Dare Bioscience announces publication of data from Ovaprene study

Dare Bioscience announced the publication of data from the postcoital test clinical study of Ovaprene in two original research articles in the journal Contraception. “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 Dare 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(R) which aims to enroll sufficient participants across approximately 20 study sites in the U.S. to have approximately 250 participants complete approximately 12 months of use. Dare plans to provide updates on anticipated timing for study completion as enrollment progresses. If successful, Dare expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries. In July 2021, Dare entered into a Cooperative Research and Development Agreement 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, part of the National Institutes of Health to collaborate on the pivotal Phase 3 study of Ovaprene. The agreement gives Dare 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, Dare and Bayer announced an exclusive licensing agreement for U.S. commercial rights to Ovaprene. Under the agreement, Dare 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 Dare if Bayer, in its sole discretion, pays Dare $20 million. In addition, Dare 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.