DoW Amyotrophic Lateral Sclerosis Research Program, Therapeutic Development Award
This grant funds research to develop and validate new ALS therapies, requiring proof-of-concept data and a focus on integrating mechanism-specific biomarkers to support FDA IND-enabling studies.
Funder: Dept. of the Army -- USAMRAA
Due Dates: June 24, 2026: Pre-Application (Preproposal) | September 30, 2026: Full Application | October 6, 2026: End of Application Verification Period
Funding Amounts: Estimated total program funding: $12,000,000; up to ~$2,000,000 total costs per award over 3 years; ~6 awards expected.
Summary: Supports preclinical and IND-enabling research for ALS therapeutics, requiring proof-of-concept efficacy and integration of mechanism-specific biomarker development.
Key Information: IND-approved candidates are not eligible; clinical trials are not supported; lead compound and efficacy data required at application.
Description
This opportunity funds research projects focused on the development of therapeutics for amyotrophic lateral sclerosis (ALS), spanning from preclinical validation of therapeutic leads through FDA Investigational New Drug (IND)-enabling studies. Projects must be empirical and product-driven, and must begin with lead compounds in hand, accompanied by proof-of-concept efficacy data in at least one relevant preclinical ALS model (whole-animal or cellular). A key feature of this award is the integration of mechanism-specific, predictive/cohort-selective, target engagement, and pharmacodynamic biomarker development that directly supports the therapeutic development process. Biomarker development solely for diagnosis, prognosis, or general disease progression—without direct relevance to therapeutic development—will not be supported.
Therapeutic candidates that have already been granted an IND are not eligible for this mechanism. Clinical trials are not supported, but validation studies using preexisting, de-identified human specimens are permitted. The program encourages multidisciplinary collaborations, including those with experience in ALS model systems and biomarker development.
