Pivotal Study Seeks to Enroll 750 Women at More Than 100 Sites in the U.S.
ANN ARBOR, Mich., Sept. 4 /PRNewswire/ -- QuatRx Pharmaceuticals, a privately-held biopharmaceutical company focused on development and commercialization of compounds to treat endocrine, metabolic and cardiovascular disorders, today announced that it has initiated a second Phase 3 clinical trial of Ophena(TM) (ospemifene tablets), the company's estrogen-free oral therapy in development for the treatment of vaginal symptoms associated with menopause.
The study is the second pivotal Phase 3 clinical trial for Ophena(TM), a new selective estrogen receptor modulator (SERM) for the treatment of postmenopausal vaginal syndrome (PVS), a common condition in postmenopausal women. PVS, also known as vaginal atrophy, is characterized by progressive long-term vaginal symptoms such as dryness, irritation and sexual pain (dyspareunia). The first Phase 3 trial for Ophena(TM) met all the co-primary endpoints at a 60 mg dosage, with statistically significant improvements in vaginal dryness and dyspareunia, as well as statistically significant improvement in the proportion of parabasal and superficial cells in the epithelium of vaginal walls and a decline in vaginal pH levels.
The randomized, double-blind study will seek to enroll 750 post-menopausal women at more than 100 trial centers throughout the United States. Women participating in the study will be treated with either a 60 mg once daily oral dose of Ophena(TM) or placebo over the 12-week treatment period. All women will also be supplied with a non-hormonal vaginal lubricant to be applied as needed during the treatment period.
The co-primary endpoints of the study are the change from baseline to week 12 in the percentage of parabasal cells in the vaginal maturation index, the percentage of superficial cells in the vaginal maturation index, vaginal pH, and improvements in the most bothersome moderate to severe vulvovaginal atrophy symptoms of vaginal dryness and dyspareunia.
"We were very pleased with the results of the first Phase 3 trial for Ophena(TM) and believe this next pivotal study will represent another significant development milestone for QuatRx," said Robert L. Zerbe, M.D., chief executive officer and president of QuatRx. "For the large population of postmenopausal women affected by progressive and bothersome vaginal symptoms, and especially those concerned about the health risks associated with long-term estrogen-based therapy, we believe Ophena(TM) has the potential to be an important new treatment option."
About Postmenopausal Vaginal Syndrome
Postmenopausal vaginal syndrome (PVS) is a chronic and progressive condition characterized by symptoms including vaginal dryness, sexual pain (dyspareunia) and irritation. Declining estrogen levels during menopause can cause tissues of the vaginal lining to grow thinner and to lose elasticity, a condition known as atrophy. Dryness and irritation associated with reductions in vaginal secretions often cause pain or bleeding during sexual intercourse. It is estimated that 45-75 percent of post-menopausal women experience chronic symptoms of PVS. Current prescription treatments approved for this condition all contain estrogen, administered either orally or locally in the vagina. SERMs that are currently approved and marketed in the United States have not been shown to have beneficial effects on vaginal tissue and none are approved for use in treating symptoms of PVS.
QuatRx Pharmaceuticals is focused on the discovery, licensing, development and commercialization of compounds in the endocrine, metabolic and cardiovascular therapeutic areas. In addition to Ophena(TM), QuatRx has three other product candidates in active clinical development and an advanced preclinical program. Fispemifene is a new selective estrogen receptor antagonist that is in Phase 2 studies as an oral treatment for the symptoms of secondary hypogonadism in men. Sobetirome, a novel, selective thyroid receptor beta agonist, is in Phase 1 as a potential treatment for dyslipidemia. Becocalcidiol, a novel Vitamin D analogue, is in Phase 2 clinical trials for the treatment of psoriasis through QuatRx's partner, Galderma. QuatRx's preclinical program is designed to address sex steroid dependent diseases through inhibition of 17beta-HSD enzymes. In Europe, QuatRx operates through its Finnish subsidiary, Hormos Medical Ltd, located in Turku, Finland. For press releases and other Company information, please visit http://www.quatrx.com.
|SOURCE QuatRx Pharmaceuticals|
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