SAN DIEGO, Sept. 14, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM) today announced pivotal results
from the Phase 2b AMPREVENCE trial in
a poster presentation from the 2020
STD Prevention Virtual Conference, which will take place
online September 14 through 24.
AMPREVENCE evaluated the safety and efficacy of the Company's
investigational product candidate EVO100 for the prevention of
urogenital chlamydia and gonorrhea in women. The Phase 2b study met its primary and secondary endpoints,
with women receiving EVO100 experiencing a relative risk reduction
for chlamydia and gonorrhea infection of 50% and 78%, respectively,
compared to women receiving placebo. EVO100 was generally safe and
well tolerated by women participating in the study.
Positive, statistically significant data from the AMPREVENCE
study along with a recent data review from the FDA has positioned
Evofem to begin a Phase 3 clinical trial of EVO100 for prevention
of chlamydia and gonorrhea in women in the fourth quarter of
2020.
"EVO100 has the potential to impact the health of millions of
women by reducing infection rates of chlamydia and gonorrhea," said
Kelly Culwell, M.D., Evofem
Biosciences' Chief Medical Officer. "We recently had a productive
Type C meeting with the FDA that confirmed a very clear path
forward in our clinical development and we look forward to
initiating our Phase 3 clinical trial before the end of the
year."
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
treat.2
"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 poster author B. Todd Chappell, M.D., an AMPREVENCE investigator
and 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 an innovative option to help prevent the
acquisition of STIs."
2020 STD Prevention Virtual
Conference poster details are as follows:
- Title: Efficacy and Safety of a Novel Vaginal Ph Modulator for
Prevention of Chlamydia and Gonorrhea
- Authors: B. Todd Chappell, M.D.;
Scott Mollan, MS, MBA; Kelly Culwell, MD, MPH; Brandon Howard, PhD
- Poster Topic: Novel Methodologies & Techniques
- The poster is available for download on the conference
website
About the AMPREVENCE Trial
AMPREVENCE was 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
EVO100 vaginal gel 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 reduction in the incidence of urogenital Chlamydia
trachomatis and Neisseria gonorrhea, respectively. Fifty
centers in the United States
participated in this unprecedented trial.
About Evofem Biosciences,
Inc.
Evofem
Biosciences, Inc., (NASDAQ: EVFM) is a commercial-stage
biopharmaceutical company committed to developing and
commercializing innovative products to address unmet needs in
women's sexual and reproductive health, including hormone-free,
woman-controlled contraception and protection from certain sexually
transmitted infections (STIs). The Company's first commercial
product, Phexxi™ (lactic acid, citric acid and potassium
bitartrate), is the first and only hormone-free, prescription
vaginal gel approved in the United States for the
prevention of pregnancy. The Company is also advancing EVO100 into
a Phase 3 clinical trial for the prevention of urogenital
transmission of both Chlamydia
trachomatis and Neisseria gonorrhoeae in
women. For more information, please
visit www.evofem.com.
Phexxi™ is a trademark of Evofem Biosciences, Inc.
Forward-Looking Statements
This press release
includes "forward-looking statements," within the meaning of the
safe harbor for forward-looking statements provided by Section 21E
of the Securities Exchange Act of 1934, as amended; and the Private
Securities Litigation Reform Act of 1995, including, without
limitation, statements related to Evofem's expectations regarding
the success of the commercial launch of Phexxi, the success of the
Phexxi Concierge Experience, our ability to obtain coverage
under the ACA and the copay assistance program. Various factors
could cause actual results to differ materially from those
discussed or implied in the forward-looking statements, and you are
cautioned not to place undue reliance on these forward-looking
statements, which are current only as of the date of this press
release. Each of these forward-looking statements involves risks
and uncertainties. Important factors that could cause actual
results to differ materially from those discussed or implied in the
forward-looking statements, or that could impair the value of
Evofem Biosciences' assets and business, are disclosed in Evofem's
SEC filings, including its Annual Report on Form 10-K for the year
ended December 31, 2019 filed with
the SEC on March 12, 2020, its
Quarterly Report on Form 10-Q for the quarter ended March 31 filed with the SEC on May 6, 2020 and August 4,
2020, and its Current Report on Form 8-K filed with the SEC
on June 2, 2020. All forward-looking
statements are expressly qualified in their entirety by such
factors. Evofem does not undertake any duty to update any
forward-looking statement except as required by law.
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.
Media Contact
Becky Vonsiatsky
W2O
Bvonsiatsky@w2ogroup.com
Mobile: (413) 478-2003
Investor Relations Contact
Amy
Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Office: (858) 550-1900 x167
Mobile: (917) 673-5775
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SOURCE Evofem Biosciences, Inc.