SAN DIEGO, Dec. 16, 2021 /PRNewswire/ -- Evofem Biosciences,
Inc. (NASDAQ: EVFM) and Orion Biotechnology Canada Ltd. today
announced that they have entered into a collaboration agreement to
evaluate the compatibility and stability of Orion's novel CCR5
antagonist, OB-002, in Evofem's Phexxi® (lactic acid, citric acid
and potassium bitartrate) vaginal gel with the goal of developing a
Multipurpose Prevention Technology (MPT) product candidate for
indications including the prevention of HIV in women.
The World Health Organization reported in 2020 that
approximately 37.6 million people globally were living with HIV and
an estimated 1.5 million individuals were newly diagnosed as
HIV-positive. There are limited methods available to prevent
transmission of HIV, and no products are approved to simultaneously
prevent pregnancy, STIs and HIV.
This collaboration will focus on determining compatibility and
stability of OB-002 in Phexxi and is expected to yield results in
the third quarter of 2022. Assuming positive results, the companies
will seek government and philanthropic funding for subsequent
clinical trials of the MPT vaginal gel product candidate.
"For too long, women have had to assemble a grab-bag of products
to protect against pregnancy, various STIs, and HIV," said
Saundra Pelletier, Chief Executive
Officer of Evofem Biosciences. "This partnership with Orion aims to
develop a first-of-its-kind product with potential to revolutionize
the way women protect their sexual and reproductive health: no
unintended pregnancies, no STIs, and no HIV -- all in one
applicator."
Ian McGowan, Chief Medical
Officer of Orion Biotechnology, added, "It is unacceptable that we
are still seeing high rates of new HIV infections among women each
year and there is clearly a compelling need to expand the HIV
prevention portfolio. Orion is very excited to be collaborating
with Evofem to address this important issue and develop an MPT
product for women across the world."
In trials to date of Orion's novel CCR5 antagonist, OB-002 has
demonstrated best-in-class in vitro potency. OB-002 was
100% effective in blocking transmission of HIV infection in a
non-human primate model.1 A 15-subject Phase 1 study of
vaginally administered OB-002 gel demonstrated that the OB-002 gel
was safe and well tolerated, with no evidence of systemic
absorption.2
Phexxi is a hormone-free, on-demand prescription
contraceptive vaginal gel that was launched in the U.S. in
September 2020. Top-line data is
expected from Evofem's pivotal Phase 3 trial for the prevention of
chlamydia and gonorrhea in women in the second half of 2022.
1 Veazey et al. Topical OB-002 is
highly effective in preventing vaginal transmission of SHIV1623P in
a non-human primate (NHP) model of HIV infection. JID,
2009.
2 McGowan et al. Evaluation of the Safety,
Acceptability, and Pharmacokinetic Profile of a Gel Formulation of
OB-002 in Healthy Volunteers. AIDS Res Hum Retroviruses,
2021.
About Evofem Biosciences
Evofem Biosciences, Inc.,
(NASDAQ: EVFM) is developing and commercializing innovative
products and product candidates 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.
About Orion Biotechnology
Orion Biotechnology Canada
Ltd. is a clinical stage company unlocking the therapeutic
potential of G Protein-Coupled Receptors (GPCRs) with a novel drug
modality, proven discovery platform and best-in-class molecules.
The company is advancing a diversified pipeline of potential
first-in-class/best-in-class antagonist and agonist therapies
against high-value GPCR targets in oncology, immunology and other
serious diseases. Orion is led by a highly experienced team with
world leading expertise in GPCR pharmacology and peptide/protein
engineering. Visit https://orionbiotechnology.com to
learn more.
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 anticipated cost, funding, timing
and potential outcome of the collaboration or the development of
any product candidate for the prevention of HIV in women. 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.
Contacts
For Evofem Biosciences, Inc.
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: 917.673.5775
For Orion Biotechnology Canada Ltd.
Ross MacLeod
info@orionbiotechnology.com
Phone: +1 343.291.1032
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SOURCE Evofem Biosciences, Inc.