SAN DIEGO, March 16, 2021 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) today announced publication of
the pivotal manuscript from the AMPREVENCE clinical trial in the
highly respected American Journal of Obstetrics and
Gynecology (AJOG). This double-blinded, placebo-controlled,
multicenter study of EVO100 met its primary and secondary efficacy
endpoints with statistically significant reductions in the
risk of chlamydia and gonorrhea infections in women at high risk of
infection.
"We believe publication of this important manuscript in such a
prestigious peer-reviewed journal further validates these
impressive AMPREVENCE trial outcomes and brings us one step closer
to being able to provide a woman-controlled, discreet option for
prevention of chlamydia and gonorrhea," said Brandi Howard, Ph.D., Evofem Biosciences' Head
of Medical Affairs. "Women deserve to have this significant unmet
need addressed. Evofem's dedication to bringing EVO100 to market as
quickly and safely as possible underscores our commitment to
serving women."
Chlamydia and gonorrhea are the most commonly reported sexually
transmitted infections in the U.S. Reported incidence in 2018
increased for the fifth consecutive year, despite the availability
of condoms for STI prevention.1,2 Currently, there
are no FDA-approved prescription products to prevent infection with
either of these pathogens. 78 million women are potentially at risk
of contracting sexually transmitted infections
(STIs).3
"My patients are encouraged by the possibility of finally having
an option to prevent STIs without having to rely on their partner
or sacrifice sexual pleasure. The positive results from the
AMPREVENCE trial help to advance reproductive health and serve as
the foundation for the current EVOGUARD trial," said B.
Todd Chappell, M.D., FACOG, lead
author and an obstetrician/gynecologist practicing
at Adams Patterson Gynecology &
Obstetrics in Memphis, Tennessee.
Building on the AMPREVENCE results, Evofem is currently
enrolling EVOGUARD, its pivotal Phase 3 clinical trial of EVO100
for prevention of chlamydia and gonorrhea in women. The trial is on
track to complete enrollment of the 1,730-subject cohort in 2021.
Evofem expects to report top-line data in mid-2022. Positive
EVOGUARD outcomes would support submission of a New Drug
Application to the U.S. Food and Drug Administration for these
potential indications by the end of 2022.
The in-press accepted manuscript, entitled EVO100
Prevents Chlamydia and Gonorrhea in Women at High-Risk for
Infection, is available online at
https://www.sciencedirect.com/science/article/abs/pii/S0002937821001563.
The final manuscript is expected to publish in an upcoming
edition of AJOG.
AMPREVENCE was conducted over approximately 16 weeks in women
age 18 to 45 years who were at risk of urogenital chlamydia and
gonorrhea infection. Enrolled women had been diagnosed and treated
for chlamydia or gonorrhea ≤16 weeks prior to enrollment. The 860
enrolled women were randomized 1:1 to receive EVO100 (n=426) or
placebo vaginal gel (n=434), and were instructed to apply the study
drug immediately prior or up to one hour prior to each act of
vaginal sexual intercourse. The primary and secondary endpoints
were the prevention of urogenital chlamydia and gonorrhea,
respectively.
In total, 764 women (EVO100: n=376; placebo: n=388) documented
using the study drug at least once. 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%. Increased efficacy was observed
with increased adherence, and chlamydia infection rates were
significantly reduced with increased adherence in the EVO100 group
compared to placebo.
Across both arms, there were similar rates of all-cause adverse
events (EVO100: 21.3%; placebo: 20.4%) and treatment-related
adverse events (EVO100: 7.2%; placebo: 7.5%). The most common
adverse events in the EVO100 arm were vulvovaginal candidiasis
(5.1%), vaginal discharge (3.2%), and urinary tract infection
(3.2%); and in the placebo arm, bacterial vaginosis (4.6%), urinary
tract infection (2.6%), and vaginal discharge (2.6%). Few women
discontinued due to adverse events in either arm (EVO100: 1.1%;
placebo: 1.5%). No treatment-related serious adverse events were
reported.
Exploratory outcomes included women's overall satisfaction with
EVO100. A majority (88%) of EVO100 users were satisfied or very
satisfied with EVO100 after 16 weeks of use.
About Evofem Biosciences
Evofem Biosciences, Inc.,
(NASDAQ: EVFM) is a commercial-stage biopharmaceutical company
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
launched its first commercial product, Phexxi® (lactic acid, citric
acid and potassium bitartrate), in the United States in
September 2020. 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 regarding the significance and implications
of publication in AJOG, the progress and prospects of the continued
development of EVO100, included any potential timelines or
evaluations of enrollment progress, the potential need or demand
for EVO100, statements and evaluations regarding or implying
potential market acceptance and patient attitudes. 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, 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.
This press release contains estimates and other statistical data
made by independent parties and by the Company relating to market
size and growth and other data about its industry. This data
involves a number of assumptions and limitations, and you are
cautioned not to give undue weight to such estimates.
References
- US. 2018. Centers for Disease Control and Prevention (2019):
CDC detailed fact sheet on gonorrhea. Available at
https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea-detailed.htm
- US. 2018. Centers for Disease Control and Prevention (2019):
CDC detailed fact sheet on chlamydia. Available at
https://www.cdc.gov/std/chlamydia/stdfact-chlamydia-detailed.htm
- Based on US Census Projections, CDC Data Brief 327, available
at https://www.cdc.gov/nchs/data/databriefs/db327_tables-508.pdf,
and primary market research data collected Q2 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.