The Hoffman ALS Clinical Trial Awards Program

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 “de-risk” the next stage of drug development, typically large clinical trials, and help attract the follow-on funding necessary to complete this work. The Hoffman ALS Clinical Trial Awards Program also supports early trials of imaging tracers in people living with ALS.

The application period for 2025 has closed. Click here to explore other funding opportunities.

Research Vial that says "For Clinical Trial Use Only"

Type and Scope of Funded Trials

These annual awards provide up to $1,000,000 over 2 or 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.

Early trials testing imaging tracers in people living with ALS are also considered to be in scope for this funding opportunity.

Explore Previously Funded Trials

Application and Review Process

The application process has two phases—a letter of intent followed by a full proposal (submitted by invitation only). The main steps in this process are: 

Researchers submit a short letter of intent, approximately three to four pages, describing the target biology, therapeutic/tracer under investigation, trial design, biomarker strategy, and development and commercialization plan. 
Association staff reviews letters of intent, selecting projects that align with the intent of The Hoffman ALS Clinical Trial Awards Program and the mission of the ALS Association. 
Selected researchers are invited to submit a full proposal, approximately 14 pages, that describes in greater detail the therapeutic/tracer under investigation, scientific plan, research team, business plan, and budget. 
Full proposals are peer-reviewed, critiqued, and scored by a Scientific Review Committee made up of independent external experts. 
Selected proposals are submitted to the Research Committee of the Association’s Board of Trustees for review, discussion, and final approval, including funding amount. 
Award decisions are typically made approximately 6 to 8 months after the initial launch.

Learn More About Our Review Process

Grant Management

Once a trial is approved for funding, Association staff will:

Notify the selected researcher.
Develop, negotiate, and issue a contract that outlines milestones, expectations, and approved uses for the grant.
Monitor progress and issue grant payments once milestones are reached.

All grantees are expected to adhere to the Association’s grant award terms and conditions, which are outlined in the Grant Policy Statement. 

More Information for Grant Applicants

Key Dates

Letter of Intent Deadline: November 26, 2024, 1:00 p.m. US ET
Full Proposal Deadline (by invitation only): February 25, 2025, 1:00 p.m. US ET
Anticipated Award Decision: May 2025
Anticipated Earliest Start Date: July 1, 2025