ANN ARBOR, Mich., July 29 QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company, today announced positive top-line efficacy results from the first of two patient cohorts in its second pivotal Phase 3 trial of the investigational compound, Ophena(TM) (ospemifene tablets), for the treatment of postmenopausal vulvovaginal atrophy (VVA). The Company has also successfully completed two long term safety extension studies from its first pivotal Phase 3 studies. QuatRx intends to use these results in support of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in early 2010 seeking approval for Ophena(TM), a new SERM (selective estrogen receptor modulator) for the treatment of the symptoms of vulvovaginal atrophy. Ophena(TM) is the only non-estrogen therapy currently in late-stage development for the treatment of vaginal symptoms associated with menopause.
"We are delighted with the progress in our Phase 3 program of Ophena(TM), which provides further evidence of the potential of Ophena(TM) as a first-in-class non-estrogen drug for the treatment of vaginal atrophy, a highly prevalent and symptomatic condition" said Robert L. Zerbe, M.D., Chief Executive Officer of QuatRx. "These new efficacy data confirm results seen in our first phase 3 pivotal study and are an important milestone towards our planned NDA submission."
This second Phase 3 study of Ophena(TM) is a randomized, double-blind, placebo-controlled trial of 919 patients with vulvovaginal atrophy conducted at 116 sites in the United States. Patients were stratified into two cohorts based on their most bothersome moderate to severe vaginal atrophy symptom - either vaginal dryness or dyspareunia (sexual pain). The results announced today focus on the cohort of 314 patients from this study identifying vaginal dryness as their most bothersome symptom. The positive efficacy results in this cohort, achieved in all four co-primary endpoints, confirm the results seen in the first pivotal Phase 3 trial of Ophena(TM). The results also demonstrate that Ophena(TM) was well-tolerated. A second cohort of the study, consisting of 605 patients with the most bothersome moderate to severe vaginal atrophy symptom of dyspareunia, is fully enrolled and will report out in late summer of this year.
The latest results showed statistically significant changes from baseline to week 12 compared to placebo in four co-primary endpoints: the percentages of both parabasal cells and superficial cells in the vaginal maturation index, changes in vaginal pH (all p<0.001) and improvements in the most bothersome symptom of vaginal dryness (p=0.01 on a per protocol analysis). All women were supplied with a non-hormonal vaginal lubricant to be applied as needed during the treatment period and the study results demonstrated efficacy above and beyond this lubricant usage, as also observed in the first Phase 3 study.
Phase 3 Long Term Safety Update
In January 2008, QuatRx announced positive results from its first pivotal Phase 3 trial of Ophena(TM). The Company has since completed two long term safety extensions from this first Phase 3 trial. Women who had undergone a hysterectomy were enrolled in an open label study of 60mg Ophena(TM) for an additional year of therapy. Women with an intact uterus were enrolled into an extension study where the treatment blind was maintained for a total of a year. In this study, 83% of women taking 60mg of Ophena(TM) completed the study, compared with 69% of women on placebo. The most frequently occurring treatment-emergent adverse event that was considered related to study drug was hot flush (7% in 60mg Ophena(TM) vs. 4% in placebo). Most treatment-emergent adverse events were mild or moderate in severity. No trends were apparent in severe treatment-emergent adverse events and no cases of pelvic organ prolapse, venous thromboembolism, endometrial hyperplasia or carcinoma were observed. Overall, the results of this double-blind, placebo-controlled, long-term safety extension study demonstrated that daily doses of 60mg Ophena(TM) are well-tolerated in the treatment of vulvovaginal atrophy.
A separate long-term safety study of Ophena(TM) is nearing completion. The results from this study, as well as additional efficacy data from the dyspareunia cohort of the second Phase 3 study, are expected in the third quarter.
About Postmenopausal Vaginal Atrophy
Postmenopausal vulvovaginal atrophy 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 postmenopausal women experience chronic symptoms of vaginal atrophy. 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 vaginal atrophy symptoms.
About QuatRx
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 clinical development and a 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 www.quatrx.com.
SOURCE QuatRx Pharmaceuticals Company
