Summary:
The fiscal year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) supports research ranging from preclinical validation of therapeutic leads through Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies.

The

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proposed studies are expected to be empirical in nature and product driven.

Applicants with limited Amyotrophic Lateral Sclerosis (ALS) experience are strongly encouraged to include collaborators with substantial experience in the relevant ALS model systems, endpoints, and pathophysiology.

Applications supported by this award must begin with lead compounds in hand and must already demonstrate proof-of-concept efficacy data in at least one appropriate preclinical model system of ALS, including whole animal and cellular model systems.

Distinctive Features:
Mechanism-specific, predictive/cohort-selective, target engagement, and pharmacodynamic biomarker development, in parallel to the main therapeutic effort, is a critical component of the FY25 ALSRP Therapeutic Development Award.

If appropriate mechanism-specific biomarkers are already available or currently in development, how the existing biomarkers will improve trial design, patient selection, and efficiency or interpretation of the proposed ALS therapeutic approach must be apparent in the application.

Development of biomarkers for the purposes of diagnosis, prognosis, or measurement of general disease progression without consideration of the therapeutic development process will not be supported.

Therapeutic candidates which have already been granted an IND are not appropriate for this mechanism