Beta Amyloid Peptide: Grant: Preclinical Development of Novel Therapeutics Targeting Aging Mechanisms (SBIR U44 Clinical Trial Not Allowed)

This Funding Opportunity Announcement (FOA) utilizes the SBIR cooperative agreement (U44) activity code to support the preclinical development of emerging therapeutics targeting fundamental mechanisms of aging (e.g., inflammation, cell senescence, proteostasis). This includes the translation of a broad range of potential geroscience-based therapies, such as new classes of compounds (e.g., senolytics), biologics, stem/progenitor cell-based therapies, repositioning of existing investigational drugs, and repurposing of Food and Drug Administration (FDA)-approved drugs for the treatment and prevention of clinical conditions related to aging and common in the aged. Examples of translational research activities eligible under this FOA include target validation, optimization of lead compounds, pharmacokinetics and drug disposition studies, and preclinical safety/toxicology studies. NIA encourages the submission of applications which involve translational research activities across all stages of preclinical drug development. The development and validation of new methodologies (e.g., organoids, in silico approaches) necessary to advance preclinical development of a given therapeutic are also allowed. While the use of relevant human in vitro systems (e.g., organoids, microphysiological systems (MPS), induced pluripotent stem cells (PSCs)) is strongly encouraged in the preclinical development process, the conduct of first-in-human (FIH) studies and/or early phase clinical trials are outside the scope of this FOA.

Applicants must include a Target Product Profile (TPP) based on FDA guidance in their applications. In addition, U44 awardees will be required to convene periodic meetings with the FDA to discuss any necessary modifications to the TPP based on research progress or to meet specific regulatory requirements (e.g., pre-IND meeting).

Preclinical development of new drugs for Alzheimer's disease and its related dementias (AD/ADRD) are outside the scope of this FOA, as several other NIA FOAs are available for this purpose. Information on current NIA FOAs on AD/ADRD is available at https://www.nia.nih.gov/ad-foas.