgen receptor modulator (SARM), has been evaluated in 25 completed or ongoing clinical trials. These clinical trials have enrolled over 1,700 subjects, of which approximately 1,200 subjects were treated with enobosarm at doses ranging from 0.1 mg to 100 mg, excluding the ASTRID clinical trial. At all evaluated dose levels, enobosarm was observed to be generally safe and well tolerated.
The rationale for evaluating enobosarm as a treatment for SUI is supported by preclinical in vivo data demonstrating increases in pelvic floor muscle mass following treatment with GTx’s SARM compounds, including enobosarm, and data from the Company’s ongoing Phase 2 proof-of-concept clinical trial continues to validate the use of enobosarm as a potential treatment for SUI.
About Stress and Urge Urinary Incontinence
Stress urinary incontinence (SUI) refers to the unintentional leakage of
urine during activities that increase abdominal pressure such as
coughing, sneezing or physical exercise. SUI, the most common type of
incontinence suffered by women, affects up to 35 percent of adult women
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon
GTx's current expectations. Forward-looking statements involve risks and
uncertainties, and include, but are not limited to, statements relating
to GTx's ongoing clinical development of enobosarm (GTx-024) for the
treatment of stress urinary incontinence (SUI). GTx's actual results and
the timing of events could differ materially from those anticipated in
such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the risks (i) that the
Phase 2 placebo-controlled clinical trial being conducted by GTx for the
treatment of SUI may not be completed on schedule; (ii) that additional
clinical development of enobosarm for the treatment of SUI will be
required beyond the two ongoing Phase 2 studies; and (iii) any future
development of enobosarm as a treatment for SUI is contingent on
obtaining sufficient additional capital to permit such development,
which it may be unable to do. In addition, GTx will continue to need
additional funding and may be unable to raise capital when needed, which
would force GTx to delay, reduce or eliminate its product candidate
development programs and potentially cease operations. GTx’s actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties. You should not place undue reliance on these
forward-looking statements, which apply only as of the date of this
press release. GTx’s quarterly report on Form 10-Q for the quarter ended