SAN DIEGO, Jan. 04, 2024 -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that it has achieved technological proof of concept for DARE-LARC1 and the underlying innovative drug delivery platform designed to store and precisely deliver therapeutic doses over months or years through a single device. This milestone reflects the drug delivery platform’s potential to address the treatment burden for various conditions where treatment requires frequent dosing or regular injections.

The technology behind this drug delivery platform was originally developed at the Massachusetts Institute of Technology by renowned researchers Robert Langer, Ph.D. and Michael J. Cima, Ph.D. and was previously validated in a first-in-human study in osteoporosis patients using an earlier prototype. Daré has since made significant technological enhancements to the design and integration of custom electronics, hardware, and software to achieve drug delivery targets while incorporating user feedback to optimize form and function. Daré’s progress has resulted in a highly versatile platform technology with potential to address meaningful unmet needs in reproductive health as well as other therapeutic areas including diabetes, obesity, and other conditions requiring precise and prolonged treatment.

“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 Elizabeth Proos, Vice President, Product Development of Daré Bioscience. “We believe that we have realized a true technological achievement with this platform, and we are excited to be one step closer to human clinical trials.”

“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 Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “With potential to be the first and only contraceptive device that can be paused and resumed by the user, it will offer the convenience of short-acting methods with the security of long-acting methods. The technological development milestones we achieved over the past year in particular position us to now begin strategic discussions with pharmaceutical companies working to address chronic conditions, including metabolic disorders, leveraging the platform’s potential to precisely deliver a wide array of active pharmaceutical ingredients over longer durations with a lower burden for patients.”

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.

Reference: Click Here