SAN DIEGO, Sept. 21, 2018 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"), a
clinical-stage biopharmaceutical company committed to developing
and commercializing innovative products to address unmet needs in
women's sexual and reproductive health, announced today that new
data from two clinical trials of Amphora®, its lead Multipurpose
Vaginal pH Regulator (MVP-R) product candidate, will be presented
at the 2018 American Society for Reproductive Medicine (ASRM)
Annual Congress taking place in Denver,
Colorado on October 9,
2018.
The two oral presentations will discuss new data from a
previously completed Phase 3 clinical trial (AMP001) on Amphora's
patient acceptability and assessment of genitourinary discomfort
compared to nonoxynol-9 and outcomes of a Phase 1 clinical trial
that evaluated Amphora's ability to alter vaginal pH, which
underlies the potential of Evofem's MVP-R product candidates for
birth control, for prevention of certain sexually transmitted
infections (STIs), and to reduce the recurrence of bacterial
vaginosis (BV).
Presentation details are as follows:
Abstract Title: Post Hoc Analysis of a Randomized
Placebo-controlled Pilot Study on the Effect of Amphora®, an
Acid-buffering Vaginal Gel, on Vaginal pH by Baseline Vaginal pH
Level
- Abstract Number: 52067
- Date/Time: Tuesday, October 9,
2018, 11:30 AM – 11:45 AM MT
- Presenter(s): John McLeod
Griffiss, MD
Abstract Title: Product Acceptability and Assessment of
Genitourinary Discomfort in a Phase 3 Trial Comparing an
Acid-Buffering Contraceptive Vaginal Gel (Amphora) To
Nonoxynol-9
- Abstract Number: 52054
- Date/Time: Tuesday, October 9,
2018, 11:45 AM – 12:00 PM MT
- Presenter(s): Brandi
Howard, PhD
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 even in the presence of semen. 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.
Top line data are expected by year-end 2018 from Evofem's
single-arm, open-label Phase 3 clinical trial (AMP002) evaluating
Amphora for the prevention of pregnancy. AMP002 enrolled
approximately 1,400 women aged 18-35 who are at risk of pregnancy
at 112 centers in the United
States; enrollment was complete in February 2018. The primary endpoint of this study
is pregnancy prevention over seven cycles of use. Assuming positive
results, the Company plans to re-submit the Amphora New Drug
Application (NDA) in the second quarter of 2019. If approved by the
FDA, Evofem will commercialize Amphora in early 2020 as the first
and only hormone-free, on-demand, woman-controlled birth control
method.
The Company is actively enrolling a Phase 2b double-blinded placebo-controlled clinical
trial (AMPREVENCE) 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 syphilis, gonorrhea and
chlamydia 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
2016.1
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's pipeline includes two proprietary Multipurpose Vaginal pH
Regulator (MVP-R) product candidates. The Company expects to report
top-line Phase 3 data on its lead MVP-R drug candidate, Amphora®,
for prevention of pregnancy by year-end 2018. 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 are often characterized by terminology such
as "believes," "hopes," "may," "anticipates," "should," "intends,"
"plans," "will," "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: objectives, plans and strategies as well as
statements, other than historical facts, that address activities,
events or developments that the Company intends, expects, projects,
believes or anticipates will or may occur in the future; risks and
uncertainties associated with market conditions; statements about
the anticipated results of the Phase 3 clinical trial evaluating
Amphora as a contraceptive 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; 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 which was obtained from sources believed to be
reliable, although they do not guarantee the accuracy or
completeness of such information. We have not independently
verified market and industry data from any third-party sources.
1Centers 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
Media Contact
Sophia
Ononye
RXMD
evofem@rxmedyn.com
O: (646) 599-8630
M: (917) 557-1909
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SOURCE Evofem Biosciences, Inc.