SAN DIEGO, Dec. 17, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) today announced that its pivotal
Phase 3 trial, 'EVOGUARD,' of EVO100 for the prevention of
chlamydia and gonorrhea remains firmly on schedule. EVOGUARD was
initiated and the first patient was enrolled in October 2020, and study enrollment targets were
met in both October and November 2020
despite the ongoing COVID-19 pandemic.
"Inbound interest has been exceptionally high from women and
study centers alike, with more than double the number of planned
sites requesting to participate in this important clinical
trial," said Kelly Culwell, MD,
Chief Medical Officer of Evofem Biosciences. "Approximately
one-third of participating study centers will be up and running by
year-end 2020. We will activate all remaining sites in 2021, and
expect to complete enrollment of this 1,730-patient trial by
year-end 2021."
Despite the CDC recommendation for condom use to prevent
sexually transmitted infections (STIs), rates of infection
with Chlamydia trachomatis and Neisseria
gonorrhea climbed in 2018 for the fifth consecutive year
in the United
States.1 A large number of cases are
not reported because most people with chlamydia are asymptomatic
and do not seek testing.
"Any sexually active person can be infected with chlamydia or
gonorrhea, and despite current preventive measures, such as
condoms, the number of reported cases of these STIs continues to
rise," said Valerie Sorkin-Wells,
M.D., FACOG, of the Arizona Wellness Center for Women and a
Principal Investigator in the EVOGUARD clinical trial. "If the
results of the ongoing EVOGUARD trial confirm the statistically
significant AMPREVENCE trial results, EVO100 could be an important
new method to prevent the transmission of chlamydia and gonorrhea
in women."
EVO100 is an investigational vaginal gel designed to modulate
vaginal pH in the normal acidic range. It was previously evaluated
in a double-blinded, placebo-controlled Phase 2b trial, AMPREVENCE, conducted in 860 women at
50 U.S. study centers. This landmark study met its primary and
secondary efficacy endpoints,
with statistically significant reductions in chlamydia
and gonorrhea infection rates in women receiving EVO100 versus
placebo. There was a 50% reduction of risk in chlamydia
infection and 78% reduction of risk in gonorrhea infection
following 16 weeks of EVO100 use compared with placebo, and EVO100
was generally well tolerated with most side effects being mild to
moderate. These positive and statistically significant
outcomes were presented at the Virtual 2020 STD Prevention Conference in September 2020.
Chlamydia is the most frequently reported bacterial sexually
transmitted infection in the United
States2. It can cause cervicitis in women and
urethritis and proctitis in both men and women, and chlamydial
infections in women can lead to serious consequences including
pelvic inflammatory disease (PID), tubal factor infertility,
ectopic pregnancy, and chronic pelvic pain.
Gonorrhea, the second most frequently reported infectious
disease in the United States, is
increasingly becoming antibiotic resistant, making it much harder,
or sometimes impossible, to treat.3
The California Department of Public Health has received
increasing reports of disseminated gonococcal infections (DGI), an
uncommon but severe complication of untreated
gonorrhea4. DGI occurs when Neisseria gonorrhoeae
invades the bloodstream and spreads to distant sites in the body,
leading to clinical manifestations such as septic arthritis,
polyarthralgia, tenosynovitis, petechial/pustular skin lesions,
bacteremia, or, on rare occasions, endocarditis or meningitis.
EVO100 has been granted Fast Track Designation for the
prevention of chlamydia in women by the FDA. The vaginal pH
modulator is also an FDA-designated Qualified Infectious
Disease Product (QIDP) for the prevention of gonorrhea in
women. Under QIDP guidelines, EVO100 is eligible for certain
incentives, including priority review associated with a New Drug
Application (NDA) submission and a five-year extension of market
exclusivity upon FDA approval for this indication.
About EVOGUARD
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
at 90 study centers in the United States 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. For more
information, please visit www.evoguardstudy.com/ct/.
EVOGUARD is funded in part by a 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 registered 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.
4 California Department of Public Health Dear
Colleague Letter - Increasing Reports of Disseminated Gonococcal
Infection in CA. November 5,
2020.
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.