Shares of Repros Therapeutics ($RPRX) rocketed up 78% this morning after the Texas-based biotech announced that its roller-coaster ride in a short Phase III study for its experimental testosterone-boosting therapy Androxal ended on a positive note for a pair of co-primary endpoints.
The volatile Repros had badly rattled its investors earlier in the year when investigators opted to change trial strategies in Phase III. Investigators were alarmed to find that an outlier site including a large number of the patients with secondary hypogonadism were responding too well. Concerned that the bulge of data would arouse regulators' suspicions and raise doubts about the data, the biotech had begun to rearrange enrollment, adding patients from a second Phase III. But the FDA came up with a mutually satisfactory way to analyze the data, according to Repros, which put the study back on track and calmed shareholders.
A total of 79% of the intent-to-treat Androxal subjects demonstrated 24-hour average testosterone levels in the normal range, meeting a primary endpoint of 75% or better. A co-primary sperm count endpoint of noninferiority to placebo was also hit. And the company trumpeted the data as a sign that another Phase III now enrolling patients will also come in positive, laying the groundwork for an approval.
"As we expect full enrollment in the sister pivotal study ZA-302 by the end of May, today's outcome encourages us that a similar outcome will be realized," said Repros CEO Joseph S. Podolski. "The apparent increase in awareness of the urology community in the need for a more rational approach to the treatment of secondary hypogonadism compared to current testosterone gel products, as evidenced by the schedule of podium sessions at the upcoming AUA meeting, leads us to believe that Androxal, if approved, will become an important therapy in the treatment of this rapidly growing medical indication."
- here's the press release