Daré Bioscience Announces Grant to Develop Novel Hydrogel Formulation for Delivery of Live Biotherapeutics to Support Vaginal Health

Daré Bioscience, Inc. recently announced it has received a grant from the Bill & Melinda Gates Foundation of $584,986 to support activities related to development of a vaginal thermosetting gel formulation for the delivery of live biotherapeutics that can be reconstituted at the point of care. If successful, the formulation could be carried forward for further development as a delivery vehicle with potential to enhance the availability of novel therapeutics for vaginal health in the US and worldwide, including in countries with varying climatic conditions and/or where extended storage may be required.

Vaginal health conditions, such as bacterial vaginosis, remain prevalent and serious problems that can negatively impact a woman’s quality of life and create economic burden for women, employers, and the broader healthcare system. Scientific evidence suggests that there may be benefits to following an effective primary bacterial infection treatment with administration of live bacterial cultures to rebalance the vaginal microbiota disrupted by the infection. It is believed that addressing the vaginal dysbiosis by reconstituting the vaginal microbiota could reduce recurrence and reduce susceptibility to other infections and conditions, including sexually transmitted infections and preterm labor and birth. A barrier to development of live biotherapeutic products for vaginal administration in low and middle income countries is the identification of a delivery vehicle capable of maintaining the viability of the live microbes during product storage, shipment and distribution.

“One of Daré’s top priorities is to accelerate the development of differentiated products that can not only improve outcomes but increase access and convenience for women,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “We previously demonstrated the ability of a novel hydrogel technology to effectively deliver an active pharmaceutical ingredient vaginally through the development and approval of XACIATO (clindamycin phosphate) vaginal gel, 2%, our FDA-approved treatment for bacterial vaginosis in females 12 years of age and older for which global commercialization rights have been licensed to Organon. However, there remains a clear and unmet need for products that can be administered following effective treatment of the primary vaginal infection to then rebalance the vaginal microbiota and promote continued improved vaginal health. This grant will enable us to investigate the use of a novel hydrogel technology to deliver live biotherapeutics to address this challenge that affects women everywhere. We are grateful for the foundation’s support in advancing this technology with the goal of making such therapies available to women worldwide.”

On December 7, 2021, Daré announced the US FDA approved the company’s first application of a hydrogel technology with the approval of XACIATO (clindamycin phosphate) vaginal gel, 2% for the treatment of bacterial vaginosis in females 12 years of age and older.  On June 30, 2022, Daré announced that the exclusive license agreement entered into on March 31, 2022 with Organon, a global women’s healthcare company, became fully effective. Under the agreement, Organon licensed global rights to XACIATO. The first commercial sale of XACIATO is anticipated in the first half of 2023 in the US

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, fertility, and vaginal and sexual health.

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. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose US 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 utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. For more information, visit www.darebioscience.com.