DoD Amyotrophic Lateral Sclerosis Research, Therapeutic Development Award | W81XWH 19 ALSRP TDA

Opportunity Information: Apply for W81XWH 19 ALSRP TDA

The DoD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award is designed to push promising ALS treatments forward along the development pipeline, starting at the point where a team already has a credible therapeutic lead and moving through key preclinical milestones that support an FDA Investigational New Drug (IND) application. The focus is not exploratory biology or early discovery, but practical, empirical, product-driven work that reduces risk and increases readiness for clinical testing. Projects are expected to look and feel like real translational development programs, with clear go/no-go data, fit-for-purpose assays, and a path toward regulated development rather than open-ended hypothesis generation.

The kinds of activities this award supports span several common late-preclinical steps. It can fund confirmation and strengthening of candidate therapeutics that came out of prior screening or other selection approaches, including optimization work to improve potency, selectivity, and drug-like properties, and testing closely related derivatives or sister compounds to support structure-activity relationship decisions. It can also support expansion of early pilot findings into more convincing preclinical packages, such as replicating preliminary results with more time points, additional doses, and the use of multiple ALS model systems (both cellular and whole-animal where appropriate). On the chemistry and manufacturing side, the award can cover formulation and stability work that enables Good Manufacturing Practice (GMP)-compatible production methods, which is often required before moving a compound into human trials. It also explicitly supports IND-enabling studies, including compound characterization and ADME work (absorption, distribution, metabolism, and excretion), as well as dose-response and toxicology studies conducted in relevant model systems, with the overall intent of generating the data package regulators expect before first-in-human studies.

A notable feature is the encouragement to use biological correlates of disease activity or progression in pre-existing, de-identified human specimens drawn from well-characterized cohorts. Acceptable sources include controlled clinical trials, observational studies, and registries such as the CDC National ALS Registry and associated biorepository. The intent here is to anchor development decisions in human-relevant biology when possible, strengthening translational credibility. The opportunity also signals an interest in military relevance by encouraging applicants to consider active duty Service member and/or Veteran patient populations or resources. At the same time, it draws a clear boundary: the collection of new human specimens is not supported. Any specimens proposed for use must already exist at the time the application is submitted, which means applicants need to have access arrangements and feasibility lined up early.

This award is not meant for teams that are still ideating or fishing for a lead. Applications must begin with lead compounds already in hand, and they must include preliminary data matched to the proposed stage of development. The solicitation lists examples of expected readiness indicators, including proof of identity and purity for the therapeutic, evidence of selectivity for the intended target over closely related targets, and the availability of primary and secondary in vitro bioactivity assays that can support optimization or structure-activity relationship work. It also expects proof-of-concept efficacy data in appropriate preclinical ALS model systems (cellular and/or whole-animal), or alternatively informative clinical data from a related human disease that meaningfully supports the therapeutic rationale. For investigators who are earlier in the pipeline and focused on basic drug discovery without preliminary data, the program points them instead to the separate Therapeutic Idea Award mechanism.

Because ALS is complex and model-dependent, the opportunity emphasizes the value of domain expertise. Applicants who have limited ALS experience are strongly encouraged to collaborate with researchers who have substantial ALS expertise and/or deep familiarity with ALS model systems. In practice, this means applications are expected to demonstrate not just a promising molecule or approach, but also a credible team and experimental plan that can generate development-grade evidence in accepted models, using appropriate controls, powering, and study design rigor.

The solicitation also offers an optional add-on track called the Therapeutically Relevant Marker Option. This option provides additional funding for teams that will develop a specific biomarker or marker in parallel with the therapeutic development program, but only if that marker directly improves the drug development process. Examples include pharmacodynamic biomarkers that objectively measure whether the investigational therapy is having its intended biological effect, or predictive/cohort-selective biomarkers that help identify which patients (or subgroups) are most likely to respond. The program is explicit about what does not qualify: marker development aimed solely at diagnosis, prognosis, or general measurement of disease progression is not supported unless it is clearly tied to enabling the therapy and accelerating or de-risking development decisions. To pursue this option, applicants must submit a Therapeutically Relevant Marker Statement describing the marker and why it will improve the therapeutic development pathway. Applicants are also encouraged to consult FDA ALS drug development guidance and a patient-focused ALS community guidance document to align marker and development plans with current expectations and consensus priorities.

From an administrative and funding standpoint, this FY19 opportunity was offered by the Department of Defense, Department of the Army, through USAMRAA under Funding Opportunity Number W81XWH-19-ALSRP-TDA. The funding instrument type includes grants and cooperative agreements, and eligibility is described as unrestricted (open to any entity type, subject to any additional clarifications in the full announcement). The program anticipated making about three awards. For budgeting, the anticipated direct costs over the entire period of performance were capped at $1,000,000 for standard Therapeutic Development Awards, and up to $1,250,000 for applications that include the Therapeutically Relevant Marker Option. The opportunity was originally posted in late 2018 and had a closing date in July 2019, reflecting the FY19 cycle referenced throughout the description.

• 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 Research, 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 Nov 20, 2018.
• Applicants must submit their applications by Jul 25, 2019. (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 3 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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