- Phase 2B/3 AMPREVENCE Clinical
Trial Concluded with Women Experiencing a 50 Percent Risk Reduction
in Chlamydia Trachomatis (chlamydia) and a 78 Percent Risk
Reduction in Neisseria Gonorrhoeae (gonorrhea) using EVO100
(investigational name for Phexxi® (lactic acid, citric
acid, and potassium bitartrate)) Compared to Placebo
- AMPREVENCE Also Incorporated Direct Patient Health Outcomes
Related to Sexual Satisfaction
- Positive AMPREVENCE Data Serve as the Foundation for the
Ongoing, Confirmatory and Registrational Phase 3 EVOGUARD Trial
Investigating EVO100 to Prevent Chlamydia and Gonorrhea in
Women
- Topline Data from Phase 3 EVOGUARD Trial Expected in the
Second Half of 2022
SAN
DIEGO, March 31, 2022 /PRNewswire/ -- Evofem
Biosciences, Inc., (Nasdaq: EVFM) today presented
data at the Academy of Managed Care Pharmacy (AMCP) annual
meeting showing EVO100 (the investigational name for
Phexxi®) provided a significant decrease in gonorrhea
and chlamydia infections in women as well as additional patient
health outcomes related to satisfaction with use of the
investigational product. The results are based on Evofem's Phase
2B/3 AMPREVENCE clinical trial.
Additional data from the AMPREVENCE trial were collected to
evaluate information regarding patient satisfaction and adherence
to the treatment.
"Findings from these analyses demonstrate the significant impact
EVO100 can potentially have in reducing the incidence of chlamydia
and gonorrhea as well as set the stage with health insurers and
pharmacy benefit managers for access to this investigational
product, if approved for the additional indications," said
Brandi Howard, PhD, Head of Medical
and Clinical Affairs at Evofem and leader of the AMPREVENCE trial.
"We continue to see notable increases in chlamydia and gonorrhea
diagnoses in the United States,
suggesting that additional options to prevent these infections are
needed. We look forward to the topline data readout from the
EVOGUARD trial later this year."
AMPREVENCE was a randomized, controlled Phase 2B/3 trial, with 860 sexually active women
between the ages of 18-45 who had documented chlamydia or gonorrhea
infections within 16 weeks of enrollment.
In the AMPREVENCE study, EVO100 reduced the overall risk of
chlamydia by 50% and the risk of gonorrhea by 78%. The chlamydia
infection rate in EVO100 users was 4.8% (14/289) compared to 9.7%
(28/290) among placebo users (P=0.0256), representing a relative
risk reduction of 50%. For gonorrhea, the infection rate was 0.7%
(2/280) in the EVO100 arm compared to 3.2% (9/277) in the placebo
arm (P=0.0316), a relative risk reduction of 78%.
Adverse events, which were genitourinary in nature, were in line
with previous trials investigating Phexxi.
"We learned a lot from this Phase 2B/3 trial and were eager to apply those
learnings to the confirmatory and registrational Phase 3 EVOGUARD
study," said Dr. Todd Chappell, a
practicing obstetrician and gynecologist, the lead investigator for
the AMPREVENCE trial and an investigator in the EVOGUARD trial. "We
increased the size of the Phase 3 EVOGUARD trial, making it the
largest ever to evaluate efficacy and safety in the prevention of
chlamydia and gonorrhea, and we hope to provide further and more
definitive evidence that, if approved, EVO100 can offer women the
chance to protect themselves from these sexually transmitted
infections and potentially provide improved satisfaction with
use."
In March of 2021, the American Journal of Obstetrics and
Gynecology published the full data set from the AMPREVENCE
trial.
Topline data from the Phase 3 confirmatory and registrational
EVOGUARD trial are expected in the second half of 2022.
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
provide 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.
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. 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, 2021, filed with the SEC
on March 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.
Media Contact
Jack Hirschfield
Evofem Biosciences, Inc.
jhirschfield@evofem.com
(512) 674-5163
Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
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SOURCE Evofem Biosciences, Inc.