Daré Bioscience’s DARE-LARC1 Platform Technology Achieves Proof-of-Concept Device that has Transformative Potential for Women’s Health as well as in Treating a Broad Range of Diseases
The technology behind this drug delivery platform was originally developed at the
“The team has made incredible progress in the last 12 months, culminating with fully integrated and functional test devices that will be used for IND enabling studies,” said
“We are excited to have reached this meaningful inflection point in the DARE-LARC1 program and see the potential that this technology has to reshape the long-acting contraceptive category in women’s health, as well as its potential to transform treatment for certain chronic conditions,” said
To support development opportunities outside of the reproductive health category, including diabetes, obesity, and other conditions requiring precise and prolonged treatment, Daré plans to begin strategic discussions with potential industry partners.
Daré is currently developing the platform technology internally with funding from a foundation grant in DARE-LARC1, a potential new class of long-acting, reversible contraceptive (LARC). If successful, DARE-LARC1 could provide women with unparalleled control over the management of their fertility to better meet specific individual family planning goals and objectives. As with other types of LARC products, investigational DARE-LARC1 is intended to provide effective contraception for an extended period without requiring day-to-day effort. Unlike current LARC products, DARE-LARC1’s innovative features include precision dosing, extended device duration and wireless control. DARE-LARC1 utilizes levonorgestrel, which is the active pharmaceutical ingredient in a number of FDA-approved birth control methods.
Key features of the implant technology include:
- Precision dosing: Unique design allows for precise dose timing and amount using individually addressable drug micro-reservoirs.
- Extended duration and dosing interval control: The ability to house up to hundreds of individual doses means a single device can provide dosing over months to years.
- No external charging or recharging required: A custom implant grade battery is designed to last for up to 20 years, depending on the application.
- Upgradable platform: Device software can be updated without removal or replacement of the implant.
- Two-way communication: Smart technology can respond wirelessly to queries from an external communication device to provide status updates, modify dosing, and deliver other application specific information.
- Smartphone integration: Platform can be paired with custom mobile apps designed for each application to create a personalized experience for the user.
About Daré Bioscience
Daré 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.
Daré’s 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. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose
Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in
Daré 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),
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,” “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 DARE-LARC1’s potential as a safe and effective LARC product, the potential market opportunity for DARE-LARC1, if approved, the potential of the drug delivery platform underlying DARE-LARC1 to be utilized in products for the treatment of a broad range of diseases and conditions, and the potential for Daré to enter into strategic collaborations relating to the drug delivery platform. 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, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; 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; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; 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 the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or 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 and product candidates; 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; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in
Media and Investors on behalf of Daré Bioscience, Inc:
Camilla White / Simona Kormanikova
DareBioscience@dentonsglobaladvisors.com / 1.212.466.6450
Source: Daré Bioscience, Inc.
Source: Daré Bioscience, Inc.