SAN DIEGO, Oct. 20, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) today announced enrollment of the
first patient in its pivotal Phase 3 clinical trial evaluating
the safety and efficacy of EVO100 for the prevention of urogenital
chlamydia and gonorrhea in women.
"We are thrilled to initiate the EVOGUARD trial to further
evaluate EVO100 for prevention of chlamydia and gonorrhea infection
in women, for which there are currently no prescription products
available," said Kelly Culwell, MD, Chief Medical Officer for
Evofem Biosciences. "Evofem continues to establish itself as a
company that can develop and deliver unique products and product
candidates to address the true unmet needs of women."
Rates of infection for Chlamydia trachomatis and
Neisseria gonorrhea climbed in 2018 for the fifth
consecutive year in the United
States.1 Globally, an estimated 95 million
women are likely to contract chlamydia or gonorrhea by
2025.2
Gonorrhea is increasingly becoming antibiotic resistant, making
it much harder, or sometimes impossible, to
treat.3
"The dramatic rise and increasing prevalence of chlamydia and
gonorrhea, along with the emergence of multi-drug resistant
gonorrhea, make the development of a preventative measure such as
EVO100 even more critical," Dr. Culwell added.
EVOGUARD is a double-blind, placebo-controlled Phase 3
clinical trial designed to evaluate the safety and efficacy of
EVO100 for the prevention of urogenital Chlamydia
trachomatis and Neisseria gonorrhea infection in
women.
The study will enroll 1,730 women who have had a urogenital
chlamydia or gonorrhea infection at any time over the 16 weeks
preceding the Enrollment Visit along with one or more risk factors
for infection. Participating women will be randomized to
receive either EVO100 vaginal gel or placebo, and will remain in
the study until completion of 16 weeks of study medication or
observation or testing positive for chlamydia or gonorrhea
infection.
In September 2020, pivotal results
from Evofem's double-blinded, placebo-controlled
Phase 2b 'AMPREVENCE' trial were presented at
the 2020 STD Prevention Virtual Conference in a poster
titled "Efficacy and safety of a novel vaginal pH modulator for
prevention of chlamydia and gonorrhea."
AMPREVENCE enrolled 860 women who had been treated for chlamydia
or gonorrhea in the four months prior to enrolling in the study.
Fifty centers in the United States participated in
this unprecedented trial.
EVO100 has been granted Fast Track Designation for the
prevention of chlamydia in women by the FDA, and is an
FDA-designated Qualified Infectious Disease Product (QIDP) for the
prevention of gonorrhea in women.
EVOGUARD is funded in part by a recent strategic investment in
Evofem by Adjuvant Capital, LLC.
About Evofem Biosciences
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
evaluating EVO100 in a Phase 3 clinical
trial, 'EVOGUARD,' for the prevention of urogenital
Chlamydia trachomatis and Neisseria
gonorrhoeae infection 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 the ongoing EVOGUARD clinical
trial of EVO100 for prevention of Chlamydia
trachomatis and Neisseria
gonorrhoeae infection in women. 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 Chlamydia, gonorrhea, trichomonas and syphilis:
global prevalence and incidence estimates. June 6, 2019.
3 Centers for Disease Control and Prevention
(2018): Antibiotic-Resistant Gonorrhea Basic Information.
Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
Media Contact
Ellen
Thomas
Evofem Biosciences, Inc.
ethomas@evofem.com
Mobile: (718) 490-3248
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SOURCE Evofem Biosciences, Inc.