SAN DIEGO, Nov. 8, 2018 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company") today
announced the last patient has completed her last visit in AMPOWER,
the second Phase 3 clinical trial of
Amphora® (L-lactic acid, citric acid and potassium
bitartrate), its lead Multipurpose Vaginal pH Regulator (MVP-R)
product candidate, for the prevention of pregnancy.
Amphora is an investigational, first-in-class MVP-R designed to
give a woman control over some of the most intimate issues of her
life and health. This non-hormonal, non-systemic vaginal gel is
being developed for woman-controlled birth control as well as
prevention of certain sexually transmitted infections (STIs).
"We have long recognized the need for well-studied birth control
options that will address the needs of women who do not wish to
become pregnant but will not or cannot use hormonal birth control
methods," said Bassem Maximos, MD,
MPH, FACOG, a practicing obstetrician/gynecologist and principal
investigator for AMPOWER. "An FDA-approved hormone-free birth
control product that is both on-demand and woman-controlled would
represent a new and important option in the gynecologist's arsenal,
unlike anything that is available
today."
"Widespread demand for participation in this important Phase 3
clinical trial allowed us to successfully enroll approximately
1,400 women, the last of whom has just completed her final study
visit. Achieving this critical milestone brings us another
step closer to moving forward with data analyses, keeping us on
track for top-line AMPOWER data by the end of this year," said
Brandi Howard, PhD, Evofem's Senior
Vice President of Global Clinical Development & Medical
Affairs.
"Assuming positive results, Evofem will re-submit the Amphora
New Drug Application in the second quarter of 2019," said
Saundra Pelletier, Chief Executive
Officer of Evofem Biosciences. "Subject to FDA approval, we expect
to commercialize Amphora in January
2020 as the first and only non-hormonal, woman-controlled
prescription birth control method in the U.S."
"We would like to thank our investigators and site coordinators,
as well as the patients who participated in this important study,
which will provide critical insight on the potential of Amphora as
a non-hormonal birth control method," Dr. Howard continued. "This
first-in-class product has the potential to be a paradigm-shifting
new option for millions of women in the U.S., including the 16.5
million women who do not wish to become pregnant and currently use
no form of birth control.1"
Women who do not use any contraceptive method but who are not
trying to become pregnant have an 85% risk of experiencing an
unintended pregnancy within one year.1
Pelletier continued, "Most women don't have sex every day, yet
the majority of available options require a daily dose of
hormones. It is time that women have access to a product
designed for them, that empowers them with a safe and effective
non-hormonal birth control option, that they use only when
needed."
About Amphora
Amphora® (L-lactic acid, citric acid, and potassium bitartrate) is
an investigational non-hormonal gel 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 expects top-line data in December
2018 from AMPOWER, its Phase 3 clinical trial evaluating
Amphora for the prevention of pregnancy. This single-arm,
open-label trial enrolled approximately 1,400 women aged 18-35 who
are at risk of pregnancy at 112 U.S. centers. The primary endpoint
of the study is pregnancy prevention over seven cycles of use.
The Company is actively enrolling AMPREVENCE, a double-blinded
placebo-controlled Phase 2b clinical trial of Amphora to
prevent urogenital acquisition of Chlamydia
trachomatis (primary endpoint) and Neisseria
gonorrhea (secondary endpoint) in women. This study
is designed to enroll 844 women at approximately 50 centers
in the United States for a four-month interventional
period and subsequent one-month follow-up period.
The CDC recently reported that rates of chlamydia, the most
frequently reported bacterial sexually transmitted disease (STD) in
the U.S., and gonorrhea have climbed for the fourth consecutive
year in the United States. Last year, nearly 2.3 million U.S.
cases of these STDs were diagnosed, according to preliminary data,
an increase of over 200,000 cases as compared with
2016.2 There are currently no FDA-approved products for
either of these STDs.
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 is leveraging its
proprietary Multipurpose Vaginal pH Regulator (MVP-R) to develop
product candidates for multiple indications, including prevention
of pregnancy, prevention of urogenital transmission of chlamydia
and gonorrhea in women and the prevention of recurrent bacterial
vaginosis. For more information regarding Evofem, please visit
www.evofem.com.
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; statements about
the anticipated results of the Phase 3 clinical trial evaluating
Amphora for birth control and the Phase 2b clinical trial of Amphora to prevent
urogenital acquisition of Chlamydia trachomatis and
Neisseria gonorrhea in women, and any expected completion
dates or general timing for these clinical trials. These statements
are often characterized by terminology such as "believes," "hope"
"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
Quarterly Report for the period ended March
31, 2018, as filed with the SEC on Form 10-Q on May 14, 2018, 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 publications and general publications and research,
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.
1NHS Data Brief #173, December
2014, "Current Contraceptive Status Among Women Aged 15-44"
(Based on National Survey of Family Growth data)
2Centers for Disease Control and Prevention (2018):
STD Preliminary Data Accessed August 2018.
Amphora® is a registered trademark of Evofem
Biosciences, Inc.
Investor Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
O: (858) 550-1900 x167
M: (917) 673-5775
Media Contact
Charlotte Wray
RXMD
evofem@rxmedyn.com
O: (646) 599-8601
M: (646) 247-3405
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SOURCE Evofem Biosciences, Inc.