Is Memphis-based Biotech GTx About to Disrupt the Female Incontinence Market?

San Francisco, CA (UroToday.com) The Problem: Stress Urinary Incontinence (SUI) affects up to 50 percent of adult women. It’s the unintentional leakage of urine when coughing, sneezing or during physical exercise. There are no FDA-approved pharmaceutical therapies for SUI.

The Vision: GTx hopes that the highly-anticipated ASTRID Trial results this Fall will be similar to the proof-of-concept data unveiled a year ago in which:

• Mean stress leaks decreased by 81% from baseline over the 12-week treatment period
(reductions in stress leaks/day of ≥ 50%  from baseline are considered clinically significant)
• One-third of women continued to be essentially dry 7-months post-treatment

The Milestone: Early Q4 2018, GTx (NASDAQ:GTXI) plans to report results from a placebo-controlled clinical trial (the ASTRID Trial) to evaluate whether its drug (a daily pill called enobosarm) may be “kegels in a bottle”, as characterized early-on by principal investigator, Ken Peters, M.D., Chairman of Urology, Oakland University William Beaumont School of Medicine.

The ASTRID Trial: A Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm (3 mg or 1 mg) in 493 post-menopausal women with SUI. ASTRID is evaluating whether enobosarm, administered daily for 12 weeks, significantly improves stress leaks, compared to placebo.

Related Content:
Watch: “Kegels In A Bottle”: Preliminary Results Of A Selective Androgen Receptor Modulator For The Treatment Of SUI - Kenneth Peters

Watch: Enobosarm in Postmenopausal Women for Stress Urinary Incontinence - Interview with Kenneth Peters