QuatRx Announces Further Positive Phase 3 Results For Ophena (Ospemifene Tablets) in Postmenopausal Vaginal Atrophy
Safety and Efficacy Data Support Planned NDA Filing in Early 2010
ANN ARBOR, Mich., July 29 /PRNewswire/ -- 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
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
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
CONTACT: Julia Owens, +1-734-913-9900 x121
Web Site: http://www.quatrx.com
Posted: July 2009