SAN DIEGO, March 4, 2022 /PRNewswire/ -- Evofem Biosciences,
Inc., (Nasdaq: EVFM) announced today that it has completed
enrollment in EVOGUARD, the registrational Phase 3 clinical
trial evaluating EVO100 (the investigational name for
Phexxi® (lactic acid, citric acid, potassium
bitartrate)) for two potential new indications: the prevention of
chlamydia infection in women and the prevention of urogenital
gonorrhea infection in women.
The clinical trial design initially called for an enrollment of
1730 participants. Due to the high level of demand to enter the
study, investigators enrolled 1903 participants, providing the
potential for a more comprehensive understanding of the trial data
and outcomes.
Top-line data from EVOGUARD are expected in the
second half of 2022.
"I am seeing a significant increase in the number of chlamydia
and gonorrhea infections in my patients," said Dr. Todd Chappell, an investigator for the EVOGUARD
trial and practicing obstetrician and gynecologist. "There's a
notable need for new, effective and safe ways to prevent these
infections, and Phexxi, a potential preventive option against these
contagious diseases may offer women a form of protection against
these infections."
The CDC estimates that 4.0 million and 1.6 million new cases of
chlamydia and gonorrhea, respectively, occurred in 2018
alone.1 The number of reported cases is lower than
the estimated total number because 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.3
Completion of enrollment comes less than a month after the U.S.
Food and Drug Administration (FDA) awarded "Qualified Infectious
Disease Product" (QIDP) Designation to EVO100 (the investigational
name for Phexxi) for the prevention of urogenital chlamydia
infection in women. 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.
"Completing enrollment in EVOGUARD marks a major
milestone for Evofem and highlights our continuing efforts to
evaluate this potential first and only-in-class product in women
for the prevention of chlamydia and gonorrhea infections,"
said Saundra Pelletier, CEO of Evofem Biosciences. "As
we speak with women and observe the market environment, we
recognize the need to educate the public about these two sexually
transmitted infections and are working to seize the opportunity and
expand our role in helping women control and protect their sexual
health. If approved, Evofem can make an impact beyond preventing
unplanned pregnancy, and realize a sizeable new market
opportunity."
The FDA previously granted EVO100 Fast Track Designation for the
prevention of both chlamydia and gonorrhea, and in 2017 awarded
QIDP Designation to EVO100 for the prevention of gonorrhea in
women.
Evofem remains grateful to all those taking part in and
conducting the EVOGUARD trial, and all other ongoing
Evofem-sponsored research.
Sources:
1 https://www.cdc.gov/std/infertility/default.htm#infnote1
2 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): e72-e74. doi:10.1097/OLQ.0000000000000858
3 https://www.acog.org/en/womens-health/faqs/pelvic-inflammatory-disease
About Phexxi
Phexxi is an on-demand method of
birth control used to prevent pregnancy. Phexxi is not effective
when used after sex. For more information about Phexxi, talk
to your healthcare provide and see full Product Information
at www.phexxi.com.
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.
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.
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 certain sexually
transmitted infections (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. Learn more at phexxi.com and 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 timing and
outcome of the confirmatory Phase 3 trial, any submission or
approval of Phexxi to or by the FDA for the prevention of chlamydia
and gonorrhea, and the size of the market opportunity in preventing
chlamydia and gonorrhea. Various factors could cause actual results
to differ materially from those discussed or implied in the
forward-looking statements, including market and other conditions,
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, 2020, filed with the SEC
on March 4, 2021. 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.
Media
Contact
Jack
Hirschfield
Evofem Biosciences,
Inc.
jhirschfield@evofem.com
512-674-5163
Investor Relations
Contact
Amy
Raskopf
Evofem Biosciences,
Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
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SOURCE Evofem Biosciences, Inc.