DARE - Daré Bioscience Announces Funding Award Notice from the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to Support DARE-PTB1 Phase 1 Human Clinical Study | Benzinga
DARE-PTB1 is being developed as a treatment to reduce the risk of preterm birth, for which there are no FDA-approved treatment options
Up to approximately $2 million in grant funding to support DARE-PTB1 Phase 1 human clinical study
SAN DIEGO, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that it received a Notice of Award of a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH). The award will support the clinical development of Daré's novel, investigational intravaginal ring (IVR), DARE-PTB1. DARE-PTB1 is designed to deliver bio-identical progesterone continuously for up to a 14-day period and is being developed as a treatment for the prevention of preterm birth in at-risk women, for which there are currently no FDA-approved treatments.
"The World Health Organization estimates that globally, 13.4 million babies were born preterm in 2020, before 37 weeks of gestation and that complications from preterm birth are the leading cause of death among children under 5 years of age1," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "Daré is committed to addressing persistent unmet needs in women's health and preterm birth is a large category that could benefit from new treatment options to protect women and babies. We are grateful to the NICHD for its support and commitment to innovation in this important therapeutic area and look forward to advancing DARE-PTB1, which has the potential to be the only FDA-approved product to reduce the risk of preterm birth."
Daré's IVR technology is designed to allow for sustained drug delivery over time periods ranging from weeks to months as a self-administered progesterone vaginal system.
In January 2023, Daré announced positive pharmacokinetic results from its Phase 1 / 2 clinical trial of DARE-HRT1, an investigational product which uses the same IVR technology as DARE-PTB1 to deliver non-oral, bio-identical progesterone and estradiol for the treatment of menopausal symptoms.
"The positive pharmacokinetic results from our DARE-HRT1 Phase 1 / 2 study validate the potential of Daré's IVR technology to continuously deliver hormone therapy over multiple consecutive weeks," said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. "We look forward to applying the learnings from that study to our DARE-PTB1 program and the work that the NICHD award will support."
Daré is eligible to receive up to a total of approximately $2 million in grant funding for its DARE-PTB1 program based on the grant application it submitted to support a DARE-PTB1 Phase 1 human clinical study. Approximately $1 million is available through 2024 and the award of the remaining approximately $1 million is subject to the availability of funds and satisfactory progress of the project, as determined by NICHD.
The content of this press release is solely the responsibility of Daré Bioscience, Inc. and does not necessarily represent the official views of the National Institutes of Health. This press release discusses a project that will be supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number 4R44HD101169-02.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and ...