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.
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.