The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads to Phase I clinical trials and readiness for the Early Phase Pain Investigation Clinical Network (EPPIC-Net) https://heal.nih.gov/research/clinical-research/eppic-net or other Phase II clinical studies. Applicants must have a promising biologic or small molecule hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, development of a pharmacodynamic/target engagement biomarker, assembly and filing of an Investigational New Drug (IND) application and Phase I clinical testing. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.
Deadlines:
- Letter of Intent Due Date(s): 30 days prior to receipt date.
- Application Due Date(s): November 18, 2020, March 24, 2021, July 14, 2021, October 15, 2021, February 15, 2022, June 15, 2022, October 14, 2022, February 14, 2023, June 15, 2023, October 17, 2023
- AIDS Application Due Date(s): Jan. 7, May 7, Sep. 7
RFA-NS-21-010 Expiration Date New Date January 8, 2024 (Original Date: May 8, 2023) per issuance of NOT-NS-22-077