The DOD is offering the Amyotrophic Lateral Sclerosis Therapeutic Idea Award to foster innovative drug and therapy discovery for ALS.

The FY24 ALSRP Therapeutic Idea Award (TIA) supports new, innovative, high-risk, high-gain ideas aimed at Amyotrophic Lateral Sclerosis (ALS) drug or therapy discovery. The studies supported by this award mechanism are expected to be hypothesis-driven and generate preliminary data for future avenues of therapeutic investigation. Projects that focus primarily on pathophysiology of ALS without development of a therapy are outside the scope of this funding opportunity.

Applications may demonstrate the ability to achieve interpretable results in the absence of preliminary data supporting the hypothesis. While the inclusion of preliminary data is not prohibited, the strength of the application should rely on the approach.

The key elements of this award mechanism are:

• Innovation: Research deemed innovative may introduce a new paradigm, challenge current paradigms, introduce novel concepts or technologies, or exhibit other uniquely creative qualities that may lead to potential therapeutics for ALS.

• Impact: The FY24 TIA can be for a specific ALS subtype and does not have to broadly apply to all patients. Research should be non-incremental and pioneer transformative results that could lay the foundation for a new direction in the field of ALS therapy development. Incremental research does not meet the intent of this funding opportunity.

• Strong Scientific Rationale: Projects that address in the intent of the mechanism should include a well-formulated, testable hypothesis based on strong scientific rationale that holds translational potential to improve ALS treatment and/or advance a novel treatment modality.

• Biomarkers: Applicants are required to include consideration to biomarker(s) development in parallel with their proposed Therapeutic Idea Award research for eventual clinical trials. Efforts should be mechanism-specific and may include development of target engagement biomarkers, objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup, including pre-symptomatic gene carriers. Development of markers for the purposes of diagnosis, prognosis, or measurement of disease progression apart from consideration of the therapeutic development process will not be supported and instead investigators should consider the Clinical Outcomes and Biomarkers Award (HT942524ALSRPCOBA).

The FY24 ALSRP Therapeutic Idea Award (TIA) supports new, innovative, high-risk, high-gain ideas aimed at Amyotrophic Lateral Sclerosis (ALS) drug or therapy discovery. The studies supported by this award mechanism are expected to be hypothesis-driven and generate preliminary data for future avenues of therapeutic investigation. Projects that focus primarily on pathophysiology of ALS without development of a therapy are outside the scope of this funding opportunity.

Applications may demonstrate the ability to achieve interpretable results in the absence of preliminary data supporting the hypothesis. While the inclusion of preliminary data is not prohibited, the strength of the application should rely on the approach.

The key elements of this award mechanism are:

• Innovation: Research deemed innovative may introduce a new paradigm, challenge current paradigms, introduce novel concepts or technologies, or exhibit other uniquely creative qualities that may lead to potential therapeutics for ALS.

• Impact: The FY24 TIA can be for a specific ALS subtype and does not have to broadly apply to all patients. Research should be non-incremental and pioneer transformative results that could lay the foundation for a new direction in the field of ALS therapy development. Incremental research does not meet the intent of this funding opportunity.

• Strong Scientific Rationale: Projects that address in the intent of the mechanism should include a well-formulated, testable hypothesis based on strong scientific rationale that holds translational potential to improve ALS treatment and/or advance a novel treatment modality.

• Biomarkers: Applicants are required to include consideration to biomarker(s) development in parallel with their proposed Therapeutic Idea Award research for eventual clinical trials. Efforts should be mechanism-specific and may include development of target engagement biomarkers, objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup, including pre-symptomatic gene carriers. Development of markers for the purposes of diagnosis, prognosis, or measurement of disease progression apart from consideration of the therapeutic development process will not be supported and instead investigators should consider the Clinical Outcomes and Biomarkers Award (HT942524ALSRPCOBA).