GTX Inc (NASDAQ:GTXI) issued financial report for the third quarter of 2017 and showcased upcoming milestones and recent accomplishments. Robert J. Wills, Ph.D., the Executive Chairman, expressed that during the quarter, they recorded a major milestone for the firm when they posted positive data from their first clinical study in stress urinary incontinence.
The update
Notably, 18 out of 18 subjects who received enobosarm for 12-weeks responded. Also, these responses seem to be durable, lasting months’ post dosing. These thrilling results offered the basis for their recently started, placebo-controlled clinical study of enobosarm for the cure of SUI. Kenneth M. Peters, M.D., the principal investigator in the study, expressed that recent data indicates 50% of women report stress urinary incontinence, for which there exist no FDA-permitted pharmaceutical treatments.
An orally-available treatment would provide numerous benefits over current treatments including surgery. They would offer a significant new alternative that several women would select in order to resolve this medical problem.
Enobosarm, a SARM, is being assessed in Phase II clinical advancement for stress urinary incontinence, GTX’s lead indication. The company posted positive data from the Phase II proof-of-concept clinical study of enobosarm 3 mg given orally in post-menopausal women with Stress Urinary Incontinence. With the addition of the final subject completing treatment in the clinical study, results from the 18 evaluable subjects completing the needed 12-weeks of daily treatment demonstrated a clinically meaningful decline in stress leaks a day, versus baseline. The mean drop in stress leaks a day was 81% overall.
GTX reported that subjects are being followed for another 28-weeks post-treatment to evaluate the durability of treatment effect. Response durability for subjects who completed the 28-week observation stage has led in a 41% to 100% decline in stress leaks per day from baseline. For those subjects who have not completed this phase, the response durability, measured starting four weeks after dosing, was sustained.
