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GTx Provides Corporate Update and Reports Fourth Quarter and Full Year 2017 Financial Results
-- Enobosarm for Stress Urinary Incontinence (SUI) continues to show sustained durability of response in Phase 2 proof of concept clinical trial --
-- Top-line results from the ASTRID trial, a Phase 2 placebo-controlled clinical trial of enobosarm for the treatment of SUI, are expected in the second half of 2018 --
“2017 was a transformational year for GTx, marked by positive results
from our Phase 2 proof-of-concept clinical trial in post-menopausal
women with stress urinary incontinence and the initiation of the ASTRID
trial, a Phase 2 placebo-controlled clinical trial of enobosarm for the
treatment of SUI,” said
Clinical Highlights and Anticipated Milestones
Stress Urinary Incontinence (SUI) Phase 2 Proof-of-Concept Trial:
Last week at the
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.
Additional positive results in subset of postmenopausal women suggest dual treatment effect on both urge incontinence and stress urinary incontinence.
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, also known as mixed incontinence.
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.
There were no serious adverse events reported during the trial 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.
SUI Phase 2 Placebo-Controlled ASTRID Clinical Trial:
Based on the positive results from the Phase 2 POC trial, the Company initiated a randomized, double-blinded, placebo-controlled, Phase 2 trial to assess the efficacy and safety of enobosarm administered orally in approximately 400 post-menopausal women with SUI compared to placebo. More information about the ASTRID (Assessing Enobosarm for Stress Urinary Incontinence Disorder) trial, which is ongoing, can be found here. Top-line results from the Phase 2 placebo-controlled clinical trial are expected in the second half of 2018.
The Company has a Selective Androgen Receptor Degrader (SARD) preclinical program to evaluate its novel SARD technology in castration-resistant prostate cancer (CRPC). The Company has ongoing mechanistic preclinical studies designed to select the most appropriate compound to potentially advance into a first-in-human clinical trial.
Fourth Quarter and Year-End 2017 Financial Results
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 the enrollment and conduct of GTx’s ongoing Phase 2
placebo-controlled clinical trial of enobosarm (GTx-024) in
post-menopausal women with stress urinary incontinence (SUI), as well as
GTx’s plans for its ongoing preclinical research and potential future
development of GTx’s licensed selective androgen receptor degrader
(SARD) technology, and the timing thereof; and the potential therapeutic
applications for, and potential benefits of SARM (including enobosarm)
and SARD technology. 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 GTx’s evaluation of its licensed
SARD technology is at a very early stage and it is possible that GTx may
determine not to move forward with any meaningful development of the
program; (ii) that if GTx determines to move forward with additional
development of enobosarm for the treatment of SUI or if GTx does
determine to move forward with development of its SARD program, GTx will
require additional funding, which it may be unable to raise, in which
case, GTx may fail to realize the anticipated benefits from its SARM
and/or SARD technology; (iii) that GTx may not be successful in
developing a clinical SARD product candidate to advance into clinical
studies or the clinical product candidate may fail such clinical
studies; (iv) that the Phase 2 placebo-controlled clinical trial of
enobosarm to treat SUI being conducted by GTx may not be completed on
schedule, or at all, or may otherwise be suspended or terminated; (v)
related to the difficulty and uncertainty of pharmaceutical product
development, including the time and expense required to conduct
preclinical and clinical trials and analyze data, and the uncertainty of
preclinical and clinical success; and (vi) related to issues arising
during the uncertain and time-consuming regulatory process, including
the risk that GTx may not receive any approvals to advance the clinical
development of one or more potential clinical SARM or SARD candidates.
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 annual
report on Form 10-K for the year ending