Full Press Release Details
Dar Bioscience, Inc. Announces Enrollment in Thermography Feasibility
Study with Sildenafil Cream, 3.6%, a Potential Therapy for Female Sexual
Sildenafil Cream, 3.6% has
the Potential to Receive the First FDA Approval
for Female Sexual Arousal Disorder
SAN DIEGO, Nov. 27, 2018 (GLOBE NEWSWIRE) -- Dar Bioscience, Inc. (NASDAQ: DARE), a leader in
clinical-stage women s health innovation, today announced that it is currently enrolling patients in an investigational study designed to evaluate the feasibility of using thermography technology to assess the pharmacodynamics of Sildenafil
Cream, 3.6% in normal healthy women. Sildenafil, the active ingredient in Sildenafil Cream, 3.6%, is marketed in an oral dosage form under the brand name Viagra for the treatment of erectile
dysfunction in men. Dar Bioscience, in partnership with Strategic Science & Technologies, LLC (SST), is developing Sildenafil Cream, 3.6% as a potential treatment for female sexual arousal disorder (FSAD). During the
thermography study, genital temperature, a surrogate for genital blood flow, will be captured and recorded utilizing an infrared camera capable of detecting heat patterns from blood flow in body tissues. The study consists of the screening visit
(visit 1), the double-blind dosing of placebo or active cream (visits 2-3) and a safety follow-up.
We are excited to announce that enrollment is underway in this thermography study, said Sabrina Martucci Johnson, President & CEO of Dar
Bioscience. This study is part of our larger FSAD development program, and reflects capital-efficient activities we are pursuing to enrich and enhance the Phase 2b program. This small exploratory study has the potential to provide greater
insight into the physiologic activity and time to effect resulting from the application of Sildenafil Cream, 3.6% externally to the vulva and internally in the vagina, which would further inform and support the design of our Phase 2b at-home study, anticipated to commence in 2019.
Sildenafil Cream, 3.6% is a proprietary cream formulation specifically
designed to increase blood flow to the genital tissue in women, leading to a potential improvement in genital arousal response during sexual activity. If successful, Sildenafil Cream, 3.6% has the potential to be the first FDA-approved FSAD treatment option.
The thermography study is part of a comprehensive clinical development and regulatory
strategy that includes an upcoming content validity study to support the implementation of FSAD specific patient reported outcome (PRO) instruments, as well as an at-home dosing study which together constitute
our Phase 2b program, said Mary Jarosz, Global Head of Regulatory Affairs for Dar Bioscience.
The principal investigator for the thermography study is
Dr. Irwin Goldstein, a recognized leader in the treatment of both male and female sexual disorders and the 2009 recipient of the World Association for Sexual Health Gold Medal award in recognition of lifetime contributions to the field.
We are pleased to be working with SST and Dar on the Sildenafil Cream, 3.6% program, leveraging the known therapeutic
benefit of Viagra to stimulate increased blood flow to the genital tissue, said Dr. Goldstein. There are no approved drugs for the treatment of FSAD and Sildenafil
Cream, 3.6% has the potential to be an on-demand solution to prepare the body for a more pleasurable sexual experience.
About Sildenafil Cream, 3.6% and 3Q2018 Type C Meeting with the FDA
Sildenafil Cream, 3.6% has the potential to be the first FDA-approved FSAD treatment option. Unlike other female sexual
disorders, FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal that causes distress or interpersonal difficulty. It is the closest analog in women to erectile dysfunction in men. While increased
attention has been focused on female sexual dysfunction over the past several years, no pharmacologic options have yet been U.S. Food and Drug Administration (FDA) approved for FSAD. In a Phase 2a trial, Sildenafil Cream, 3.6% increased measurable
blood flow to the vaginal tissue in both pre- and postmenopausal women with FSAD compared to placebo.
quarter of 2018, we had a Type C meeting with the FDA regarding the Phase 2b program for Sildenafil Cream, 3.6%. The objective of this meeting was to align with the agency on key aspects of the Phase 2b and the overall clinical program to support
the planned New Drug Application, or NDA, including the screening assessments used to accurately diagnose FSAD, the PRO instruments to be used as primary efficacy endpoints for pivotal clinical studies, study duration, and the target patient
population to be studied.
Based on the outcome of this meeting, in the fourth quarter of 2018, we will commence Phase 2b related activities for Sildenafil Cream,
3.6% with the initiation of a content validity PRO study to demonstrate that the FSAD symptoms we plan to assess in our Phase 2b and our pivotal studies are the most important and relevant to our target patient population and are also acceptable
efficacy endpoints for the FDA. After the content validity PRO study is completed and before the Phase 2b at-home trial is initiated, we plan to request another Type C meeting to obtain the FDA s guidance
on whether it agrees that the PRO instruments are content valid for the target population.
About Dar Bioscience
Dar Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women s reproductive and sexual health.
The company s mission is to identify, develop and bring to market a portfolio of novel, differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women in the areas of contraception, vaginal health,
sexual health, and fertility.
Dar s product portfolio includes two potential
first-in-class candidates in clinical development: Ovaprene , a
non-hormonal, monthly contraceptive vaginal ring, and Sildenafil Cream, 3.6%, a potential treatment for female sexual arousal disorder utilizing the same active ingredient as Viagra . To learn more about Dar s full portfolio of women s health products, and mission to deliver novel therapies for women, please visit www.darebioscience.com.
Dar may announce material information about its finances, product candidates, clinical trials and other matters
using its investor relations website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Dar uses these channels to communicate with its investors and the public about the company and other
company-related matters. The information Dar posts on its investor relations website may be deemed to be material information. Dar encourages investors, the media, and others interested in the company to review the information
Dar posts on its investor relations website.
Forward-Looking Statements
Dar 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. Such statements include, but are not limited to, statements relating to the potential of Sildenafil Cream, 3.6% to be the first FDA-approved FSAD
treatment option, the usefulness of the thermography study to clinical development and potential regulatory approval of Sildenafil Cream, 3.6% for FSAD, the timing of initiation or completion of the company s clinical studies, and the
company s ability to advance its product candidates through clinical development and regulatory approval. 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: our ability to raise additional capital when and as needed; our ability to develop and commercialize our product candidates; the failure or delay in starting, conducting and completing clinical trials or obtaining FDA or foreign
regulatory approval for our product candidates in a timely manner; our ability to conduct and design 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 efficacy of our product candidates; our ability to retain our licensed rights to develop and commercialize a product candidate; our ability to satisfy the monetary obligations and other
requirements in connection with our exclusive, in-license agreements covering the critical patents and related intellectual property related to our product candidates; developments by our competitors that make
our product candidates less competitive or obsolete; our dependence on third parties to conduct clinical trials; our ability to adequately protect or enforce our, or our licensor s, intellectual property rights; the lack of patent protection
for the active ingredients in certain of our product candidates which could expose our products to competition from other formulations using the same active ingredients; the risk of failure associated with product candidates in preclinical stages of
development that may lead investors to assign them little to no value and make these assets difficult to fund; and disputes or other developments concerning our intellectual property rights. Our forward-looking statements are based upon our 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 our risks and uncertainties, you are encouraged
to review our documents filed with the SEC including our 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. Dar 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.
Investors on behalf of Dar Bioscience, Inc.:
Media on behalf of Dar Bioscience, Inc.:
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Source: Dar Bioscience, Inc.