Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced topline PK results from its Phase 1 / 2
clinical trial of DARE-HRT1 that support the potential of DARE-HRT1
as an effective hormone therapy (HT) based on the levels of
hormones released. 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 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. 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.
“The delivery of hormone therapy over a 12-week study via a
28-day intravaginal ring which requires 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,” said Dr.
Annie Thurman, Medical Director of Daré Bioscience. “We believe
these Phase 1 / 2 topline data support progressing directly into a
single Phase 3 study following the Investigational New Drug (IND)
submission to and clearance from the FDA.”
Previously reported topline efficacy data from the Phase 1 / 2
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.
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 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 (estradiol 80
µg/progesterone 4 mg IVR and estradiol 160 µg/progesterone 8 mg
IVR) 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
Topline data from the study demonstrate that DARE-HRT1
successfully delivered estradiol and progesterone over the 12-week
evaluation period. The baseline-corrected steady state release of
estradiol and progesterone from both the lower (IVR1) and higher
(IVR2) dose versions of DARE-HRT1 evaluated in the study
demonstrated steady state release levels in month 3 of the 12-week
study as shown in the table below:
|
Steady State Cavg (standard deviation) |
DARE-HRT1 IVR1 (n=11) |
|
Estradiol |
22.17 (4.47) pg/mL |
Progesterone |
1.25 (0.34) ng/mL |
DARE-HRT1 IVR2 (n=10) |
|
Estradiol |
38.97 (10.79) pg/mL |
Progesterone |
1.80 (0.28) ng/mL |
The levels of estradiol released from both the lower and higher
dose formulation of DARE-HRT1 evaluated in the study achieved or
exceeded the levels that were targeted for hormone therapy. Target
levels of estradiol for hormone treatment for either the VMS or
vaginal symptoms of menopause were established by reviewing PK
levels published for FDA-approved products for both the treatment
of VMS as well as the genitourinary symptoms of menopause. Based on
the estradiol PK data in the DARE-HRT1 Phase 1 / 2 study, the
results support the potential of DARE-HRT1 as an effective hormone
therapy for both VMS and vaginal symptoms associated with
menopause. The levels of progesterone released from both versions
of DARE-HRT1 evaluated in the study met the objectives of releasing
progesterone. Progesterone is used in hormone therapy to reduce the
impact of estrogen on nontarget sites, such as the endometrium, to
prevent estrogen-induced endometrial hyperplasia.
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.
Daré plans to submit data from the Phase 1 / 2 clinical study of
DARE-HRT1 for publication in a peer-reviewed publication.
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 advantages
over oral routes of administration.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 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 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 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,” 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 Phase 1 / 2 clinical
study results 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.com 212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake
RobisonEvoke
Canalejake.robison@evokegroup.com 619.849.5383
Source: Daré Bioscience, Inc.
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