Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced that Climacteric, the official journal
of the International Menopause Society, published safety and
acceptability results from a Phase 1 clinical trial of DARE-HRT1,
an investigational ethylene vinyl acetate copolymer intravaginal
ring (IVR) designed to release bio-identical 17β-estradiol (E2) and
progesterone (P4) over 28 days. DARE-HRT1 is being developed for
the treatment of moderate-to-severe vasomotor symptoms (VMS) due to
menopause in women with intact uteri.
Hormone therapy is used to treat 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. The North American
Menopause Society’s (NAMS) guidance on hormone therapy states that
dosing estrogen and progestogen in combination may offer important
benefits to women, and NAMS observed that non-oral routes of
administration may offer advantages over orally administered
therapies.
“We are very encouraged by these data which indicate that our
candidate, DARE-HRT1, was well-tolerated and highly acceptable for
the majority of women in both IVR treatment groups,” said David
Friend, PhD, Chief Scientific Officer for Daré Bioscience. “Sharing
these data from our Phase 1 trial, in a recognized peer-reviewed
journal, allows us to highlight the scientific rigor of our
development process and showcase our innovative IVR drug delivery
technology platform.”
Approximately 30 healthy, postmenopausal women participated in
the open-label, three-arm Phase 1 study. Women in first arm
received one DARE-HTR1 ring for 28 days designed to release E2 at a
rate of 80 μg/day and P4 at 4 mg/day, and women in the second arm
received an alternative DARE-HRT1 ring for 28 days designed to
release 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. The primary objective of the study was to assess the
pharmacokinetics from the two dosage strengths of the DARE-HRT1
IVRs. The secondary objective of the study was to assess the safety
of the IVRs while the exploratory objectives were to assess
usability and participant tolerability of the IVRs.
The study demonstrated that the DARE-HRT1 IVRs, in general, were
safe and well tolerated in healthy postmenopausal women and
treatment emergent adverse events profiles were comparable between
the DARE-HRT1 groups and the reference oral regimen group.
“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,” said Sabrina Martucci Johnson, President and CEO
of Daré Bioscience. “This innovative drug delivery technology is
designed to release one or more active ingredients without the need
for a membrane or reservoir to contain the active drug(s) or to
control the release, allowing for sustained drug delivery. We
believe this IVR drug delivery technology platform has the
potential to result in products that offer women a number of
benefits as compared to currently marketed products, including the
opportunity to improve medication compliance, avoid first-pass
metabolic side effects and deliver a better overall user
experience.”
Previously reported topline efficacy data from a Phase 1 / 2
study of DARE-HRT1 demonstrated improvement in both VMS as well as
vaginal symptoms of menopause. 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.
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 Over 45 million women in the U.S. are estimated to be
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.2
- Menopause 101: A primer for the perimenopausal. NAMS, accessed
4 April 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, vaginal health,
reproductive health, menopause, sexual health and fertility.
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 menopausal hormone therapy. 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, the
potential for FDA approval of DARE-HRT1 based on a single Phase 3
clinical trial, and the potential benefits of treatment with a
Daré’s IVR product, if approved, compared with currently marketed
products for the same indication. 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,
execute its business strategy and continue as a going concern;
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; 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;
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.com646.930.4406
OR
Media on behalf of Daré Bioscience, Inc.:Jake RobisonEvoke
Canalejake.robison@evokegroup.com619.849.5383
Source: Daré Bioscience, Inc.
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