SAN DIEGO, Dec. 2, 2019 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM), a clinical stage
biopharmaceutical company, today announced positive top-line
results from AMPREVENCE, a Phase 2b
clinical trial evaluating the efficacy and safety of its lead
product candidate Amphora® for the prevention of urogenital
chlamydia and gonorrhea in women. The study met both its primary
and secondary endpoints of reducing the risk of chlamydia and
gonorrhea infection, respectively, and demonstrated that Amphora
was generally safe and well tolerated.
In this landmark study, the infection rate of chlamydia among
women who used Amphora for the four-month study period was 4.9%
(n=14/288) compared to 9.8% among those who used placebo for four
months (n=28/287) (p=.024), a relative risk reduction of 50% in the
primary endpoint.
Among the reported cases of gonorrhea infection, the infection
rate was 0.7% in the Amphora arm (n=2/280), compared to 3.2% in the
placebo arm (n=9/277) (p=.03), a relative risk reduction of 78% in
the secondary endpoint.
Amphora was generally safe and well tolerated in this study
population, consistent with previous trial results for use of this
investigational drug for pregnancy prevention. The number of
adverse events was similar across both arms (7.2% for Amphora and
7.5% for placebo) and no serious treatment-related adverse events
were reported.
"In less than one week, we have achieved two major milestones
that have the potential to meaningfully impact the sexual and
reproductive health of millions of women," said Saundra Pelletier, Evofem Biosciences' Chief
Executive Officer. "In addition to resubmitting our New Drug
Application to the U.S. FDA for Amphora for prevention of
pregnancy, we also now have statistically significant evidence that
Amphora can prevent acquisition of chlamydia and gonorrhea among
women, two bacterial infections that are increasing at an alarming
annual rate in the U.S."
According to the U.S. Centers for Disease Control and Prevention
(CDC), rates of infection for Chlamydia
trachomatis and Neisseria
gonorrhea climbed in 2018 for the fifth consecutive year
in the United States. Nearly 2.4 million domestic cases of
these sexually transmitted infections (STIs) were diagnosed in
2018, with 1.8 million newly reported chlamydia cases and
approximately 580,000 newly reported gonorrhea cases.1
The CDC also reported that gonorrhea is increasingly becoming
antibiotic resistant, making it much harder, or sometimes
impossible, to treat2.
"Chlamydia and gonorrhea are both urgent public health issues
with significant consequences, and the emergence of drug-resistant
gonorrhea demonstrates that treatment alone is not going to curb
this growing epidemic," said B. Todd
Chappell, M.D., an AMPREVENCE investigator and an
obstetrician/gynecologist practicing at Adams Patterson Gynecology &
Obstetrics in Memphis,
Tennessee. "I am very encouraged by the results of the
AMPREVENCE trial and the notion that, in the future, we may be able
to provide women with a preventative option for pregnancy that may
also help prevent the acquisition of STIs."
"The AMPREVENCE trial demonstrated both robust efficacy and
safety, and achieved statistical significance for both its primary
and secondary endpoints – a substantial outcome for what we believe
is an unprecedented trial with no prior benchmark," said
Kelly Culwell, M.D., Evofem
Biosciences' Chief Medical Officer. "These data are even more
compelling when you consider that there are no approved
prescription therapies available to prevent infection with either
chlamydia or gonorrhea in women. If confirmed in subsequent
trials and approved by the U.S. Food and Drug Administration,
Amphora could be the first new female-controlled intervention with
the potential to address two significant unmet needs – non-hormonal
prevention of pregnancy and prevention of chlamydia and gonorrhea
infection."
Top-line results are based on a preliminary analysis of
currently available efficacy and safety data. Further analysis is
ongoing and final results are subject to change based on a
comprehensive review by the Company and the U.S. FDA. The Company
expects to submit full results for presentation at an upcoming
scientific meeting. These data will also form the basis for
an End-of-Phase 2 meeting request with the U.S. FDA.
Conference Call Details
The Evofem management team will host a conference call to
discuss the top-line AMPREVENCE results as follows:
Date
|
Monday, December 2,
2019
|
Time
|
8:30 a.m.
EST
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
1062588
|
Webcast (live and
archived)
|
www.evofem.com under
Investors
|
The live webcast and related slide presentation can be accessed
on the Company's Investor page
at https://evofem.investorroom.com/events. Please connect to
the Company's website at least 15 minutes prior to the start of the
call to download any software that may be required. If
participating by phone, please dial in approximately 10 minutes
prior to the start of the call.
A telephone replay will be available approximately two hours
after the call through Friday, December 6, 2019 at (855)
859-2056 (U.S.) or (404) 537-3406 (International), access code
1062588. The webcast will be archived at
https://evofem.investorroom.com/events.
About the AMPREVENCE Trial
AMPREVENCE is a
double-blinded, placebo-controlled Phase 2b clinical trial that enrolled 860 women who had
been treated for chlamydia or gonorrhea in the four months prior to
enrolling in the study. Subjects were randomized to receive either
Amphora® or placebo vaginal gel. During the four months the women
participated in the study, they were asked to apply the product
candidate or placebo prior to each act of vaginal sexual
intercourse. The primary and secondary endpoints of the study were
the prevention of acquisition of urogenital Chlamydia
trachomatis and Neisseria gonorrhea,
respectively. Fifty centers in the
United States participated in this unprecedented trial.
About Evofem Biosciences
Evofem Biosciences, Inc.,
(NASDAQ: EVFM) is a clinical-stage biopharmaceutical company
committed to developing and commercializing innovative products to
address unmet needs in women's sexual and reproductive health.
Evofem Biosciences aims to advance the lives of women by developing
innovative solutions, such as woman-controlled contraception and
potential protection from certain sexually transmitted infections
(STIs). The Company's lead Multipurpose Vaginal pH Regulator
(MVP-R™) product candidate, Amphora® (L-lactic acid, citric acid
and potassium bitartrate), is in development for multiple potential
indications: prevention of pregnancy, prevention of urogenital
transmission of Chlamydia trachomatis infection
(chlamydia) in women and prevention of urogenital transmission
of Neisseria gonorrhoeae infection (gonorrhea) in
women. For more information regarding Evofem, please visit
www.evofem.com.
Amphora® is a registered trademark and MVP-R™ is a trademark of
Evofem Biosciences, Inc.
Forward-Looking Statements
Statements in this press
release about Evofem's future expectations, plans and prospects, as
well as any other statements regarding matters that are not
historical facts, may constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. These statements, include, but are not limited to, statements
regarding objectives, plans and strategies that address activities,
events or developments that the Company intends, expects, projects,
believes or anticipates will or may occur in the future, including,
without limitation, statements related to the future potential
development of Amphora to prevent urogenital acquisition
of Chlamydia trachomatis and Neisseria
gonorrhea in women, and the potential FDA approval of
Amphora for prevention of pregnancy. These statements are often
characterized by terminology such as "believes," "hopes," "may,"
"anticipates," "should," "intends," "plans," "will," "could,"
"would," "expects," "estimates," "projects," "positioned,"
"strategy" and similar expressions and are based on assumptions and
assessments made in light of management's experience and perception
of historical trends, current conditions, expected future
developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties, many of which are
outside of the Company's control. Important factors that could
cause actual results, developments, and business decisions to
differ materially from forward-looking statements are described in
the sections titled "Risk Factors" in the Company's filings with
the Securities and Exchange Commission (SEC), including its Annual
Report on Form 10-K and subsequent filings, and include but are not
limited to the following: the Company's ability to raise the
additional funds necessary to commercialize Amphora as a
contraceptive and/or to complete the development of Amphora to
prevent urogenital acquisition of Chlamydia trachomatis and
Neisseria gonorrhea in women; the Company's reliance on third
parties to conduct its clinical trials, research and development
and manufacturing; the availability of reimbursement from
government authorities and health insurance companies for the
Company's products; the impact of potential product liability
lawsuits; the influence of extensive and costly government
regulation; the volatility of the trading price of the Company's
common stock, and the concentration of power in its stock
ownership. Forward-looking statements in this press release are
made as of the date of this press release, and the Company
undertakes no duty to update or revise any such statements, whether
as a result of new information, future events or otherwise. These
forward-looking statements should not be relied upon as
representing Evofem's views as of any date subsequent to the date
hereof. We have included certain information from government and
general publications and research, as well as surveys and studies
conducted by third parties. This information has been obtained from
sources believed to be reliable, although they do not guaranty the
accuracy or completeness of such information. We have not
independently verified market and industry data from any
third-party sources.
References
1 Centers for Disease
Control and Prevention (2019): 2018 STD Surveillance
Report.
2 Centers for Disease Control and Prevention
(2018): Antibiotic-Resistant Gonorrhea Basic Information.
Investor Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
M: (917) 673-5775
Media Contact
Cara Miller
Evofem Biosciences, Inc.
cmiller@evofem.com
O: (858) 550-1900 x272
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SOURCE Evofem Biosciences, Inc.