Full Press Release Details
Bioscience Announces Positive Efficacy Results from the DARE-HRT1 Phase 1 / 2 Study
Significant Results for Improvement in both the Vasomotor and the Vaginal Symptoms of Menopause
has the potential to be the first FDA-approved monthly intravaginal ring delivering both estrogen and progestogen hormone therapy
DIEGO, October 17, 2022 (GLOBE NEWSWIRE) - Dar 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 17 -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.
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 Dar 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."
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, Dar '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.
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.
Phase 1 / 2 Clinical Trial Study Design
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.
study was conducted by Dar 's wholly owned subsidiary in Australia.
Results of the Phase 1 / 2 Clinical Trial
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.
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).
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.
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.
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 Dar 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
topline PK data from the study will be available later in the fourth quarter 2022 and will be announced at that time.
plans to submit data from the Phase 1 / 2 clinical study of DARE-HRT1 for publication in a peer-reviewed publication.
clinical development, Dar 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
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
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
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. Dar '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 , Dar 's full
portfolio of women's health product candidates, and Dar 's mission to deliver differentiated therapies for women,
please visit www.darebioscience.com.
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. Dar
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 Dar
posts on its investor relations website or through social media channels may be deemed to be material information. Dar encourages
investors, the media, and others interested in the company to review the information Dar 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 Dar 's website.
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 Dar
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 Dar '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