DOD Amyotrophic Lateral Sclerosis, Therapeutic Development Award | HT942524ALSRPTDA

Opportunity Information: Apply for HT942524ALSRPTDA

The FY24 DOD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (Funding Opportunity Number HT942524ALSRPTDA) is a discretionary federal grant opportunity run through the Department of the Army, USAMRAA, under CFDA 12.420. Its purpose is to move promising ALS therapeutics forward along a practical development path, supporting work that spans from preclinical validation of a therapeutic lead up through FDA Investigational New Drug (IND)-enabling studies. The program is explicitly product-driven and empirical, meaning it is designed to generate the kinds of data packages that can credibly support progression toward clinical testing rather than exploratory, hypothesis-only science.

A central requirement is that applicants must already have lead compounds in hand. In addition, the application must include proof-of-concept efficacy data in at least one preclinical ALS model system, which can include whole-animal models and cellular models. Because ALS models, endpoints, and disease biology can be technically demanding and easy to misapply, teams that do not have strong ALS-specific experience are strongly encouraged to bring in collaborators who have demonstrated expertise with relevant ALS model systems, outcome measures, and pathophysiology.

The award is intended to fund later-stage preclinical activities that strengthen confidence in a therapeutic candidate and prepare it for the regulatory steps that precede human trials. Supported efforts can include confirming candidate therapeutics identified through screening or other discovery approaches, along with medicinal chemistry and optimization work to improve potency and pharmacological properties, including testing derivative or closely related compounds. It can also support validation and expansion of early pilot efficacy findings, such as follow-on studies that replicate initial results more rigorously, add time points, test additional doses, and extend testing into additional ALS model systems. Beyond efficacy validation, the opportunity covers IND-enabling development tasks such as compound characterization and ADME work (absorption, distribution, metabolism, and excretion), formulation and stability studies, and the steps needed to reach Good Manufacturing Practice (GMP) production methods. It also anticipates dose-response characterization and toxicology studies in relevant model systems, reflecting the kind of integrated preclinical package typically needed to justify an IND submission.

A distinctive and emphasized feature of this award is the expectation that biomarker strategy is not optional or peripheral. The program states that mechanism-specific, predictive or cohort-selective biomarkers, target engagement measures, and pharmacodynamic biomarkers should be developed in parallel with the therapeutic work as a critical component of the project. If relevant biomarkers already exist or are being developed elsewhere, the application needs to clearly explain how those biomarkers will tangibly improve clinical trial design, patient selection, and the efficiency or interpretability of eventual trials for the proposed therapeutic approach. At the same time, the opportunity draws a firm boundary around what it will not support: biomarker work aimed only at diagnosis, prognosis, or tracking general disease progression, without a clear link to the therapeutic development plan, is considered out of scope for this mechanism.

The announcement also clarifies where earlier-stage or separate work should go. Applicants who are primarily pursuing basic ALS drug discovery and do not yet have preliminary efficacy data are directed instead to the FY24 ALSRP Therapeutic Idea Award (TIA), which does not require preliminary data. Likewise, applicants seeking biomarker development that is independent of a specific therapeutic development effort are encouraged to apply to the FY24 ALSRP Clinical Outcomes and Biomarkers Award (COBA), rather than trying to fit a standalone biomarker project into this Therapeutic Development Award.

Administratively, the opportunity lists eligibility as unrestricted and indicates an expected four awards. The original closing date is July 10, 2024, and the posting was created March 25, 2024. The award ceiling is not specified in the provided source data. Overall, the mechanism is best suited for teams that already have a credible ALS therapeutic lead with initial in-model efficacy, and that are ready to execute a tightly planned set of preclinical and IND-enabling studies, paired with a biomarker approach that directly supports patient stratification, target engagement confirmation, and decision-making for eventual clinical testing.

• 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 2024-03-25.
• Applicants must submit their applications by 2024-07-10. (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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