SAN DIEGO, Aug. 5, 2019 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM) (Evofem), a clinical-stage
biopharmaceutical company, today reported additional data from its
Phase 3 'AMPOWER' clinical trial of Amphora® for the prevention of
pregnancy. These findings reveal that the use of Amphora, a
first-in-class investigational Multipurpose Vaginal pH Regulator
(MVP-R™), may improve sexual satisfaction and have a positive
impact on women's sex lives. The analysis also confirmed
certain previously reported safety and efficacy data.
AMPOWER is the first clinical study to explore the effects of a
contraceptive product candidate on sexual satisfaction.
As part of a sexual satisfaction exploratory endpoint, study
participants were asked to answer survey questions (unvalidated
instrument) aimed at assessing the impact of their most recent
contraceptive method on their sex life at two time points: upon
entry into the study (baseline; n=1330) and after using Amphora for
one month (n=1118). At baseline, just 17% of study
participants reported their most recent contraception made their
sex life 'a little' or 'a lot' better than before. However,
after at least one cycle of Amphora use, 45% of women reported
their sex life was 'a little' or 'a lot' better.
"For the first time, we are investigating not only the clinical
benefits of a birth control method but also listening to women's
needs throughout their reproductive and sexual health journey,"
said Saundra Pelletier, CEO of
Evofem Biosciences. "These data, although preliminary, suggest that
use of Amphora increased the number of women reporting an improved
sex life compared with the contraceptive methods they used before
entering the AMPOWER study. If approved, we look forward to
launching Amphora in 2020 as the first MVP-R for hormone-free birth
control."
In addition, our third party data and statistics analyst has
completed its comprehensive review of the complete data set for our
AMPOWER trial, which confirms the favorable safety profile of this
first-in-class MVP-R product candidate. During AMPOWER, 1330 women
used Amphora and contributed 7561 cycles of safety data. The
incidence of serious adverse events (SAEs) was low (1.1%), and none
of the SAEs were considered definitely related to treatment with
Amphora. Most adverse events (AEs) were mild to moderate in
severity, and fewer than 2% of treated subjects discontinued
prematurely due to an AE. Pregnancy outcome and infant
assessments did not reveal any adverse pregnancy outcomes from
participation in the study.
Further, using the Kaplan-Meier statistical method, our third
party data and statistics analyst has also confirmed that the
cumulative pregnancy rate was 13.7% over seven cycles of use (95%
CI 9.9, 17.4), which corresponds to an 86.3% efficacy rate for
typical use and exceeds the pre-determined primary end point of the
AMPOWER trial. While conducting final data analysis, our
third party biostaticians identified an inconsistency in the
programming logic of their initial top-line assessment for women
who correctly used Amphora as directed (sometimes referred to as
perfect use). The recalculated cumulative pregnancy rate for
women who used Amphora according to the research protocol was 6.7%
over seven cycles of use [(95% CI 4.6, 8.7)], which corresponds to
a 93.3% efficacy rate. Perfect use is not considered an
endpoint of interest for FDA approval.
Additional data related to efficacy, safety and patient
satisfaction in the AMPOWER trial will be presented at three
clinical and medical society conferences in October 2019. Further data related to the AMPOWER
study's exploratory endpoint evaluating the impact of Amphora on
sexual satisfaction is targeted for presentation in 2020.
About AMPOWER
The Phase 3 'AMPOWER' clinical trial
assessed the effectiveness and safety of the investigational
product Amphora in preventing pregnancy over seven menstrual cycles
of use in approximately 1,330 women at 112 centers in the United States. Evofem's lead candidate
Amphora met the pre-specified primary endpoint of this trial, had a
favorable safety profile, and was well tolerated.
About Evofem Biosciences
Evofem Biosciences, Inc., is
a clinical-stage biopharmaceutical company committed to developing
and commercializing innovative products to address unmet needs in
women's sexual and reproductive health. The Company is leveraging
its proprietary Multipurpose Vaginal pH Regulator (MVP-R™) platform
to develop its first product candidate, Amphora® (L-lactic acid,
citric acid and potassium bitartrate). Amphora is an
investigational MVP-R designed to regulate vaginal pH within the
normal range of 3.5 to 4.5. This maintains an acidic environment
which is inhospitable to sperm as well as certain viral and
bacterial pathogens associated with sexually transmitted infections
but is integral to the survival of healthy bacteria in the
vagina.
Evofem plans to resubmit the Amphora New Drug Application (NDA)
for prevention of pregnancy and vaginal lubrication in the fourth
quarter of 2019. If approved, the Company plans to launch Amphora
in 2020 as the first-in-class MVP-R for hormone-free,
woman-controlled birth control.
This investigational MVP-R is also in development for prevention
of certain sexually transmitted infections. Evofem expects to
report top-line data from AMPREVENCE, the ongoing Phase
2b trial of Amphora to prevent
urogenital acquisition of Chlamydia trachomatis (primary
endpoint) and Neisseria gonorrhea (secondary endpoint) in
women, in the fourth quarter of 2019.
For more information, please visit www.evofem.com.
NOTE: Amphora® is a registered trademark and MVP-R™ is a
trademark of Evofem Biosciences, Inc.
Forward-Looking Statements
This press release contains
"forward-looking statements" within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including statements related to anticipated presentations at
upcoming medical society meetings, the timing of the planned
Amphora NDA re-submission for prevention of pregnancy, potential
FDA approval of Amphora, and the potential commercial launch of
Amphora. Each of these forward-looking statements involves
risks and uncertainties. Actual results may differ materially from
those, express or implied, in these forward-looking statements.
Important factors that could impair the value of Evofem
Biosciences' assets and business are disclosed in the risk factors
contained in its Annual Report on Form 10-K for the year ended
December 31, 2108 filed with the
Securities and Exchange Commission on March
1, 2109 and subsequent filings. All forward-looking
statements are expressly qualified in their entirety by such
factors. Evofem Biosciences does not undertake any duty to update
any forward-looking statement except as required by law.
Contacts For Evofem
Biosciences
|
Investor
Relations
|
Media
|
Amy
Raskopf
|
Greg
Jawski
|
Evofem Biosciences,
Inc.
|
Porter
Novelli
|
araskopf@evofem.com
|
Greg.jawski@porternovelli.com
|
M: (917)
673-5775
|
M: (917)
749-4964
|
|
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/evofem-biosciences-reports-additional-data-from-phase-3-ampower-study-of-amphora-for-hormone-free-birth-control-300896497.html
SOURCE Evofem Biosciences, Inc.