Can GTx Make It Past This Enobosarm Study?
GTx Inc. (NASDAQ: GTXI) shares were absolutely crushed on Friday after the company announced results from its midstage trial in post-menopausal women with stress urinary incontinence.
Unfortunately, the Phase 2 trial of enobosarm did not achieve statistical significance on the primary endpoint of the proportion of patients with a greater than 50% reduction in incontinence episodes per day compared to the placebo.
In fact, the percentage of patients with a greater than 50% reduction after 12 weeks of enobosarm treatment was 58.9% for the 3 mg dose, 57.7% for the 1 mg dose and 52.7% for the placebo. Enobosarm was generally safe and well tolerated.
Executive Chair Robert J. Wills, Ph.D., commented:
We are very disappointed that the ASTRID Trial did not achieve its primary endpoint. We plan to conduct a full review of all the data. We want to thank the patients, physicians, study coordinators and the entire GTx team for their support of this novel study. We have an ongoing preclinical program assessing the potential of SARDs, our novel selective androgen receptor degrader technology, to treat castration-resistant prostate cancer. We are currently on target to have development candidates by year end, which we potentially plan to take into IND-enabling studies.
Excluding Friday’s move, GTx had actually outperformed the broad markets with its stock up 171% in the past 52 weeks. In just 2018 alone, the stock was up 83%.
Shares of GTx were last seen down 91% at $1.97, with a consensus analyst price target of $37.50 and a 52-week trading range of $1.91 to $25.60.