DOD Amyotrophic Lateral Sclerosis, Therapeutic Development Award | HT9425 23 ALSRP TDA

Opportunity Information: Apply for HT9425 23 ALSRP TDA

The Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (FY23) is designed to push promising ALS drug candidates from the later stages of preclinical development toward readiness for human testing. The central focus is on practical, data-driven work that advances a specific therapeutic product, rather than exploratory or purely mechanistic research. Projects supported under this award are expected to be empirical and milestone-oriented, spanning activities from validating preclinical therapeutic leads through the types of studies generally needed to support a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application.

This opportunity is aimed at teams that already have a serious starting point: applicants must begin with lead compounds in hand and include preliminary data that match the proposed development stage. In practice, that means the application should show evidence such as verified identity and purity of the compound, selectivity for the intended target compared with closely related targets, and the existence of workable in vitro assays (both primary and secondary) that can be used for optimization and structure-activity relationship efforts. Critically, the program expects clear efficacy data in at least one relevant preclinical ALS model, supported by appropriate study power and sound methodology, since the award is meant to fund the next steps of development rather than the earliest discovery phase.

The award supports several categories of translational work that commonly sit between early discovery and clinical trials. One example is confirmation and refinement of candidate therapeutics that were identified through screening or other discovery approaches, including improving potency, optimizing pharmacological properties, and testing related derivatives or sister compounds. Another major use is to strengthen and validate early efficacy signals, such as expanding beyond pilot studies (including those generated through an ALSRP Therapeutic Idea Award) by reproducing preliminary findings, adding time points, exploring additional dosing regimens, and testing in additional ALS model systems to improve confidence that the effect is real and robust.

A significant portion of the supported work may also fall under IND-enabling studies, which are the development activities typically required before approaching the FDA to initiate clinical testing. These can include compound characterization and ADME studies (absorption, distribution, metabolism, and excretion), formulation and stability work that helps define how a drug can be manufactured and delivered, and steps leading toward Good Manufacturing Practice (GMP) production methods. The program also anticipates dose-response studies and toxicology evaluations in relevant model systems, since safety and dosing justification are key components of an IND package.

Because ALS drug development is highly dependent on disease-specific models, endpoints, and biological context, the program explicitly encourages applicants who have limited ALS experience to partner with collaborators who have deep expertise in ALS pathophysiology and established model systems. This emphasis is meant to increase the likelihood that studies use appropriate outcome measures, interpret results correctly, and generate data that can credibly support later regulatory and clinical steps.

From an administrative standpoint, the funding opportunity is offered by the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under Funding Opportunity Number HT9425-23-ALSRP-TDA, within CFDA 12.420. The opportunity was categorized as discretionary and allows for funding through a grant or a cooperative agreement. Eligibility is described as unrestricted (open to any type of entity, subject to any additional eligibility details in the full announcement). The posting indicates an expected four awards, with an original application deadline of July 13, 2023, and a creation date of February 8, 2023. The listing shows an award ceiling of 0, which typically signals that the ceiling may be defined elsewhere in the full program announcement or may vary based on project scope rather than being capped at a single fixed amount in the summary record.

Finally, the Therapeutic Development Award is not intended for basic ALS drug discovery projects that lack preliminary validation. Applicants who are earlier in the pipeline, especially those pursuing foundational discovery without prior efficacy data, are directed instead to the ALSRP Therapeutic Idea Award (HT9425-23-ALSRP-TIA), which is positioned for earlier-stage concepts and does not require preliminary data.

• The Department of Defense, 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 Feb 08, 2023.
• Applicants must submit their applications by Jul 13, 2023. (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 (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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