SAN DIEGO, Aug. 26, 2019 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company") today
announced the last patient has completed her last visit in
AMPREVENCE, the Phase 2b clinical
trial evaluating the Company's lead product candidate Amphora®, a
Multipurpose Vaginal pH Regulator (MVP-R™), for the prevention of
acquisition of chlamydia and gonorrhea in women (as primary and
secondary endpoints, respectively).
According to the CDC, rates of infection with Chlamydia
trachomatis and Neisseria gonorrhea climbed in 2017 for
the fourth consecutive year in the United States. Nearly 2.3
million domestic cases of these sexually transmitted infections
(STIs) were diagnosed in 2017 with chlamydia accounting for 1.7
million of these cases, making it the most frequently reported
bacterial STI1. Further, gonorrhea is increasingly
becoming antibiotic resistant, making it much harder, or sometimes
impossible, to treat2.
"It is hard to believe that with the extensive advances in
modern medicine, we continue to see a rise in the annual reported
number of chlamydia infections," said Saundra Pelletier, Chief Executive Officer at
Evofem Biosciences. "Assuming positive top-line results in November
of this year, we look forward to the continued clinical development
of Amphora for the prevention of acquisition of chlamydia in
mid-2020. If successful, Amphora could be the first new innovation
to address this growing STI, reducing the negative fertility
impacts associated with chlamydia."
"We are grateful to our investigators and site coordinators as
well as the 860 women who participated in this landmark
study. AMPREVENCE will provide critical insight on the
potential of Amphora for prevention of these bacterial infections,"
added Brandi Howard, PhD, Evofem's
Head of Medical Affairs.
AMPREVENCE, a double-blind, placebo-controlled, Phase
2b trial, enrolled 860 women who had
been treated for chlamydia or gonorrhea in the four months
preceding enrollment in the study. Subjects were randomized to
either Amphora or placebo vaginal gel treatment arms. During the
four months the women participated in the study, they were asked to
apply the product candidate prior to each act of vaginal sexual
intercourse. The primary and secondary endpoints of the study are
the prevention of acquisition of urogenital Chlamydia
trachomatis and Neisseria gonorrhea,
respectively. Fifty U.S. centers participated 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. 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 has
the potential to maintain an acidic environment that is
inhospitable to sperm as well as certain viral and bacterial
pathogens associated with STIs 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 STIs. 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 November of 2019. For more
information, please visit www.evofem.com.
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 the
timing of the planned Amphora re-submission of the Amphora NDA for
prevention of pregnancy, potential FDA approval of Amphora, and the
potential commercial launch of Amphora, 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 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, 2018 filed with
the Securities and Exchange Commission on March 1, 2019 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.
2 Centers for Disease Control and Prevention (2018):
Antibiotic-Resistant Gonorrhea Basic Information.
Investor
Contact
|
Media
Contact
|
Amy
Raskopf
|
Greg
Jawski
|
Evofem Biosciences,
Inc.
|
Porter
Novelli
|
araskopf@evofem.com
|
Greg.jawski@porternovelli.com
|
C: (917)
673-5775
|
M: (917)
749-4964
|
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SOURCE Evofem Biosciences, Inc.