Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s
health innovation, today announced positive topline results from
its Phase 1 clinical trial of DARE-HRT1. DARE-HRT1 is a novel 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 to treat the vasomotor symptoms (VMS) and
genitourinary syndrome associated with menopause. The topline data
from the study support DARE-HRT1’s 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 to treat both VMS as well as
vaginal symptoms of menopause. The North American Menopause
Society’s guidance on hormone therapy includes 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 the ability to deliver
two different active pharmaceutical ingredients, in this case two
bio-identical hormones, reliably over a 28-day period. Generating
positive topline data in our first Phase 1 study utilizing our
novel IVR technology represents an important clinical achievement
for Daré and for the IVR platform,” said Sabrina Martucci Johnson,
President and CEO of Daré Bioscience. “For some women, hormone
therapy is a highly effective treatment for the symptoms associated
with menopause, such as hot flashes and vaginal dryness, and may
also prevent bone loss and fracture. 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.”
“We are highly encouraged by these Phase 1 data
as they demonstrate DARE-HRT1’s ability to achieve our dual release
objectives,” said David Friend, PhD, Chief Scientific Officer of
Daré Bioscience. “In addition to delivering hormone therapy, we
believe the IVR technology used in DARE-HRT1 is an important
platform technology with the potential to offer a versatile vaginal
drug delivery solution to address a variety of unmet needs in
women’s health through its ability to release one or more drugs at
desired rates over time and with the added benefit of
convenience.”
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 vaginal
ring 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.
DARE-HRT1 Phase 1 Clinical Trial Study
Design
The randomized, open-label, three-arm, parallel
group Phase 1 study was designed to evaluate the pharmacokinetics
(PK) of DARE-HRT1 in approximately 30 healthy, post-menopausal
women with intact uteri. The primary objective of the study was to
describe the PK parameters of two different dose combinations over
28 days. Secondary objectives of the study were to assess the
safety and tolerability of DARE-HRT1 and to compare the systemic
exposure of estradiol (the active form for therapeutic hormone
therapy purposes), estrone, and progesterone of DARE-HRT1 over 28
days against a daily combination of FDA-approved oral estrogen and
oral progesterone products evaluated in the Phase 1 study.
The study was conducted by the company’s wholly
owned subsidiary in Australia.
Topline Results of the Phase 1 Clinical
Trial
Data from the study demonstrate that DARE-HRT1
successfully delivered estradiol and the progesterone over the
28-day 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 over 28 days as shown in
the table below:
|
Steady State (Standard Deviation) |
DARE-HRT1 IVR1 (n=10) |
|
Estradiol |
20.6 (16.8) pg/mL |
Progesterone |
1.32 (0.20) ng/mL |
DARE-HRT1 IVR2 (n=11) |
|
Estradiol |
32.5 (9.3) pg/mL |
Progesterone |
2.23 (0.61) 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 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.2
In addition, the study treatment was well
tolerated with the most common adverse events consistent with other
vaginal products. There was only one early discontinuation due to
an adverse event, which was found to be unrelated to study
treatment or participation, and no serious adverse events were
reported. The proportion of participants reporting adverse events
was similar across all dose groups, the two DARE-HRT1 groups as
well as the group receiving a daily combination of FDA-approved
oral estrogen and oral progesterone products, with 89% of adverse
events mild in severity and all other adverse events (11%) rated as
moderate.
DARE-HRT1 had a high level of acceptability in
the study, with over 80% of subjects on the lower and higher dose
versions of DARE-HRT1 reporting the IVR as comfortable or very
comfortable. Additionally, over 80% of subjects in each IVR dose
group stated they were either somewhat or very likely to use the
IVR for a women’s health condition or disease if needed. Daré plans
to submit data from the Phase 1 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 FDA’s 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 58.3 An estimated 45 million women in the U.S.
are approaching or in menopause, which results in a decrease in
estrogen and other hormones.1,3 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.3 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.1
- The NAMS 2017 Hormone Therapy Position Statement Advisory
Panel. The 2017 hormone therapy position statement of The North
American Menopause Society. Menopause. 2017 Jul;24(7):728-753. DOI:
10.1097/GME.0000000000000921
- Kuhl, H. (2005) Pharmacology of estrogens and progestogens:
influence of different routes of administration. Climacteric,
8:sup1, 3–63. DOI: 10.1080/13697130500148875
- Menopause 101: A primer for the perimenopausal. NAMS, accessed
25 June 2021.
http://www.menopause.org/for-women/menopauseflashes/menopause-symptoms-and-treatments/menopause-101-a-primer-for-the-perimenopausal.
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 product portfolio includes potential
first-in-category candidates in clinical development: Ovaprene®, a
novel, investigational 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®; 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 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 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 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 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. 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
monthly therapy for VMS and vaginal symptoms of menopause, the
potential of Daré’s IVR technology to provide a platform for
development of other vaginally delivered therapies, the importance
of the Phase 1 clinical study results to Daré, DARE-HRT1 and the
IVR platform, 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 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:
the risk that topline results from a clinical trial, including the
Phase 1 study of DARE-HRT1, are based on Daré’s preliminary
analysis of key data and, following a comprehensive review of study
data, such results may change and topline results may not
accurately reflect the complete results from the clinical trial;
the risk that the FDA, other regulatory authorities or members of
the scientific or medical communities may not accept or agree with
Daré’s interpretation of or conclusions regarding the study data;
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
FDA or foreign regulatory approval for Daré’s product candidates in
a timely manner; 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; 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 risk that developments
by competitors make Daré’s product candidates less competitive or
obsolete; failure of Daré’s product candidates, if approved, to
gain market acceptance or obtain adequate coverage from third-party
payers; 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;
Daré’s failure to timely establish or leverage third-party
partnerships or collaborations to commercialize its product
candidates, if approved; 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; cyberattacks,
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.
Contact
Media contact:Lisa Walters-Hoffert, Chief
Financial Officer Daré Bioscience,
Inc.lwalters@darebioscience.com858.926.7655
Investors on behalf of Daré Bioscience, Inc.:Tom
MastersonAllele Capital
Partnerstmasterson@allelecapital.com646.573.3216
Source: Daré Bioscience, Inc.
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