Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced the publication of data from a Phase 1
trial evaluating the pharmacokinetics of DARE-HRT1, an
investigational intravaginal ring (IVR) designed to deliver
bio-identical 17β-estradiol and bio-identical progesterone
continuously over a 28-day period as part of a hormone therapy
regimen, in the journal Menopause, which is the journal of the
North American Menopause Society. Daré previously reported positive
topline results from this study, as well as from a subsequent Phase
1 / 2 clinical trial of DARE-HRT1. The journal article entitled
“Evaluation of 28-Day Estradiol and Progesterone Vaginal Rings in a
Phase 1 Clinical Pharmacokinetic Study” is available at the
Menopause journal’s website in the Latest Articles section.
Hormone therapy is used to treat the vasomotor
symptoms (VMS) and genitourinary syndrome associated with
menopause. DARE-HRT1 has the potential to be the first FDA-approved
product to offer vaginal delivery of combination bio-identical
estradiol and bio-identical progesterone hormone therapy in a
convenient monthly format. Daré plans to advance DARE-HRT1 into a
single Phase 3 clinical trial to support a new drug application for
DARE-HRT1 for the treatment of moderate to severe VMS due to
menopause in women with intact uteri.
“We are excited to have this peer-reviewed
article published in the North American Menopause Society’s journal
as we believe that the delivery of hormone therapy over 28-days
utilizing a novel intravaginal ring which requires no daily action
on the part of the patient, or the provider, supports DARE-HRT1’s
potential to be a first-in-category, convenient non-oral and
non-daily option for women suffering from menopausal symptoms,”
said Sabrina Martucci Johnson, President and CEO of Daré
Bioscience.
“The North American Menopause Society believes
that hormone therapy is the most effective treatment for VMS and
the genitourinary symptoms of menopause and has stated that a
non-oral route of administration may offer potential advantages
over oral routes of administration. If successful, DARE-HRT1 could
be the first product approved to continuously deliver non-oral
hormone therapy with both estradiol and progesterone together over
multiple weeks,” said David Friend PhD, Chief Scientific Officer
for Daré Bioscience. “In this open-label, three-arm study, the
DARE-HRT1 IVRs were able to demonstrate steady-state plasma
concentrations of estradiol similar to those seen with drug
products approved by the FDA for treatment of VMS and genitourinary
symptoms of menopause.”
The IVR technology used in DARE-HRT1 was
developed by Dr. Robert Langer from
the Massachusetts Institute of Technology and Dr.
William Crowley from Massachusetts General
Hospital and Harvard Medical School. Unlike other IVR
technologies, Daré’s IVR drug delivery technology is designed to
release more than one active ingredient via a solid ethylene vinyl
acetate polymer matrix without the need for a membrane or reservoir
to contain the active drug or to control the release, allowing for
sustained drug delivery.
Thirty-two (32) healthy postmenopausal women,
with an average age of 57 years, were recruited at two Australian
sites to participate in this open-label, three arm study. The first
arm received one DARE-HTR1 ring for 28 days designed to release
17β-estradiol (E2) at a rate of 80 μg/day and progesterone (P4) at
4mg/day. The second arm received an alternative DARE-HRT1 ring for
28 days releasing E2 at 160 μg/day and P4 at 8mg/day. The third arm
received both oral Estrofem (1mg E2) and Prometrium (100 mg P4)
daily for 29 days. Blood samples were taken predose then
intensively over the first day (day 1) and periodically thereafter
over the remaining 27 days. After removal of the DARE-HRT1 rings on
the morning of day 29, intensive samples were collected. Similar
procedures were conducted with women enrolled in the oral group.
The plasma samples were analyzed for E2, estrone (E1), and P4 using
validated bioanalytical methods.
DARE-HRT1 505(b)(2) Regulatory
Pathway
Following clinical development, Daré intends to
leverage the existing safety and efficacy data on the active
ingredients in DARE-HRT1, estradiol and progesterone, to utilize
the U.S. Food and Drug Administration’s (FDA) 505(b)(2) pathway to
obtain marketing approval of DARE-HRT1 in the U.S.
Daré intends to seek FDA approval of DARE-HRT1
for the treatment of moderate to severe VMS due to menopause in
women with intact uteri. Based on pre-IND communications with the
FDA and the topline PK data from the DARE-HRT1 Phase 1 / 2 study,
Daré believes FDA approval of DARE-HRT1 for that indication is
achievable via the 505(b)(2) pathway supported by a single,
placebo-controlled, Phase 3 clinical trial of DARE-HRT1 and a
scientifically justified PK “bridge” (via a relative
bioavailability trial) between DARE-HRT1 and the selected listed
estradiol and progesterone drugs. Ongoing activities to support
progressing directly into a single Phase 3 study to support
registration include manufacturing and non-clinical studies to
support the IND submission and the planned IND-opening Phase 3
study.
About Menopause
Menopause is defined as the final menstrual
period and is typically confirmed after a woman has missed her
period for 12 consecutive months. Most women experience menopause
between ages 40 and 58.1 An estimated 45 million women in
the U.S. are approaching or in menopause, which results
in a decrease in estrogen and other hormones.1,2 Hot flashes,
vaginal dryness and loss of bone density are frequently associated
with menopause. Night sweats (hot flashes that occur during sleep)
often cause sleep disturbance, and vaginal atrophy (the drying
and thinning of vaginal tissues) can cause a feeling of vaginal
tightness during sex along with pain, burning, or
soreness.1 Hence, management of menopausal symptoms can impact
quality of life, productivity and health. The North American
Menopause Society (NAMS) believes that hormone therapy is the
most effective treatment for VMS and the genitourinary syndrome of
menopause and observes that a non-oral route may offer potential
advantages over oral routes of administration because non-oral
routes bypass the first-pass hepatic effect.2
- Menopause 101: A primer for the perimenopausal. NAMS,
accessed 6 January
2023. http://www.menopause.org/for-women/menopauseflashes/menopause-symptoms-and-treatments/menopause-101-a-primer-for-the-perimenopausal.
- NAMS Position Statement. The 2022 hormone therapy position
statement of The North American Menopause Society. Menopause: The
Journal of The North American Menopause Society Vol. 29, No. 7, pp.
767-794 DOI: 10.1097/GME.0000000000002028.
https://www.menopause.org/docs/default-source/professional/nams-2022-hormone-therapy-position-statement.pdf
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company
committed to advancing 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 prioritize
women's health and well-being, expand treatment options, and
improve outcomes, primarily in the areas of contraception,
fertility, and vaginal and sexual health.
Daré’s first FDA-approved product, XACIATO™
(clindamycin phosphate) vaginal gel, 2% is a lincosamide
antibacterial indicated for the treatment of bacterial vaginosis in
female patients 12 years of age and older, which is under a global
license agreement with Organon. XACIATO is a clear, colorless,
viscous gel, to be administered once intravaginally as a single
dose. Daré’s portfolio also includes potential first-in-category
candidates in clinical development: Ovaprene®, a novel,
hormone-free monthly intravaginal contraceptive 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®; and DARE-HRT1, a combination bio-identical
estradiol and progesterone intravaginal ring for hormone therapy
following menopause. To learn more about XACIATO, Daré’s full
portfolio of women’s health product candidates, and Daré’s mission
to deliver differentiated therapies for women, please visit
www.darebioscience.com.
Daré may announce material information about its
finances, product and product candidates, clinical trials and other
matters using the Investors section of its 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 and 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 in the Investors section of its website 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 in
the Investors section of Daré’s website.
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,” “objective,” or the negative version of these words and
similar expressions. In this press release, forward-looking
statements include, but are not limited to, statements relating to
DARE-HRT1’s potential as a safe and effective hormone therapy for
symptoms of menopause, DARE-HRT1’s potential to be the first
FDA-approved monthly IVR product delivering both estrogen and
progestogen hormone therapy for symptoms of menopause, the
importance of the results of the Phase 1 and Phase 1 / 2 clinical
studies to Daré and DARE-HRT1, the anticipated regulatory approval
pathway for DARE-HRT1, and the potential for FDA approval of
DARE-HRT1 for the treatment of moderate to severe VMS due to
menopause in women with intact uteri based on a single Phase 3
clinical trial together with study data that establishes a
scientific bridge to the selected listed drugs. 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 those expressed or
implied by the forward-looking statements in this press release,
including, without limitation: 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 develop,
obtain FDA or foreign regulatory approval for, and commercialize
its product candidates and to do so on communicated timelines;
failure or delay in starting, conducting and completing clinical
trials of a product candidate; Daré’s ability to design and conduct
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; Daré’s dependence on third parties to conduct clinical
trials and manufacture and supply clinical trial material and
commercial product; the risk that development of a product
candidate requires more clinical or nonclinical studies than Daré
anticipates, or that the duration of a study or number of study
subjects must be significantly greater than anticipated; Daré’s
ability to raise additional capital when and as needed to advance
its product candidates, execute its business strategy and continue
as a going concern; the loss of, or inability to attract, key
personnel; the effects of the COVID-19 pandemic, macroeconomic
conditions such as inflation, rising interest rates and
geopolitical events 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 commence, 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 to fulfill their contractual
obligations to Daré; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; the risk that developments by competitors make
Daré’s product or product candidates less competitive or obsolete;
difficulties establishing and sustaining relationships with
development and/or commercial collaborators; failure of Daré’s
product or product candidates, if approved, to gain market
acceptance or obtain adequate coverage or reimbursement from
third-party payers; Daré’s ability to retain its licensed rights to
develop and commercialize a product or 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 and product candidates; 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; product liability claims; governmental
investigations or actions relating to Daré’s product or product
candidates or the business activities of Daré, its commercial
collaborators or other third parties on which Daré relies; the
impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; cyber attacks, security
breaches or similar events that compromise Daré’s technology
systems or those of third parties on which it relies and/or
significantly disrupt Daré’s business; 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.
Contacts:
Investors on behalf of Daré Bioscience,
Inc.:Lee RothBurns
McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience,
Inc.:Jake RobisonEvoke
Canalejake.robison@evokegroup.com619.849.5383
Source: Daré Bioscience, Inc.
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