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Daré Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene®, an Investigational Hormone-Free Monthly Contraceptive
Funding and Clinical Operations Support will be Provided by the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Funding and Clinical Operations Support will be Provided by the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Under the CRADA Daré Plans to Submit an Investigational Device Exemption (IDE) to the FDA in the Fourth Quarter of 2021 and Commence the Ovaprene Pivotal Study in 2022 SAN DIEGO, July 12, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced that it entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), for the pivotal Phase 3 study of Ovaprene®, an investigational hormone-free monthly intravaginal contraceptive currently in clinical development for the prevention of pregnancy. The agreement will allow Daré to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD. If Ovaprene® is approved by the U.S. Food and Drug Administration (FDA), it could be the first monthly non-hormonal contraceptive option for women. The pivotal Phase 3 study will be supported by the NICHD’s Contraceptive Development Program (CDP). The CDP oversees the Contraceptive Clinical Trial Network (CCTN), which was established in 1996 to conduct studies of investigational contraceptives, and the Phase 3 study will be conducted within the CCTN with the NICHD contractor Health Decisions Inc. Daré will be responsible for providing clinical supplies of Ovaprene® and coordinating interactions with and preparing and submitting supportive regulatory documentation to the FDA. Daré and NICHD will each provide medical oversight for the trial and final data review and analysis, and will work together to prepare the final report of the trial results. Under the CRADA, Daré has also agreed to contribute $5.5 million toward the total estimated cost to conduct the pivotal Phase 3 study, which will be payable in four payments. The first payment is due within 30 days of the effective date of the CRADA and the final payment is due by April 1, 2023. NICHD will be responsible for the other costs related to the conduct of the pivotal study and will manage the payment of expenses to Health Decisions, the clin...