Repros' Proellex Stays On Partial Clinical Hold, Shares Fall
Zacks Investment Research | Jul 18, 2017 05:50AM ET
Repros Therapeutics Inc. (NASDAQ:RPRX) announced that it received preliminary feedback from the FDA on its clinical development program for Proellex to treat uterine fibroids by oral mechanism. Per the FDA’s review, Proellex will remain on partial clinical hold and the company will be required to accumulate a large pre-approval safety data base in order for the candidate to be evaluated further. To meet the FDA’s requirement, the company will be required to conduct a much larger clinical study which will be time consuming and also expensive.
The shares of the company plunged about 34% on Monday after the news was announced. We note that Repros' shares have underperformed the Zacks classified Medical - Biomedical and Genetics industry in the last year. The stock has declined 70.8% as against the industry’s gain of 8.7% in the same period.
We remind investors that Proellex studies on oral dose for the treatment of endometriosis and uterine fibroids were placed under clinical hold in 2009. But later the FDA allowed the studies to be conducted under partial clinical hold with low oral dosage.
We note that the company is also evaluating Proellex, a selective progesterone modulator (SPRM), in a phase IIb study for uterine fibroids by vaginal delivery. However, this study has no clinical hold issues. The company said that it will now increase its focus on this study. The company presented positive top line data from this study in November last year.
Meanwhile, Repros also mentioned that it received a notice that on Aug 2, 2017 it will be granted a European patent relating to the use of SPRMs, in particular Proellex, with an Off Drug Interval (ODI) for the treatment of estrogen-dependent hyperproliferative uterine conditions, such as uterine fibroids and endometriosis.
Notably, Repros' other key pipeline candidate, enclomiphene, is being evaluated for the treatment of low testosterone level in overweight men. The company submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for enclomiphene ifor secondary hypogonadism in Europe in Sep 2016.
There are other companies that have been evaluating candidates for uterine fibroids. In Apr 2017, AbbVie Inc. (NYSE:ABBV) along with Neurocrine Biosciencesis also evaluating elagolix for reducing heavy menstrual bleeding in premenopausal women with uterine fibroids which is in mid-stage studies. Another company, Bayer Aktiengesellschaft (OTC:BAYRY) is evaluating vilaprisan in women suffering from uterine fibroids, which is in late stage studies.
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