Repros Therapeutics
Inc.^® RPRX today provided a clinical update of its Androxal^® Phase
3 program.
1-Year DEXA Study
Critical path analysis showed that the DEXA study was key to an NDA
submission. The Company is pleased to announce that the one year DEXA study is
fully enrolled 3 months ahead of schedule. This key event should ensure the
submission of the Androxal NDA by mid-2014. The Company plans to continue
enrollment into the study to ensure that the FDA mandated long term safety
requirements for a minimum exposure of 800 subjects for 6 months are met.
Pivotal Studies ZA-301 and ZA-302
Study ZA-301 has been fully enrolled for several weeks now with 8% of the
subjects having completed the study. 3% of the subjects have dropped out
before the first visit post the start of dosing. 146 subjects (randomized 3:1
active:placebo) have reached the 6 week visit at which time up-titration was
allowed. 35% of the men in this blinded study have up-titrated. This is
consistent with the fact that 25% of the subjects are on placebo and
approximately 80% of men are projected to achieve normal testosterone levels
on the 12.5 mg dose.
There have been no SAE's resulting in withdrawal from the study.
Though only a few sperm counts have been analyzed, men that achieve higher
testosterone levels appear to exhibit increased sperm concentrations. This
would be consistent with Androxal's action, which results in increased
secretions of pituitary hormones that drive testicular function.
Men enrolled in the pivotal studies exhibit testosterone levels below 300
ng/dl on two separate days at baseline and record normal sperm counts on two
separate days, as well.
As in all Androxal studies, men must be overweight (BMI>25) and less than 60
years of age.
Study ZA-302 has enrolled 50 of the 152 subjects planned and the Company
expects to achieve full enrollment by the end of Q1 2013.
Six Month Open Label Study (ZA-300)
As part of the FDA requirement for total number of subjects to be exposed for
6 months (800), the Company is conducting a 500 subject open label study. To
date, the Company has enrolled 415 subjects and expects the study to be fully
enrolled by the end of Q1 2013.
332, 156 and 33 men have completed 6, 16 and the full 26 weeks of the study
respectively. 7% of the men have prematurely withdrawn from the study. There
have been no SAE's resulting in study withdrawal.
Approximately 83% of men in ZA-300 respond to Androxal exhibiting testosterone
levels above 300 ng/dL. Those men that respond in general maintain the levels
over the course of the 6 month study. As in the other studies, no men achieved
hormone levels above the normal range.
The only difference between ZA-300 and ZA-301/302 is that men could be current
testosterone replacement users in ZA-300 and be admitted into the study after
washout. Over one-third of the men in ZA-300 were using testosterone before
enrolling into the trial.
Overall Efficacy and Safety
The Company continues to believe Androxal offers a safer and more reliable
treatment for secondary hypogonadism than the currently approved hormone
replacement products. In all of the studies that have been conducted to date
there have been no serious adverse events attributed to the drug. This finding
is remarkable given the co-morbidities typically encountered with secondary
hypogonadism.
Oral administration, safe and consistent efficacy for over 80% of men and no
potential for abuse leads Repros to believe Androxal, if approved, will be the
drug of choice in treating secondary hypogonadism.
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