DoD Amyotrophic Lateral Sclerosis, Therapeutic Development Award | W81XWH 18 ALSRP TDA

Opportunity Information: Apply for W81XWH 18 ALSRP TDA

The DoD Amyotrophic Lateral Sclerosis (ALS) Therapeutic Development Award is a Department of Defense funding opportunity designed to push promising ALS treatments closer to the clinic. It supports work that starts after an initial drug or biologic lead already exists and extends through advanced preclinical development, including the types of studies typically needed to justify filing an FDA Investigational New Drug (IND) application. The program is clearly aimed at practical, product-driven development rather than exploratory biology: proposed studies are expected to be empirical, focused on generating decision-quality data, and organized around advancing a specific therapeutic candidate toward human testing.

The kinds of projects this award supports sit in the middle-to-late stages of preclinical development. That includes confirming and strengthening candidate therapeutics that may have emerged from screening campaigns or earlier discovery efforts, optimizing potency and pharmacological properties, and testing related variants such as derivatives or sister compounds. It also includes validating early pilot findings by replicating preliminary results more rigorously, adding time points, expanding dose ranges, and testing across multiple ALS model systems (cellular and whole-animal), so that the evidence base is stronger and more reproducible. On the development side, the award can fund formulation and stability work that leads toward Good Manufacturing Practice (GMP) production methods, as well as IND-enabling packages such as compound characterization, ADME studies (absorption, distribution, metabolism, and excretion), and dose-response and toxicology studies in relevant models.

A notable feature of the opportunity is its encouragement of translational validation using human biospecimens, as long as those specimens already exist and are de-identified. Applicants are encouraged to use appropriately powered and well-controlled analyses with biological correlates of disease activity and progression, leveraging specimens from well-characterized patient cohorts such as controlled clinical trials, observational studies, or registries. The announcement specifically points to resources like the CDC National ALS Registry and Biorepository. A key restriction is that collecting new specimens is not allowed under this award; any specimens must be in hand by the time the application is submitted. The DoD also emphasizes considering active duty military and Veteran patient populations or related resources, aligning the program with military and public health relevance.

This award is not meant for very early discovery efforts, and it sets a relatively high bar for readiness. Applications must begin with lead compounds already in hand and must include preliminary data appropriate to the development stage being proposed. Examples of expected readiness evidence include proof of identity and purity, selectivity for the intended target relative to closely related targets, and established in vitro bioactivity assays (primary and secondary) that can support optimization and structure-activity relationship work. Applicants are also expected to have proof-of-concept efficacy data in relevant ALS preclinical models (both cellular and animal models) or, in some cases, informative clinical data from a related human disease that helps justify the therapeutic approach. For investigators who are still at the earlier, basic discovery stage and do not yet have that preliminary package, the notice points them toward a separate mechanism (the Therapeutic Idea Award) that is intended for drug discovery and does not require preliminary data.

For FY18, the program introduced an optional add-on called the Therapeutically Relevant Marker Option. This option provides an avenue for applicants to co-develop a marker alongside the therapeutic program, with additional funding available for marker work that directly improves drug development. The intent is not general biomarker discovery for its own sake; it is specifically focused on markers that make the therapeutic development pathway more efficient or more informative. Examples include pharmacodynamic biomarkers that objectively show whether the investigational therapy is having its intended biological effect, or predictive/cohort-selective biomarkers that help identify which patients (or subgroups) are more likely to respond. In contrast, marker development aimed only at diagnosis, prognosis, or measuring disease progression, without a direct tie to the therapeutic development process, is explicitly not supported. Applicants pursuing this option must submit a Therapeutically Relevant Marker Statement describing the marker and how it will enhance therapeutic development, and the announcement encourages alignment with FDA and ALS community guidance documents on ALS drug development.

Administratively, this opportunity was issued by the Department of Defense, Department of the Army (USAMRAA) under Funding Opportunity Number W81XWH-18-ALSRP-TDA. It was offered as a discretionary program using grant and cooperative agreement funding instruments under CFDA 12.420, with eligibility listed as unrestricted (open to many entity types, subject to any additional eligibility clarifications in the full announcement). The posting indicates an expected three awards, with an award ceiling listed as 0 in the extracted metadata (typically meaning applicants must refer to the full program announcement for exact budget limits and any option-related caps). The original posting date was April 10, 2018, with an original closing date of October 11, 2018. Above all, funded projects must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public, reinforcing the program’s mission to accelerate meaningful ALS therapeutics with real-world impact.

• 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 Apr 10, 2018.
• Applicants must submit their applications by Oct 11, 2018. (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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