Therapeutic targeting of FKBP51 for the prevention of stress-induced preterm birth
Active Project Grant Awarded Last action
- Award ID
- R44HD113465
- Recipient
-
Dare Bioscience, Inc. UEI UC4EFLZHANH4
- Awarding agency
-
National Institute of Child Health and Human Development
National Institutes of Health, Department of Health and Human Services
- Obligated
- $907,702
Award facts
- Assistance listing
- 93.865 Child Health and Human Development Extramural Research
- Completion date 64% complete
- Place of performance
- San Diego, CA 92122, USA
Award details come from USAspending.gov.
Description
- Abstract
- In the united states, one in ten babies is born prematurely, often leading to extended hospital stays and serious health issues such as respiratory distress syndrome, necrotizing enterocolitis, deafness, vision problems, and cerebral palsy. Maternal and fetal stress are known risk factors for preterm birth, with recent mouse model studies highlighting the role of the stress response protein FKBP51 in this process. Stress increases levels of FKBP51, which then binds to progesterone receptors in decidual cells, inhibiting their activity, thereby triggering the functional withdrawal of progesterone that leads to preterm labor. This pathway can be blocked by 15-deoxy- Δ12,14-prostaglandin J2 (15DPGJ2), which restores progesterone receptor activity by reducing stress-induced FKBP51 levels and FKBP51-PR interaction. Targeting FKBP51 offers a promising strategy for preventing preterm birth, an area with no existing pharmacological options. In successful phase I studies, daré bioscience, in collaboration with the university of south florida, validated uterine FKBP51 as a drug target for the prevention of stress induced preterm birth and further demonstrated the feasibility of blocking FKBP51 with 15DPGJ2 using human cells and mouse models. Phase II work aims to formulate 15DPGJ2 with progesterone as a mini-tablet vaginal insert and optimize the treatment regimen in the mouse. The optimized treatment will then be evaluated in standard preclinical studies focusing on pharmacokinetics, safety, and toxicity. Data collected during phase II will facilitate a successful pre-IND meeting with the FDA. Our goal is to develop a safe and effective therapy to prevent preterm birth, with broad implications for improving neonatal and maternal health outcomes.
Quick answers
Who received award R44HD113465?
R44HD113465 was awarded to Dare Bioscience, Inc. by National Institute of Child Health and Human Development (National Institutes of Health) on August 1, 2023.
How much is award R44HD113465 worth?
$907,702 has been obligated on R44HD113465.
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