SAN DIEGO, April 23, 2019 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM) ("Evofem"), a clinical stage
biopharmaceutical company, today announced the completion of
patient enrollment in AMPREVENCE, the Phase 2b clinical trial evaluating its lead product
candidate Amphora®, a Multipurpose Vaginal pH Regulator™
(MVP-R), for the prevention of chlamydia and gonorrhea in
women.
According to the CDC, chlamydia is the most frequently reported
sexually transmitted bacterial infection in the U.S. Rates of
both gonorrhea and chlamydia climbed for the fourth consecutive
year, with over 2.2 million cases reported in 2017.1
"We are eager to gain further insight into the ability of
Amphora to prevent chlamydia and gonorrhea, and expect to report
top-line AMPREVENCE data by the end of this year," said
Saundra Pelletier, CEO of Evofem
Biosciences.
AMPREVENCE, a double-blinded, placebo-controlled Phase
2b trial, enrolled approximately 850
women who had been treated for chlamydia or gonorrhea in the
preceding four months. Subjects have been randomized to either
Amphora or placebo vaginal gel treatment arms where they were asked
to apply the study drug before engaging in sexual intercourse for
four months. The primary and secondary endpoints of the study are
the prevention of acquisition of urogenital Chlamydia
trachomatis and Neisseria gonorrhea,
respectively. Over 50 United States centers are
participating in this unprecedented trial.
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. 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 is leveraging
its proprietary Multipurpose Vaginal pH Regulator™ (MVP-R) platform
to develop Amphora® (L-lactic acid, citric acid and
potassium bitartrate) for birth control and prevention of
urogenital acquisition of certain STIs.
Amphora is 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. For
more information, please visit www.evofem.com.
Amphora® is a registered trademark and Multipurpose
Vaginal pH Regulator™ 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 the
anticipated results of the Phase 2b
clinical trial of Amphora to prevent urogenital acquisition of
Chlamydia trachomatis and Neisseria gonorrhea in
women, and any expected completion date or general timing for this
clinical trial. 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 the Evofem
Biosciences' assets and business are disclosed in the risk factors
contained in its Annual Report on Form 10-K filed with
the Securities and Exchange Commission 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.
References
1 Centers for Disease Control and Prevention (2018):
2017 STD Surveillance Report,
accessed April 18, 2019.
Contact
Investor Relations
Amy Raskopf
Evofem Biosciences
araskopf@evofem.com
M: (917) 673-5775
Media
Greg Jawski
Porter Novelli
Greg.jawski@porternovelli.com
M: (917) 749-4964
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SOURCE Evofem Biosciences, Inc.