Repros climbs on Phase 2 data
- Repros Therapeutics’ Proellex reduced endometriosis pain by 86% and cut use of pain medication by more than half, according to results released Wednesday from the first course of treatment in an ongoing Phase 2 trial.
- Repros now plans to talk to the FDA about late-stage development of Proellex, including future Phase 3 studies in women with painful menses.
- Company stock jumped sharply higher on release of the results, before settling to 15% over Wednesday's close in morning trading Thursday.
There is a need for a better treatment for endometriosis, which can cause debilitating pain and infertility. Current treatments include surgery and existing drugs treat symptoms rather than modify the disease. Existing therapeutics include gonadotropin-releasing hormone (GnRH) agonists, which can only be used short-term, or off-label use of contraceptives.
According to a report from BCC Research, the women’s health therapeutics market was worth around $33 billion in 2015, and the endometriosis market alone could be worth nearly $2.7 billion by 2020.
Repros Therapeutics’ Proellex (telapristone acetate), which is also in Phase 2 trials as a vaginal and oral treatment for uterine fibroids, acts by blocking the progesterone receptor.
There are also a few other companies in the field — for example, Bayer has a collaboration with Evotec, and a molecule from the program moved into Phase 1 earlier in 2016. Start-up ObsEva has a GnRH antagonist in Phase 2.
Repros Therapeutics has also developed enclomiphene, a small molecule awaiting approval in the U.S. to treat secondary hypogonadism, associated with obesity.
Repros’ share price hit a 52-week high of $8.96 late in 2015, but subsequently tumbled on news the FDA had canceled an advisory panel meeting set to review its NDA for enclomiphene, the company’s treatment for secondary hypogonadism.
- Repros Press Release
- BCC Research With No Cure, Endometriosis Is an Urgent Women's Health Issue
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