Repros Therapeutics got a boost from its announcement that its late-stage testosterone treatment beat out the topical Androgel in helping patients with low testosterone, or hypogonadism.
Androgel performed particularly poorly in the study, beaten out by the placebo as well on one of the primary endpoints for sperm concentration. Repros ($RPRX) says its treatment, Androxal, also came out on top on the number of complete responders in the study. Repros shares had jumped 13% by mid-morning on Thursday after taking some twists and turns on the market.
Repros is shooting to add some luster to its label with this study, one of two comparing its therapy with a competing testosterone treatment. The Texas-based biotech had to delay its expected filing for the therapy after running into trouble with regulators at the FDA, who questioned their selection of patients in a pivotal study. Now the plan is to file in the fourth quarter, hoping to add some positive comparison results in the process.
"Multiple secondary endpoints also showed statistically significant differences between the Androxal and T gel groups," the biotech claimed. "These include: change in the important pituitary signaling hormones LH and FSH; percent of subjects that become severely oligospermic (< 10 million sperm/mL); induction of hormone dependence via assessment of morning testosterone levels comparing baseline to one week after the end of dosing; and impact on testicular size at the end of the dosing period."
Repros is also conducting a comparison study with a testosterone replacement treatment.
- here's the release