Pilot Clinical Trial Award – HT9425-23-ALSRP-PCTA
- up to USD$2M over 3 years
- Clinical Care Tier – up to USD$1M over 3 years
- Supports exploratory clinical trials of novel therapeutics to demonstrate feasibility and inform design of more advanced trials in ALS
- Must support a clinical trial and may not be used for preclinical research studies
- Biomarkers specific to the intervention must be incorporated into the trial design
- Preliminary data required
- must include at least on community partner
- Clinical Care Tier – for applications not investigating a novel therapeutic, but proposing a clinical trial to optimise established ALS clinical care (eg optimisation of respiratory care strategies; telemedicine strategies; improvements to approved devices)
Clinical Biomarker Development Award – HT9425-23-ALSRP-CBDA
- up to USD$750,000 over 2 years
- Supports development or improvement of clinical biomarkers to enrich clinical trials in ALS
- Biomarker analysis can be relevant to a specific therapeutic or a specific ALS subtype and does not have to broadly apply to all patients.
- A description of the biomarker category and intended use in ALS therapeutic development, including regulatory considerations for use in ALS clinical trials or clinical practice, is an important component.
Therapeutic Development Award – HT9425-23-ALSRP-TDA
- up to USD$1.5M over 3 years
- Supports secondary preclinical validation and Investigational New Drug (IND)-enabling studies of therapeutics for ALS.
- Preliminary data required, including therapeutic efficacy in at least one ALS-relevant model system.
- Mechanism-specific predictive/cohort-selective, target engagement, or pharmacodynamic biomarker development, in parallel to the main therapeutic effort, is a critical component.
Therapeutic Idea Award – HT9425-23-ALSRP-TIA
- up to USD$600,000 over 2 years
- Biomarker Option – up to USD$750,000 over 2 years
- Supports highly innovative, hypothesis-driven preclinical therapeutic development in ALS.
- Projects focusing primarily on investigating ALS pathophysiology, without consideration of therapeutic development, will not be funded
- Preliminary data not required.
- Early-Career Investigators are encouraged to apply.
- Biomarker Option: Applications that include development of biomarkers in parallel to the main therapeutic effort may qualify for a higher level of funding.
– pre-Applications due 13 April 2023 – https://cdmrp.health.mil/funding/alsrp
