Daré Bioscience announced the receipt of a $6 million non-dilutive funding installment under its multi-year grant agreement to support development of DARE-LARC1, bringing the total received to approximately $37.8 million of up to approximately $49 million in committed grant funding. The funding supports nonclinical development, IND-enabling studies, and preparation for submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).
Revolutionary Drug Delivery Technology
DARE-LARC1 represents a preclinical-stage investigational, long-acting reversible contraceptive (LARC) utilizing a next-generation programmable drug delivery device to administer levonorgestrel, the active pharmaceutical ingredient in a number of FDA-approved birth control methods, for an extended period without requiring day-to-day effort.
The underlying DARE-IDDS (intelligent drug delivery system) platform was originally developed at the Massachusetts Institute of Technology by renowned inventors Dr. Robert Langer and Dr. Michael Cima. Clinical proof of concept was validated with an earlier prototype in a prior human study in osteoporosis patients, establishing the feasibility of long-term, programmable drug release via an implantable device.
Since acquiring the technology, Daré has advanced the design by enhancing electronics, battery performance, and precision dosing, guided by therapeutic use cases and user feedback. The result is a programmable, wirelessly controlled device capable of delivering up to hundreds of individualized doses over months or years, without recharging or surgical replacement.
Advanced Platform Features
The DARE-IDDS platform incorporates several cutting-edge capabilities:
- Precision Dosing: Controlled release via programmable micro-reservoirs
- Extended Duration: Monthly to multi-year dosing capability from a single device
- No External Power Required: Implant-grade battery designed to last up to 20 years
- Remote Programmability: Schedules and dosing parameters adjustable wirelessly in real time
- Smartphone Integration: Custom mobile apps for user and clinician interface
- Upgradable Firmware: Software updates extend lifecycle without device removal
Broad Therapeutic Applications
While the initial focus is DARE-LARC1 for contraception, the flexible DARE-IDDS platform supports integration with GLP-1 analogs, anti-obesity medications, hormone therapies for areas such as diabetes, breast cancer, and infertility, and neurologic disease treatments such as for Parkinson's disease.
"Beyond reproductive health, this platform has the potential to dramatically improve patient adherence, reduce treatment burden, and lower healthcare system costs in areas that today rely on frequent injections or daily oral dosing," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
Strategic Development Path
"This funding milestone will help advance what we believe is one of the most promising smart drug delivery technologies in development today," Johnson stated. "With non-dilutive capital covering early development, we are not only progressing a novel contraceptive, but also laying the foundation for a versatile, programmable drug delivery device platform across high-value therapeutic areas."
Daré is eligible for continued non-dilutive funding installments of up to approximately $11.2 million, contingent on achieving technical and other milestones specified in the grant agreement. The company is actively exploring strategic collaborations to expand the investigation of the DARE-IDDS platform into additional therapeutic categories and expects to continue providing updates on program progress and partnership activity.
The DARE-IDDS platform represents a significant advancement in drug delivery technology, with potential applications spanning multibillion-dollar markets including obesity, diabetes, and other chronic conditions that require precise, programmable, and long-term dosing regimens.