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Published data shows that Ovaprene was safe and effective in a postcoital test study of 33 women
Pivotal Phase 3 contraceptive efficacy clinical study of Ovaprene currently enrolling
Ovaprene has the potential to be the first FDA-approved hormone-free monthly intravaginal contraceptive for women
SAN DIEGO, April 11, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced the publication of data from the postcoital test clinical study of Ovaprene in two original research articles in the journal Contraception.
Publication Details:
Mauck, et al. "Successful postcoital testing of Ovaprene: An investigational non- hormonal monthly vaginal contraceptive." Contraception. Vol. 132, April 2024, 110373. https://doi.org/10.1016/j.contraception.2024.110373
Mauck, et al. "Safety Testing of Ovaprene: an Investigational Non-Hormonal Monthly Vaginal Contraceptive." Contraception. Advance online publication, 110440. https://doi.org/10.1016/j.contraception.2024.110440
"We are very pleased to have the postcoital test study results for our investigational, hormone-free intravaginal contraceptive Ovaprene published in a leading reproductive health journal," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "Our published results show Ovaprene was safe and prevented essentially all sperm from entering the cervical canal across all women and cycles evaluated without disrupting the vaginal microbiome. PCT studies have been used as surrogate markers for contraceptive effectiveness and, based on comparable PCT studies, Ovaprene is expected to deliver efficacy approaching hormonal methods. The published results were seminal in enabling us to commence the pivotal Phase 3 clinical study of Ovaprene, which is now enrolling across the United States as we continue to advance this innovative candidate for women who want or need a hormone-free contraceptive."
The pivotal study is a single arm, open-label contraceptive efficacy study of Ovaprene® which aims to enroll sufficient participants across approximately 20 study sites in the U.S. to have approximately 250 participants complete approximately 12 months (13 menstrual cycles) of use. Daré plans to provide updates on anticipated timing for study completion as enrollment progresses. If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries.
In July 2021, Daré entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), to collaborate on the pivotal Phase 3 study of Ovaprene. The agreement gives Daré access to the contraceptive clinical trial expertise of NICHD's Contraceptive Clinical Trial Network while also sharing the costs of the Phase 3 pivotal study with NICHD.
In January 2020, Daré and Bayer announced an exclusive licensing agreement for U.S. commercial rights to Ovaprene. Under the agreement, Daré received an upfront payment and access to Bayer's extensive clinical and market capabilities while retaining control over Ovaprene's development and regulatory approval process. Bayer received the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Daré if Bayer, in its sole discretion, pays Daré $20 million. In addition, Daré may receive from Bayer up to $310 million in commercial milestone payments, plus double-digit, tiered royalties on net sales.
If Ovaprene is approved by the FDA, it could be the first monthly hormone-free contraceptive product for women and a first-in-category option for women seeking a hormone-free, self-administered and monthly birth control method.
Posted In: DARE
