Full Press Release Details
Bioscience Announces Interim Analysis of Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder
Enrollment Expected to Complete in 4Q-2022 with Approximately 150 Subjects
Data of Phase 2b RESPOND Study Targeted for 2Q-2023
clinical development is successful, Sildenafil Cream, 3.6% has the potential to be the first FDA-approved FSAD treatment option
DIEGO, August 29, 2022 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation,
and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced that,
based on the results of an interim analysis to evaluate the relative magnitude of the treatment effect, they expect to complete enrollment
in the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in 4Q-2022, allowing for a topline data announcement target
of 2Q-2023. The interim analysis was conducted by an independent third-party statistical resource and both Dar and SST continue
to remain blinded to results of the study by treatment group. The Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled
study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD).
Cream is a proprietary topical formulation of sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, being developed as a first-in-category
option for the treatment of FSAD. FSAD is the inability to reach or maintain a sufficient physical response to sexual stimulation and,
of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. Sildenafil is
the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra for the treatment of ED
are thrilled to have reached this important milestone for this study this year and look forward to evaluating the topline data next year,"
said Sabrina Martucci Johnson, President and CEO of Dar Bioscience. "Although numerous pharmaceutical products have been
developed, tested and approved by the FDA to treat ED in men, there are no FDA-approved options for women with FSAD, an analogous condition.
Completing this Phase 2b study will be a significant milestone in the development of what has the potential to be the first FDA-approved
product to treat FSAD. Based on the relative treatment effect seen in the interim analysis we are comfortable with an enrollment target
of 150 women completing the study, and believe these Phase 2b data will facilitate ongoing discussion and future alignment with the FDA
regarding the pivotal registration program."
the oral formulations of PDE-5 inhibitors, Sildenafil Cream is designed to be applied locally to the vaginal tissue prior to sexual activity
to facilitate vasodilation and increased blood flow directly to the genital tissue to improve the physical arousal response symptoms
commonly associated with FSAD. Increasing blood flow to the genital tissue, as Sildenafil Cream is designed to do, has the potential
to improve genital arousal response and overall sexual experience for women. This is similar to the way ED medications work in men by
directing blood flow to the genitals when taken prior to sexual activity.
Phase 2b RESPOND study evaluates Sildenafil Cream compared to a placebo cream in pre- and peri-menopausal women over the course of 12
weeks, in an at-home setting, following both a non-drug and placebo cream run-in period. The Phase 2b RESPOND study is a first of its
kind Phase 2b study that includes patient reported outcome (PRO) instruments to screen eligible women with FSAD and a number of primary,
secondary, and exploratory PRO assessments to measure improvement in localized genital sensations of arousal and reduction in the distress
that women experience with FSAD. There are no FDA-approved treatments for FSAD and thus there are no efficacy endpoints that have been
previously validated in Phase 3 pivotal studies for potential treatments for FSAD. The RESPOND study is designed to test the sensitivity
of several efficacy endpoints and their ability to determine a treatment effect of Sildenafil Cream compared to placebo to inform the
ongoing development program. The independent third-party statistical resource was provided with unblinded data in order to determine
the relative magnitude of the treatment effect to enable a determination of next steps with study enrollment and enrollment targets.
research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from experiencing symptoms
associated with FSAD, including lack of or low sexual arousal, and are actively seeking solutions to improve their condition. For context
on the potential market opportunity for an FDA-approved treatment for FSAD, the prevalence of complete ED in men is estimated to be about
5% of men at age 40, increasing to about 15% at age 70.
is distinct from hypoactive sexual desire disorder (HSDD) in women, which is characterized primarily by a lack of sexual desire. FSAD
is a condition characterized primarily by a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate
lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty. As with ED in men,
FSAD is associated with insufficient blood flow to the genitalia.
Sildenafil Cream, 3.6% and the Phase 2b RESPOND Study
Cream is an investigational proprietary cream formulation of sildenafil, a PDE-5 inhibitor, designed for topical administration to the
vulva and vagina to increase genital blood flow and provide improvements in the female genital arousal response, while avoiding systemic
side effects observed with oral formulations of sildenafil. Sildenafil Cream has been previously evaluated in Phase 1 and Phase 2a clinical
studies. In a Phase 1 clinical study in 20 healthy post-menopausal women, topical sildenafil cream was safe and well tolerated at clinically
relevant doses, and study subjects reported favorable product characteristics: easy to use and readily absorbed. In a Phase 2a study
in women with FSAD (15 pre-menopausal and 16 post-menopausal), Sildenafil Cream increased measurable blood flow to the genital tissue
compared to placebo cream. Further, data from a thermography study in six healthy women demonstrated significantly greater increases
in genital temperature after administration of Sildenafil Cream compared to placebo cream, indicating a positive impact on genital blood
flow during the 30-minute testing session, with statistical separation from placebo within the first 15 minutes of dosing.
to commencement of the Phase 2b RESPOND clinical study of Sildenafil Cream, Dar completed a content validity study designed to
identify and document the genital arousal symptoms that are the most important and relevant to women with FSAD. The findings of that
non-interventional study helped facilitate alignment with the FDA on acceptable efficacy endpoints for the Phase 2b RESPOND study and
future Phase 3 program, including a number of exploratory endpoints identified in the content validity study. The primary efficacy endpoint
of the Phase 2b study is a composite endpoint that includes patient-reported improvement in genital sensations of arousal and reduction
in distress associated with FSAD. While the Phase 2b RESPOND study was originally expected to randomize a minimum of 400 subjects into
the double-blind dosing period from 40 to 50 sites in the U.S. to achieve 150 subjects per arm completing the 12-week double-blind dosing
period, based on the analysis of unblinded data by the independent third-party statistical resource to evaluate the relative magnitude
of the treatment effect, it was determined to complete enrollment in 4Q-2022 with a revised projected 150 subjects expected to complete
the 12-week double-blind dosing period (approximately 75 subjects per arm). The reduction in the number of subjects should not be viewed
as indicative of the magnitude of the treatment effect. The relative magnitude of the treatment effect seen in the interim analysis should
not be viewed as predictive that topline data will show Sildenafil Cream achieved the efficacy endpoints of the Phase 2b study.
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. Dar 's first FDA-approved product, XACIATOTM (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," 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 the
timing of the completion of enrollment in the Phase 2b RESPOND clinical study and of the topline data announcement, the potential of
Sildenafil Cream, 3.6% to be approved by the FDA, and the market potential of Sildenafil Cream, 3.6%, if approved by the FDA . 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 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 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; Dar '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