GTX’s value leaks away with incontinence failure
Relying on uncontrolled trials is a risky business. GTX has demonstrated this again with failure in the first placebo-controlled study of its stress urinary incontinence candidate enobosarm. This looks like the end for the project and the company, too: after enobosarm, GTX’s most advanced assets are preclinical selective androgen receptor degraders for prostate cancer, and the group only had $46m at the last count. GTX’s stock plunged 91% this morning, wiping out gains seen since the company reported positive data from its uncontrolled proof-of-concept trial a year ago. Today’s result from the Astrid trial demonstrates why including a placebo group is so important: 53% of patients in the control arm achieved the primary endpoint, a 50% reduction in stress incontinence episodes at 12 weeks, versus a 60% and 58% response in the 3mg and 1mg enobosarm arms respectively. This is not much of a consolation for patients with stress urinary incontinence, whose only options are pads, pelvic floor exercises and surgery. The enobosarm failure means that this is unlikely to change for a long time – Stifel analysts noted that the project was the only one in development for the disorder, which affects around one third of postmenopausal women.