Hoffman ALS Clinical Trial Awards Program

Background

Clinical trials are the most reliable—and ultimately the fastest—way to translate promising laboratory science into new and better ways to treat and care for people living with ALS.

The Hoffman ALS Clinical Trial Awards Program helps develop new and improved ALS therapies by supporting early-stage clinical trials. These trials generally produce data on safety, dosing, and biomarkers that are essential for moving an investigational therapy one step closer to being evaluated by the FDA. Positive results at this stage also “de-risk” the next stage of drug development, typically large clinical trials, and help attract the follow-on funding necessary to complete this work.

Type and Scope of Funded Trials

These annual awards provide up to $1,000,000 over 2 to 3 years, allocated based on milestones, to support trials that:

• Are in the early to mid-phase of clinical testing (phase 1 or phase 2a).
• Include people living with genetic or sporadic forms of ALS, healthy subjects, and/or asymptomatic carriers of ALS-linked genetic mutations.
• Are testing novel or repurposed approaches for ALS (either disease-modifying or symptomatic), including small molecules, genetic therapies, stem cell approaches, peptides, antibodies, and antisense therapies.

Eligibility

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• Individuals with the skills, knowledge, and resources necessary to carry out the proposed research may apply as a principal investigator (PI).
• U.S. and non-U.S. public and private non-profit entities, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government.
• U.S. and non-U.S. biotechnology / pharmaceutical companies or other publicly or privately held for-profit entities.
• The applicant organization must be the organization that controls the intellectual property under development, except in situations where a generic medication is being repurposed for ALS. Please consult with Association staff if you need clarification.

Ineligibility

• Postdoctoral fellows are not eligible to apply as a PI.
• The following are not appropriate for this funding opportunity, and applications focusing on these topics will be administratively withdrawn:
  • Non-pharmacological interventions
  • Surgical interventions
  • Observational studies
  • Natural history studies