U.S. CDMRP – Amyotrophic Lateral Sclerosis Research Program | Research Funding

Through the Congressionally Directed Medical Research Program (CDMRP), the Department of Defense is announcing the 2024 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Awards. Several award programs are available:

• The Clinical Outcomes and Biomarkers Award supports the development and/or validation of clinical outcomes and biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients. applications must address ONE or BOTH of the following focus areas listed here.
   
• The Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ALS. Projects may range from phase 1 to small-scale phase 2 trials and should aim to de-risk and inform the design of more advanced trials by investigating safety, feasibility, biomarker application, and therapeutic efficacy in relevant patient populations. Clinical trials may be designed to evaluate promising drugs, biologics, or devices with anticipated therapeutic impact that is supported by strong scientific rationale and existing preliminary studies and/or preclinical data. Clinical trials aimed to improve aspects of patient care and ALS symptom management are also applicable to this award mechanism. Pilot Clinical Trial Award must address one of the following Focus Areas: 1) Biomarker-Driven Interventions: Disease-modifying interventions, with mechanism specific predictive, efficacy, and/or pharmacodynamic biomarkers. 2) Clinical Care: Improving aspects of clinical care and symptom management for Amyotrophic Lateral Sclerosis (ALS).
   
• The Therapeutic Development Award supports research ranging from preclinical validation of therapeutic leads through Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited ALS experience are strongly encouraged to include collaborators with substantial experience in the relevant ALS model systems, endpoints, and pathophysiology.
   
• The Therapeutic Idea Award 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.

• Clinical Outcomes and Biomarkers Award: max. $750,000
• Pilot Clinical Trial Award: max. $2M
• Therapeutic Development Award: max. $1.5M
• Therapeutic Idea Award: max. $600,000

• Clinical Outcomes and Biomarkers Award: 3 years
• Pilot Clinical Trial Award: 4 years
• Therapeutic Development Award: 3 years
• Therapeutic Idea Award: 2 years

• 24 May 2024, 5:00 p.m. Eastern time

• 07 July 2024, 11:59 p.m Eastern Time

• To find the full program announcements and to start your pre-application see here
• A useful summary of each call can be found here
• For questions about the eBRAP or Grants.gov platforms, contact the Research Office.
• Grants.gov Funding Opportunity Numbers:
  • Clinical Outcomes and Biomarkers Award: HT942524ALSRPCOBA
  • Pilot Clinical Trial Award: HT942524ALSRPPCTA
  • Therapeutic Development Award : HT942524ALSRPTDA
• • Therapeutic Idea Award: HT942524ALSRPTIA