DoD Amyotrophic Lateral Sclerosis Therapeutic Development Award | W81XWH 20 ALSRP TDA

Opportunity Information: Apply for W81XWH 20 ALSRP TDA

The DoD Amyotrophic Lateral Sclerosis (ALS) Therapeutic Development Award (FY20 ALSRP TDA; Funding Opportunity Number W81XWH 20 ALSRP TDA) is designed to push promising ALS treatment candidates forward along the drug development pipeline, starting at the point where a team already has a credible therapeutic lead in hand. The program specifically targets work from therapeutic lead validation through FDA Investigational New Drug (IND)-enabling studies. In practice, that means the Department of Defense is looking for research that is empirical, product-driven, and focused on producing the data package needed to responsibly move a therapy toward first-in-human testing later on (even though clinical trials themselves are not allowed under this award).

A central theme of this opportunity is readiness: applicants are expected to begin with lead compounds or a lead class of compounds already identified, and they must bring solid preliminary data that match the stage of development they are proposing. At a minimum, the program requires evidence of efficacy in at least one ALS-relevant model system (which can include cellular and whole-animal models). Beyond efficacy, applicants are expected to demonstrate practical drug development fundamentals such as proof of compound identity and purity, evidence of selectivity for the intended target (especially versus closely related targets), and the existence of workable in vitro assays (primary and secondary) that can support optimization efforts and structure-activity relationship studies. The overall expectation is that proposals are not early discovery projects; they are development-oriented efforts aimed at de-risking a specific therapeutic candidate.

The award supports a range of preclinical development activities that commonly sit between initial discovery and IND submission. Examples include confirming and strengthening candidate therapeutics that came out of screening or other discovery approaches, optimizing potency and drug-like properties, and evaluating derivatives or related compounds to improve performance. It also supports moving beyond small pilot findings by replicating results with stronger study designs, such as incorporating multiple ALS model systems, adding time points, or testing additional doses to better define dose-response relationships. On the more translational side, the program allows formulation and stability studies that can lead into Good Manufacturing Practice (GMP) production methods, as well as classic IND-enabling work such as compound characterization, ADME (absorption, distribution, metabolism, and excretion) studies, and appropriately designed dose-response and toxicology studies in relevant model systems.

Clinical trials are explicitly not permitted, but the program does encourage a specific type of human-data validation that can strengthen a translational case: testing biological correlates of disease activity or progression using pre-existing, de-identified human specimens from well-characterized patient cohorts. In other words, teams can use already collected biospecimens or datasets to validate aspects of a treatment approach, as long as those materials already exist at the time the application is submitted. The solicitation points to acceptable sources such as specimens or datasets from controlled clinical trials, observational studies, publicly available biorepositories, and registries, including resources like the CDC National ALS Registry and Biorepository. If applicants plan to use a different repository, they are expected to provide a letter of support that explains key details about the resource and how data and samples are broadly accessible. The opportunity also signals that active duty military and Veteran patient populations and related resources should be considered where relevant. Importantly, collecting new human specimens is not supported under this mechanism, so any human-sample component must rely on existing materials.

A defining requirement of the Therapeutic Development Award is its emphasis on biomarkers that are directly useful for therapeutic development and eventual clinical trials. The DoD makes it clear that having validated biomarkers available, or conducting biomarker development and characterization in parallel with the therapeutic work, is not optional but a critical component. The program is interested in biomarkers that help answer practical drug development questions, such as whether the drug hits its target (target engagement biomarkers), whether it produces a measurable biological effect consistent with the proposed mechanism (pharmacodynamic biomarkers), and whether certain patients or subgroups are more likely to respond (predictive or cohort-selective biomarkers). Biomarker work that is purely aimed at diagnosis, prognosis, or tracking disease progression without a clear tie to accelerating or strengthening the therapeutic development pathway is not considered responsive. Applicants are expected to clearly define the biomarker, explain how it will be used, and justify how it improves the efficiency and interpretability of the overall therapeutic development plan.

Because ALS is a complex disease and model systems and endpoints can be technically demanding, the opportunity strongly encourages teams with limited ALS experience to partner with collaborators who have deep expertise in ALS pathophysiology, relevant model systems, and appropriate outcome measures. This reflects the program’s practical orientation: proposals are expected to generate decisive, development-quality evidence, so the DoD wants applicants to build teams capable of executing rigorous ALS-relevant studies that will stand up to later regulatory and clinical scrutiny.

Administratively, this is a discretionary Department of Defense funding opportunity administered by the U.S. Army Medical Research Acquisition Activity (USAMRAA), using grant and cooperative agreement mechanisms under CFDA 12.420. Eligibility is described as unrestricted (open to any entity type, subject to any additional eligibility clarifications in the full announcement). The opportunity was originally released January 17, 2020, with an original closing date of July 23, 2020, and it anticipated a small number of awards (two expected). The listing shows an award ceiling of 0, which typically indicates that applicants need to consult the full announcement for budget parameters or that a specific cap was not captured in the summarized field.

Overall, the FY20 ALSRP Therapeutic Development Award is best understood as a bridge from promising preclinical ALS therapeutic leads to an IND-ready package, with a strong preference for projects that already have credible efficacy signals, a clear optimization and IND-enabling plan, and a biomarker strategy tightly linked to decision-making and eventual clinical translation. It also encourages thoughtful use of existing human biospecimens and datasets to reinforce translational relevance, while keeping the program’s scope firmly on preclinical and IND-enabling development rather than clinical testing.

• 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 Jan 17, 2020.
• Applicants must submit their applications by Jul 23, 2020. (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 2 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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