DOD Amyotrophic Lateral Sclerosis, Therapeutic Development Award | HT942525ALSRPTDA

Opportunity Information: Apply for HT942525ALSRPTDA

The FY25 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) is a Department of Defense grant program aimed at moving promising ALS treatments from the later stages of preclinical development toward readiness for human testing. It is designed to fund research that is clearly product-driven and focused on generating the practical data packages typically needed to advance a therapeutic candidate, covering work from preclinical validation of therapeutic leads through FDA Investigational New Drug (IND)-enabling studies. In other words, this opportunity is meant for teams that already have a therapeutic lead they want to push toward the clinic, not for early discovery or basic exploratory projects.

A key eligibility and readiness expectation is that applicants must start with lead compounds already in hand and must be able to show proof-of-concept efficacy in at least one appropriate ALS preclinical model system. The program explicitly recognizes both whole-animal and cellular ALS models as relevant, but the expectation is that the application is grounded in empirical evidence rather than purely hypothetical rationale. For groups that are newer to ALS, the program strongly encourages adding collaborators who have deep experience with ALS-specific model systems, endpoints, and disease biology, which signals that reviewers will be looking closely at whether the team can execute ALS-relevant studies in a way that is credible and interpretable for eventual translation.

One of the most distinctive requirements of this award is its emphasis on biomarkers that directly support therapeutic development. Applicants are expected to incorporate, alongside the main drug development plan, biomarker efforts that are mechanism-specific and useful for decision-making in clinical translation. The notice highlights several preferred biomarker categories: predictive or cohort-selective biomarkers (to help identify which patients are most likely to respond or to define trial subgroups), target engagement biomarkers (to demonstrate that the drug is hitting its intended target in a biological system), and pharmacodynamic biomarkers (to show the downstream biological effect of the therapy). The program also makes clear that biomarker plans should be tied to practical improvements in trial design, patient selection, and the efficiency or interpretability of clinical studies. If such biomarkers already exist or are already being developed elsewhere, the application should clearly explain how those existing tools will be used to strengthen the therapeutic development pathway rather than proposing biomarker work as a parallel, disconnected activity.

At the same time, the program draws a firm boundary around what it will not support in the biomarker space. Biomarker development that is primarily for diagnosis, prognosis, or general tracking of disease progression is not responsive unless it is explicitly integrated into and justified by the needs of the therapeutic development process. This is essentially a signal that the biomarker component must be actionable for advancing a specific candidate, such as enabling better dose selection, confirming mechanism engagement, or enriching a trial population, rather than building general ALS biomarker knowledge.

The award is also positioned before the IND stage, and that matters for fit. Therapeutic candidates that already have an FDA IND are stated to be inappropriate for this funding mechanism, indicating that the program is targeting the gap between strong preclinical proof-of-concept and the formal regulatory milestone of IND clearance. Applicants therefore need to be in the stage where IND-enabling studies are still ahead, and the proposed work should logically build toward the IND package.

Administratively, this opportunity is a discretionary grant issued by the Department of the Army through USAMRAA, listed under Funding Opportunity Number HT942525ALSRPTDA and CFDA 12.420 (Science and Technology and other Research and Development). Eligibility is listed as unrestricted, suggesting a broad applicant pool. The original closing date is August 27, 2025, and the program anticipates making about four awards. The notice lists an award ceiling field but does not provide a number in the text provided, so applicants would need to consult the full announcement for the maximum budget and any period-of-performance limits.

Overall, the best fit for this award is a team with a defined ALS therapeutic candidate, existing in vivo and/or in vitro proof-of-concept efficacy data, and a concrete plan to complete the kinds of pharmacology, safety, and translational studies that move a therapy toward an IND. Competitive applications will likely be those that treat biomarker development as an integral part of de-risking the therapy and shaping smarter clinical trials, rather than as a standalone biomarker research project.

• The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Amyotrophic Lateral Sclerosis, Therapeutic Development Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on 2025-04-18.
• Applicants must submit their applications by 2025-08-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 4 candidate(s).
• Eligible applicants include: Unrestricted.

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