Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the initiation of a Phase 1 clinical
trial of DARE-HRT1.
DARE-HRT1 is designed to deliver bio-identical
17β-estradiol and bio-identical progesterone continuously over a
28-day period and is being developed as a potential new option for
hormone therapy (HT) for the treatment of vasomotor symptoms,
commonly called hot-flashes, and the genitourinary syndrome of
menopause to prevent bone loss and fracture associated with
menopause. The North American Menopause Society (NAMS)
hormone therapy position statement supports the use of HT in peri-
and post-menopausal women, recommends administering both estrogen
to reduce symptoms and progesterone to prevent thickening of the
uterine wall and observes that non-oral routes of administration
may offer advantages over orally administered therapies.1
DARE-HRT1 has the potential to be the first FDA-approved
intravaginal ring (IVR) product to meet these NAMS guidelines.
“We believe this study will provide important
scientific information for both DARE-HRT1 and DARE-FRT1, two of our
development-stage programs, given that they both utilize the same
IVR technology and bio-identical progesterone as an active
ingredient,” said David Friend, PhD, Chief Scientific Officer of
Daré Bioscience. “Specifically, this Phase 1 study of DARE-HRT1
will evaluate the ability of DARE-HRT1 to achieve its target dual
release objectives, as well as the ability of the IVR technology to
release two different active drugs at two different rates. In
addition, we anticipate collecting useful pharmacokinetics
characteristics of the bio-identical progesterone alone, which can
be expected to directly apply to DARE-FRT1, a bio-identical
progesterone-only IVR being developed for luteal phase support as
part of an invitro fertilization regimen and as a more convenient
treatment option for prevention of pre-term birth.”
The randomized Phase 1 study will evaluate the
pharmacokinetics (PK) of DARE-HRT1 in approximately 30 healthy,
post-menopausal women. The primary objective of the study is
to describe the PK parameters over 28 days of two different dose
combinations of DARE-HRT1. Secondary endpoints of the study
include assessing the safety and tolerability of DARE-HRT1 and
comparing the exposure of estradiol, estrone, and progesterone of
DARE-HRT1 over 28 days against a daily combination of oral estrogen
(Estrofem®) and oral progesterone (Prometrium®).
The Phase 1 study of DARE-HRT1 is being
conducted by Daré’s wholly-owned Australian subsidiary at specialty
women’s health sites in Australia. Currently, Australia’s research
and development tax incentive (R&DTI) gives 43.5% of every
dollar spent by eligible companies on eligible R&D activities
back to those companies in a cash payment. At the conclusion of the
Phase 1 study, Daré’s subsidiary intends to apply for the maximum
refundable cash credit then available under the Australian
R&DTI program for eligible study costs incurred.
“At Daré, we have a deep passion and commitment
for transforming science into solutions for women,” said Sabrina
Martucci Johnson, President and CEO of Daré Bioscience. “The
polymer-based segmented IVR delivery platform developed by renowned
scientists Dr. Robert Langer from the Massachusetts Institute of
Technology and Dr. William Crowley from Massachusetts General
Hospital and Harvard Medical School is a truly innovative
technology designed specifically for women to avoid first-pass
metabolic effects commonly seen with oral medications and to offer
potentially more convenient approaches for sustained delivery of
one or more active drugs at variable doses and convenient
durations, including a once-a-month option. The potential
cost savings afforded by the Australian R&D tax incentive
program provides an opportunity to advance potential
first-in-category product candidates like DARE-HRT1 and DARE-FRT1
capital efficiently.”
1. Menopause:
The Journal of The North American Menopause Society, Vol. 24, No.
7, pp. 728-53 (2017)
About Daré Bioscience
Daré Bioscience is a clinical-stage
biopharmaceutical company committed to the advancement of
innovative products for women’s health. The company’s mission is to
identify, develop and bring to market a diverse portfolio of
differentiated therapies that expand treatment options, improve
outcomes and facilitate convenience for women, primarily in the
areas of contraception, vaginal health, sexual health, and
fertility.
Daré’s clinical-stage product candidates include
potential first-in-category candidates in clinical development:
Ovaprene®, a hormone-free, monthly contraceptive intravaginal ring
whose U.S. commercial rights are under a license agreement with
Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of
sildenafil to treat female sexual arousal disorder utilizing the
active ingredient in Viagra®; DARE-BV1, a unique hydrogel
formulation of clindamycin phosphate 2% to treat bacterial
vaginosis via a single application; and DARE-HRT1, a combination
bio-identical estradiol and progesterone intravaginal ring for
hormone replacement therapy following menopause. To learn more
about Daré’s full portfolio of women’s health product candidates,
and mission to deliver differentiated therapies for women, please
visit www.darebioscience.com.
Daré may announce material information about its
finances, product candidates, clinical trials and other matters
using its investor relations website
(http://ir.darebioscience.com), SEC filings, press releases, public
conference calls and webcasts. Daré will use these channels to
distribute material information about the company, and may also use
social media to communicate important information about the
company, its finances, product candidates, clinical trials and
other matters. The information Daré posts on its investor relations
website or through social media channels may be deemed to be
material information. Daré encourages investors, the media, and
others interested in the company to review the information Daré
posts on its investor relations website
(https://darebioscience.gcs-web.com/) and to follow these Twitter
accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the
list of social media channels the company may use to communicate
information will be posted on the investor relations page of Daré’s
website mentioned above.
Forward-Looking Statements
Daré cautions you that all statements, other
than statements of historical facts, contained in this press
release, are forward-looking statements. Forward-looking
statements, in some cases, can be identified by terms such as
“believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“design,” “intend,” “expect,” “could,” “plan,” “potential,”
“predict,” “seek,” “should,” “would,” “contemplate,” “project,”
“target,” “tend to,” or the negative version of these words and
similar expressions. Such statements include, but are not limited
to, the potential for DARE-HRT1 to safely and effectively treat
menopausal symptoms, the potential for DARE-HRT1 to be the first
FDA-approved IVR to deliver bio-identical progesterone in
combination with bio-identical estradiol; the utility of the Phase
1 clinical study of DARE-HRT1 in the development of DARE-FRT1, and
the potential to receive a significant refundable tax credit under
Australia’s R&D tax incentive program for eligible costs
incurred in the conduct of the Phase 1 clinical study of DARE-HRT1.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause Daré’s actual
results, performance or achievements to be materially different
from future results, performance or achievements expressed or
implied by the forward-looking statements in this press release,
including, without limitation, risk and uncertainties related to:
Daré’s ability to raise additional capital when and as needed to
advance its product candidates and continue as a going concern; the
effects of the COVID-19 pandemic on Daré’s operations, financial
results and condition, and ability to achieve current plans and
objectives, including the potential impact of the pandemic on
Daré’s ability to timely enroll, conduct and report results of its
clinical trials and on the ability of third parties on which Daré
relies to assist in the conduct of its business, including its
clinical trials, to fulfill their contractual obligations to Daré;
Daré’s ability to develop, obtain regulatory approval for, and
commercialize its product candidates; the failure or delay in
starting, conducting and completing clinical trials or obtaining
U.S. Food and Drug Administration (FDA) or foreign regulatory
approval for Daré’s product candidates in a timely manner; Daré’s
ability to conduct and design successful clinical trials, to enroll
a sufficient number of patients, to meet established clinical
endpoints, to avoid undesirable side effects and other safety
concerns, and to demonstrate sufficient safety and efficacy of its
product candidates; the risk that positive findings in early
clinical and/or nonclinical studies of a product candidate may not
be predictive of success in subsequent clinical and/or nonclinical
studies of that candidate; Daré’s ability to retain its licensed
rights to develop and commercialize a product candidate; Daré’s
ability to satisfy the monetary obligations and other requirements
in connection with its exclusive, in-license agreements covering
the critical patents and related intellectual property related to
its product candidates; developments by Daré’s competitors that
make its product candidates less competitive or obsolete; Daré’s
dependence on third parties to conduct clinical trials and
manufacture clinical trial material; Daré’s ability to adequately
protect or enforce its, or its licensor’s, intellectual property
rights; the lack of patent protection for the active ingredients in
certain of Daré’s product candidates which could expose its
products to competition from other formulations using the same
active ingredients; the risk of failure associated with product
candidates in preclinical stages of development that may lead
investors to assign them little to no value and make these assets
difficult to fund; and disputes or other developments concerning
Daré’s intellectual property rights. Daré’s forward-looking
statements are based upon its current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. All forward-looking statements are expressly qualified
in their entirety by these cautionary statements. For a detailed
description of Daré’s risks and uncertainties, you are encouraged
to review its documents filed with the SEC including Daré’s recent
filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not
to place undue reliance on forward-looking statements, which speak
only as of the date on which they were made. Daré undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were made,
except as required by law.
Investors on behalf of Daré Bioscience, Inc.:Lee
RothBurns McClellanEmail: lroth@burnsmc.com +1 212-213-0006
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