Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced positive topline efficacy results from
its Phase 1 / 2 clinical trial of DARE-HRT1. DARE-HRT1 is a novel,
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 (HT)
regimen. HT 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. The
topline data from the study demonstrated improvement in both VMS as
well as vaginal symptoms of menopause. 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.
“DARE-HRT1 demonstrated statistically significant improvement in
the VMS, also known as hot flashes, and the vaginal symptoms of
menopause, including dryness, in addition to improving vaginal pH
and the vaginal maturation index. These data support the potential
of DARE-HRT1 to deliver effective hormone therapy in a 28-day
intravaginal ring,” said Dr. Annie Thurman, Medical Director of
Daré Bioscience. “The delivery of hormone therapy over 28
consecutive days with no daily intervention supports DARE-HRT1’s
potential to be a first-in-category option, offering ease-of-use
and consistent dosing to women suffering from menopausal symptoms.
There are currently no FDA-approved products that continuously
deliver hormone therapy with both estradiol and progesterone
together over multiple consecutive weeks.”
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.
Data from a prior randomized, open-label, three-arm, parallel
group Phase 1 study that evaluated the pharmacokinetics (PK) of
DARE-HRT1 in approximately 30 healthy, post-menopausal women with
intact uteri demonstrated that DARE-HRT1 successfully delivered
both estradiol and progesterone over the 28-day evaluation
period. The estradiol PK data in that prior DARE-HRT1 Phase 1
study support the potential of DARE-HRT1 as an effective hormone
therapy for both VMS and vaginal symptoms associated with
menopause.
DARE-HRT1 Phase 1 / 2 Clinical Trial Study
Design
The randomized, open-label, two-arm, parallel group Phase 1/2
study was designed to evaluate DARE-HRT1’s safety, PK, and
preliminary efficacy in improving the VMS as well as the vaginal
symptoms of menopause in approximately 20 healthy, post-menopausal
women (age range 51-65 years, mean 59 years) with intact uteri over
approximately three consecutive months of use. The primary
objective of the study was to describe the safety, tolerability,
and PK of two different dose combinations over 12 weeks of use.
Secondary objectives of the study were to assess the usability,
participant tolerability, and preliminary effectiveness of
DARE-HRT1 for both the VMS and vaginal symptoms of menopause.
The study was conducted by Daré’s wholly owned subsidiary
in Australia.
Topline Results of the Phase 1 / 2 Clinical
Trial
The levels of estradiol released from both the lower and higher
dose formulation of DARE-HRT1 evaluated in the study achieved
statistically significant improvement in VMS as well as the
genitourinary symptoms of menopause, and vaginal pH and maturation
index.
Menopausal symptoms, including hot flashes and night sweats,
were reduced compared with baseline in both DARE-HRT1 dose groups
(p<0.01). Participants also showed significant improvement from
baseline in all measures surveyed on The Menopausal Quality of Life
Survey (MENQOL), which surveys not only parameters of VMS, but also
physical, psychosocial and sexual symptoms (p<0.01 on all
domains). With DARE-HRT1 use, vaginal pH significantly decreased
compared to baseline (p<0.01) and cytologic tests of the vaginal
epithelium (vaginal maturation index) showed significant
normalization (all p values <0.01 for increases in superficial
cells, increases in intermediate cells and decreases in parabasal
cells from baseline) among all participants. Finally, the most
common genitourinary symptom, vaginal dryness, which was reported
by 70% of participants at baseline, showed significant improvement
in both DARE-HRT1 groups (p<0.01) and this subset also
experienced significant decreases in vaginal pain with DARE-HRT1
use (p<0.01).
The study treatment was well tolerated with the types of most
common adverse events consistent with other vaginal products. There
were only two early discontinuations due to an adverse event, and
no serious adverse events were reported.
DARE-HRT1 had a high level of acceptability in the study, with
100% of subjects reporting that the IVR was comfortable to wear,
and there were no reports of the IVR being expelled from the vagina
during use. Additionally, over 95% of subjects stated they would be
either somewhat or very likely to use the IVR for a women’s health
condition or unrelated disease if needed.
"The safety findings in the study are reassuring in that they
are typical of what we would expect among menopausal users of a
vaginal ring,” said Dr. Christine Mauck, Medical Director of Daré
Bioscience and Medical Monitor of the DARE-HRT1 Phase 1 / 2 study.
“Notably, there are currently no FDA-approved intravaginal rings
for use by postmenopausal women that continuously deliver both
estradiol and progesterone together."
The topline PK data from the study will be available later in
the fourth quarter 2022 and will be announced at that time.
Daré plans to submit data from the Phase 1 / 2 clinical study of
DARE-HRT1 for publication in a peer-reviewed publication.
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 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 advantages
over oral routes of administration.2
- Menopause 101: A primer for the perimenopausal. NAMS,
accessed 15 October
2022. 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 BioscienceDaré 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 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 StatementsDaré 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,” “endeavor” 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 timing of topline PK data from the Phase
1 / 2 study of DARE-HRT1, the importance of the Phase 1 / 2
clinical study results to Daré and DARE-HRT1, and the anticipated
regulatory approval pathway for 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 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 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; 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; general industry conditions
and competition; general economic factors, including inflation,
rising interest rates and currency exchange rate fluctuations; the
impact of the ongoing COVID-19 pandemic; the impact of
pharmaceutical industry regulation and health care legislation in
the United States and internationally; global trends toward health
care cost containment; technological advances; new products and
patents attained by competitors; Daré’s future financial condition,
operating results and performance; Daré’s or its licensee’s ability
to accurately predict future market conditions; third-party
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; difficulties developing
and sustaining relationships with commercial counterparties;
dependence on the effectiveness of patents owned or licensed by
Daré and other protections for innovative products; and the
exposure of Daré, its commercial counterparties and other third
parties on which it relies to litigation, including patent
litigation, and/or regulatory actions. 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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