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 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. 

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 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. 

Explore Previously Funded Trials

Application and Review Process

A request for applications is launched each year, usually around December. Application materials then go through a rigorous, structured, and deliberative review process. The main steps in this process are: 

  • Researchers submit a short letter of intent, around 1–2 pages, describing the scope of the proposed trial, novelty of the idea, and how it aligns with the Association’s priorities. 
  • Association staff reviews letters of intent, selecting projects that align with the original request for applications. 
  • Selected researchers are invited to submit a full proposal, approximately 14 pages, that details the therapeutic 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 months after the initial launch. 

Learn More About Our Review Process

Grant Management 

Once a trial is approved for funding, designated 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. 

Grantees will be expected to adhere to the Association’s grant award terms and conditions. This includes: 

  • Establishing and maintaining effective internal controls to ensure the grant award will be used in compliance with the stated requirements. 
  • Agreeing to perform the project as proposed. 
  • Prudently managing the award and conducting the trial in accordance with its provisions. 
  • Seeking approval by the Association for any adjustment to grant-funded projects or aims prior to the change. 

More Information for Grant Applicants

Key Dates

  • LOI Deadline (CLOSED): January 25, 2024, 5 p.m. US ET 
  • Full Proposal Due (by invitation only): April 12, 2024, 5 p.m. US ET 
  • Anticipated Award Decision: June 2024 
  • Anticipated Earliest Start Date: July 2024 

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