Urology Product Preview: Testosterone agent meets efficacy endpoint in phase III studies
Testosterone agent meets efficacy endpoint in phase III studies
Clarus Therapeutics, Inc. recently presented phase III clinical data from two studies that it says support the safety and efficacy of oral testosterone undecanoate (REXTORO) for testosterone replacement therapy in men with hypogonadism. Each trial differed in design, dose-titration algorithm, and duration. Each demonstrated T replacement, and with the revised dose-titration algorithm, the maximum serum T concentration was comparable to other T replacement therapies. The agent met the efficacy endpoint in both studies, said Clarus Therapeutics CEO Robert E. Dudley, PhD, in a press release. The studies were presented at the International Congress of Endocrinology and the Endocrine Society’s Annual Meeting and Expo in Chicago.
Repeat injection of BPH agent improves AUA Symptom Index Score
Nymox Pharmaceutical Corp. announced positive efficacy data from its phase III NX02-022 repeat injection study of NX-1207 for BPH. The company reported that analysis of symptomatic improvement from repeat injection over a 1- to 2-year period showed a mean improvement of 8.2 points in AUA BPH Symptom Index Score. Evaluation of safety data confirmed that NX-1207 reinjection treatment was well tolerated and did not impair sexual function. In addition, NX-1207 reinjection treatment has not shown any drug-related significant side effects, Nymox said in a press release.
FDA permits submission of license application for bladder cancer Tx
Bioniche Life Sciences Inc. has received written guidance from the FDA that permits the submission of a biological license application (BLA) for U.S. marketing approval of the company’s Mycobacterial Cell Wall-Nucleic Acid Complex sterile suspension for the treatment of patients with bacillus Calmette–Guérin-refractory high-grade nonmuscle-invasive bladder cancer. The permission was granted based on Bioniche’s existing clinical trial data set, the company said. In preparation for submitting the BLA, the company has engaged a global regulatory consulting firm that will help in the review and final submission of the BLA.
FDA proposes co-primary endpoints for testosterone agent trials
The FDA has provided additional guidance to Repros Therapeutics regarding primary endpoints for the studies of Androxal that the company is currently conducting. The studies are comparing Androxal to the leading approved testosterone gel and placebo. Androxal is being developed for men of reproductive age with low testosterone due to secondary hypogonadism. The FDA proposed three co-primary endpoints: percentage change from baseline in sperm concentration comparing Androxal to the leading U.S. testosterone replacement therapy; proportion of men obtaining a testosterone level in the normal range; and percentage of men who exhibit sperm ≥10 million/mL at the end of 16 weeks of dosing and testosterone in the normal range, comparing Androxal to a testosterone gel as well as comparing Androxal to placebo.