This DOD grant supports ALS therapeutic development, from preclinical validation to FDA IND-enabling studies, requiring lead compounds and proof-of-concept data.
Dept. of the Army -- USAMRAA has archived this opportunity.
Funder: Dept. of the Army -- USAMRAA
Due Dates: June 6, 2025 (Pre-application) | August 27, 2025 (Full application, by invitation)
Funding Amounts: Up to $2,000,000 total costs per award over 3 years; approx. $10.5M available for ~5 awards.
Summary: Supports empirical, product-driven preclinical to IND-enabling ALS therapeutic development, requiring proof-of-concept and biomarker integration.
Key Information: Clinical trials are not permitted; lead compounds and preclinical efficacy data are required at application.
This award supports research focused on advancing therapeutic candidates for Amyotrophic Lateral Sclerosis (ALS) from preclinical validation through FDA Investigational New Drug (IND)-enabling studies. Projects must be empirical, product-driven, and begin with lead compounds that have already demonstrated proof-of-concept efficacy in at least one preclinical ALS model system. A critical component is the concurrent development of mechanism-specific, predictive, or pharmacodynamic biomarkers relevant to the therapeutic approach. Projects that only focus on biomarker development for diagnosis, prognosis, or general disease progression, or that propose candidates already granted an IND, are not eligible. Clinical trials are not allowed under this mechanism.