Takeaways
- Phase 3 Initiated: Daré Bioscience begins a phase 3 trial for ovaprene, a hormone-free monthly contraceptive showing efficacy in preventing sperm entry.
- Mechanism: Ovaprene employs a locally acting agent to reduce sperm motility, validated in postcoital test studies.
- Study Overview: The pivotal 12-month phase 3 trial involves 250 participants, assessing ovaprene's long-term safety and efficacy.
- Exclusive Licensing: Daré and Bayer hold an exclusive licensing agreement, granting Bayer commercial rights in the US upon trial completion.
- Collaboration and Innovation: A CRADA with the US Department of Health and Human Services involves cost-sharing and provides Daré access to NICHD's contraceptive trial expertise.
A phase 3 clinical trial of ovaprene has been initiated, according to Daré Bioscience.
Ovaprene is an intravaginal, hormone-free contraceptive that is administered once per month. It releases a locally acting agent to reduce sperm motility and prevent sperm from entering the cervical canal. In a postcoital test (PCT) clinical study, ovaprene showed efficacy in keeping sperm out of the cervical canal, supporting further clinical development.
The long-term safety and efficacy of ovaprene will be assessed in the multi-center, single arm, non-comparative, pivotal phase 3 study. The study plans to include approximately 250 participants across 20 study sites, who will use ovaprene for approximately 12 months.
Daré and Bayer entered an exclusive licensing agreement for commercial rights to ovaprene. After completion of the clinical trial conducted by Daré, Bayer will have exclusive commercial rights for ovaprene in the United States.
In 2021, Daré and the US Department of Health and Human Services initiated a Cooperative Research and Development Agreement (CRADA) to collaborate on the phase 3 trial. The CRADA has the National Institute of Child Health and Human Development (NICHD) share the cost of the study with Daré and provides Daré with access to contraceptive clinical trial expertise from the NICHD clinical trial network.
"We're excited about Daré’s announcement of commencement of the pivotal Phase 3 clinical trial for Ovaprene,” said Yesmean Wahdan, MD, vice president, US Medical Affairs Women’s Healthcare at Bayer. “It is extremely important that we continue to innovate and strive to address women’s unmet medical needs and wants, especially as it relates to contraceptive options.”
If the phase 3 trial is successful, Daré believes the results will support approvals in the United States and other countries for marketing ovaprene. If the FDA approves ovaprene, it will be the first monthly non-hormonal contraceptive product for women.
Reference:
Daré Bioscience announces commencement of phase 3 study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive. Daré Bioscience. December 4, 2023. Accessed December 5, 2023. https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-commencement-phase-3-study-ovaprener
