-- Top-line readout of data expected in
October 2022 --
-- U.S. regulatory submission planned for
the first half of 2023 --
-- Phexxi may become the first-ever
woman-controlled prophylactic for the prevention of chlamydia and
gonorrhea --
SAN
DIEGO, Aug. 1, 2022 /PRNewswire/
-- Evofem Biosciences, Inc., (Nasdaq: EVFM) today
announced that the last subject has completed her last visit in
EVOGUARD, the Company's registrational Phase 3 trial
evaluating the efficacy and safety of Phexxi® (lactic acid, citric
acid, potassium bitartrate) for the prevention of chlamydia and
gonorrhea infection in women. There are no prescription
pharmaceuticals approved to prevent these sexually transmitted
infections (STIs).
Top-line data from EVOGUARD is expected in
October 2022. Evofem expects positive
outcomes would enable the Company to submit regulatory applications
in the first half of 2023 to the U.S. Food and Drug Administration
(FDA) to expand Phexxi's approved indications to include prevention
of urogenital chlamydia and gonorrhea in women. Phexxi is currently
approved in the U.S. for the prevention of pregnancy.
"This is a major milestone for Evofem and brings us closer to
our goal of providing women a safe and effective, woman-controlled
prophylactic measure against chlamydia and gonorrhea, the two most
commonly reported sexually transmitted infections in the U.S.,"
said Saundra Pelletier, Chief
Executive Officer of Evofem. "We believe these potential new
indications represent significant upside for shareholders, above
and beyond the multi-billion-dollar birth control market which we
continue to increasingly penetrate with Phexxi for hormone-free
contraception."
20% of people in the U.S. had an STI on any given day in
2018, according to a 2021 study in the journal Sexually
Transmitted Diseases. The CDC estimates that 4.0 million and
1.6 million new cases of chlamydia and gonorrhea, respectively,
occurred that year.1 Infected people are often
unaware of, and do not seek treatment for their infections. Almost
60% of women infected with chlamydia have no
symptoms.2
Chlamydia is the most frequently reported bacterial
infection in the U.S. and can infect both men and women. It can
cause serious, permanent damage to a woman's reproductive system
and make it difficult or impossible for a woman to become pregnant
later in life.
Chlamydia and gonorrhea have been reported to be responsible for
one-third to half of pelvic inflammatory disease (PID) cases.
PID can cause serious, long-term problems including
infertility, ectopic pregnancy, and chronic pelvic pain.
EVOGUARD builds on the positive, statistically
significant outcomes of AMPREVENCE, the randomized,
double-blind placebo-controlled Phase 2b/3 study evaluating Phexxi for the prevention
of chlamydia and gonorrhea. AMPREVENCE met its primary and
secondary endpoints and showed that the product was generally safe
and well-tolerated.
The FDA has granted Fast Track designation and "Qualified
Infectious Disease Product" (QIDP) designation to Evofem's product
candidate for the prevention of both chlamydia and gonorrhea
in women.
The Fast Track program facilitates the expedited
development and review of new drugs or biologics that are intended
to treat serious or life-threatening conditions and demonstrate the
potential to address unmet medical needs. The purpose is to get
important new drugs to the patient earlier.
QIDP designation is intended to encourage development of new
products for the treatment of serious or life-threatening
infections. A drug or product in development that receives this
designation qualifies for an additional five years of
marketing exclusivity following FDA approval for that
indication.
Evofem is grateful to the study investigators and coordinators
at the more than 100 participating study centers across the U.S.,
as well as the 1,903 women who participated in this landmark
study.
About Evofem Biosciences
Evofem Biosciences, Inc.,
(Nasdaq: EVFM) is 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 chlamydia and gonorrhea. The Company's first
FDA-approved product, Phexxi® (lactic acid, citric acid
and potassium bitartrate), is a hormone-free, on-demand
prescription contraceptive vaginal gel. It comes in a box of 12
pre-filled applicators and is applied 0-60 minutes before each act
of sex. The Company expects to report top-line data this fall from
its registrational Phase 3 EVOGUARD clinical trial
evaluating Phexxi for two potential new indications – prevention of
chlamydia and prevention of gonorrhea in women. Learn more
at phexxi.com and evofem.com.
Phexxi® is a registered trademark of Evofem
Biosciences, Inc.
About Phexxi
Phexxi is an on-demand method of birth
control used to prevent pregnancy. Phexxi is not effective when
used after sex.
Important Safety Information
- Rare cases (0.36%) of bladder and kidney infections have been
reported. If you have a history of urinary tract problems that keep
coming back, you should not use Phexxi.
- Contact your healthcare provider if you are experiencing
genitourinary side effects such as vaginal burning, itching,
discharge, genital discomfort (including in male partners), yeast
infection, urinary tract infection, or bacterial vaginosis.
- Phexxi does not protect against sexually transmitted
infections, including HIV.
For more information about Phexxi, talk to your healthcare
provider and see full Product Information
at www.phexxi.com. Please report side effects by
contacting Evofem Biosciences toll-free at 1-833-EVFMBIO or contact
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Intended for United States residents only.
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, the expansion of Phexxi's label, any FDA approvals of
new indications and the resulting effect on stockholder value,
evaluations and judgments regarding Evofem, its products, its
product candidates and their development, and demand for Evofem's
products and product candidates. 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 the
Company's SEC filings, including its Annual Report on Form 10-K for
the year ended December 31, 2021, filed with the SEC
on March 10, 2022 and its Quarterly Report on Form 10-Q filed
with the SEC on May 10, 2022. All
forward-looking statements are expressly qualified in their
entirety by such factors. The Company does not undertake any duty
to update any forward-looking statement except as required by
law.
Sources:
- https://www.cdc.gov/std/infertility/default.htm#infnote1
- Patel, Chirag G et al. "The Proportion of Young Women Tested
for Chlamydia Who Had Urogenital Symptoms in Physician Offices."
Sexually Transmitted Diseases vol. 45,9 (2018)
Investor Relations
Contact
Amy Raskopf
Evofem Biosciences,
Inc.
araskopf@evofem.com
(917)
673-5775
|
Media
Contact
media@evofem.com
|
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SOURCE Evofem Biosciences, Inc.