Full Press Release Details
Bioscience Announces Additional Positive Data from Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women and Proposed Endpoints and
Patient Population for Phase 3 Program
Analyses of Phase 2b Data Conducted in Population of Study Participants with Female Sexual Interest/Arousal Disorder (FSIAD), With Primary
Complaint of Arousal Dysfunction
Statistical Significance and Clinically Meaningful Improvement in Phase 2b Co-Primary Endpoint Assessing Arousal Sensation, and Statistical
Significance in Items from Phase 2b Co-Primary Endpoint Scale Evaluating Concern Related to Difficulties with Sexual Arousal in Subset
Support Advancing Co-Primary Endpoints and Selected Patient Population from Phase 2b to Proposed Phase 3 Program
is On Track for End of Phase 2 Meeting with FDA This Year
Cream Has Potential to Be First FDA-Approved Treatment for Any Form of Sexual Arousal Disorder in Women
DIEGO, November 1, 2023 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation,
and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today
announced additional positive findings based on further analyses of data from the exploratory Phase 2b RESPOND study that evaluated Sildenafil
Cream, 3.6% (Sildenafil Cream) in women with female sexual arousal disorder (FSAD).
Phase 2b RESPOND study enrolled women with FSAD and included women who had sexual dysfunctions in addition to FSAD. Further analyses
of Phase 2b RESPOND study data identified a subset of study participants-women with FSAD as well as women with FSIAD whose primary
complaint was arousal dysfunction-that achieved statistically significant and clinically meaningful improvement in the Phase 2b
co-primary endpoint of evaluating the efficacy of Sildenafil Cream versus placebo cream as measured by change from baseline to the end
of the 12-week double-blind dosing period in the Arousal-Sensation Domain of the Sexual Function Questionnaire (p=0.04). In addition,
only the Sildenafil Cream treatment group in this subset, and not the placebo group, demonstrated clinically meaningful improvement at
the end of the 12-week period.
other co-primary objective of the Phase 2b RESPOND study was to evaluate the efficacy of Sildenafil Cream compared to placebo cream as
measured by the change from baseline to the end of the 12-week double-blind dosing period in the score for feeling concerned by difficulties
with sexual arousal utilizing the Female Sexual Distress Scale - Desire, Arousal, Orgasm (FSDS-DAO). Analyses of the same subset
of women in the Phase 2b RESPOND study (women with FSAD and women with FSIAD whose primary complaint was arousal dysfunction) demonstrated
that the Sildenafil Cream treatment group achieved statistically significant improvement in several FSDS-DAO questions, including regarding
guilt, stress, inadequacy, and embarrassment due to their sexual problems (p=0.02 to 0.05).
showing improvements in multiple aspects of the sexual experience, we believe that the further analyses of the Phase 2b RESPOND study
data support advancing the Phase 2b co-primary endpoints to our Phase 3 program and evaluating the efficacy of Sildenafil Cream in a
broader population of women-women with FSAD and FSIAD," said Sabrina Martucci Johnson, President and CEO of Dar Bioscience.
"The further analyses bolster our belief that Sildenafil Cream has the potential to successfully address the significant unmet
need of arousal disorder. We remain on track for an end of Phase 2 meeting to discuss these exciting findings with the FDA this year,
and look forward to potentially initiating the first ever Phase 3 pivotal study for the treatment of arousal disorder in women. We also
look forward to presenting these additional positive analyses at the upcoming meeting of the Sexual Medicine Society of North America
in San Diego later this month."
on data from the exploratory Phase 2b RESPOND study, demonstrating improvement in multiple facets of female sexual dysfunction, and because
there is no FDA-approved product for FSAD, as described in the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), or for
FSIAD, as described in the fifth edition of the Diagnostic and Statistical Manual (DSM-5), Sildenafil Cream has the potential to be a
first-in-category product.
Phase 2b RESPOND study was a first of its kind Phase 2b clinical study that included patient reported outcome (PRO) instruments to screen
eligible women 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 or FSIAD and
thus there are no efficacy endpoints that have been previously validated in Phase 3 pivotal studies for potential treatments for FSAD
or FSIAD. The Phase 3 study design for Sildenafil Cream, including primary and secondary efficacy endpoints and inclusion/exclusion criteria
for study participants, will be determined following discussions with the U.S. Food and Drug Administration (FDA), including the company's
end of Phase 2 meeting with the FDA.
FSAD, FSIAD and Sildenafil Cream, 3.6%
as described in the DSM-IV, is a condition characterized as 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, and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in
men. As with ED in men, FSAD is associated with insufficient blood flow to the genitalia.
is characterized in the DSM-5 as lack of, or significantly reduced, sexual interest and/or arousal for at least six months and the symptoms
must be severe enough to cause clinically significant distress. A woman must have three of the following six symptoms in order to receive
an FSIAD diagnosis: absent or reduced interest in sexual activity; absent or reduced sexual thoughts or fantasies; no or reduced initiation
of sexual activity, and typically unreceptive to a partner's attempts to initiate; absent or reduced sexual excitement or pleasure
in almost all or all sexual encounters; absent or reduced sexual interest/arousal in response to any internal or external sexual cues;
and absent or reduced genital or non-genital sensations during sexual activity in all or almost all sexual encounters. FSIAD can be lifelong
or acquired, range from mild to severe, and may be generalized or situational.
a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand
name Viagra for the treatment of ED in men. Sildenafil Cream is an investigational, proprietary cream formulation of
sildenafil designed for topical administration to the vulvar-vaginal tissue on demand 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.
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. In comparison,
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.
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, vaginal health, reproductive health,
menopause, sexual health and fertility.
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. Dar '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 (FSAD) and/or female sexual interest/arousal disorder (FSIAD)
utilizing the active ingredient in Viagra ; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal
ring for menopausal hormone therapy. 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.
Bioscience leadership has been named on the Medicine Maker's Power List and Endpoints News' Women in Biopharma 2022. In 2023,
Dar 's CEO was honored as one of Fierce Pharma's Most Influential People in Biopharma for Dar 's contributions
to innovation and advocacy in the women's health space. Dar Bioscience placed #1 in the Small Company category of the San
Diego Business Journal's 2023 Best Places to Work Awards.
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 X (formerly 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 Sildenafil
Cream's potential as a safe and effective therapy for FSAD and/or FSIAD, Dar 's plans for continued clinical development
of Sildenafil Cream, the potential primary endpoints and patient population to be evaluated in a Phase 3 clinical study, the timing of
an end of Phase 2 meeting with the FDA related to Sildenafil Cream, the potential for Sildenafil Cream to be the first FDA-approved treatment
for any form of sexual arousal disorder in women, and the potential market opportunity for Sildenafil Cream. 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