[ALS Association](https://www.als.org)

November 2025 (Letter of Intent) | February 2026 (Full Proposal, by invitation)

Up to $1,000,000 total over 2 or 3 years, milestone-based.

Supports early-stage clinical trials to accelerate new ALS therapies and improve patient care.

Application is a two-step process (LOI, then full proposal by invitation); open to both academic and industry investigators.

--- ## Description The program funds early to mid-phase (phase 1 or 2a) clinical trials for new or repurposed ALS therapies, including both disease-modifying and symptomatic treatments. The goal is to generate essential safety, dosing, and biomarker data to advance investigational therapies toward FDA evaluation and attract subsequent funding. Early trials of imaging tracers in ALS are also eligible. The program is designed to de-risk further drug development and speed the translation of promising science into improved treatments and care for people living with ALS. --- ## Due Dates - **Letter of Intent Deadline (anticipated):** November 2025 - **Full Proposal Deadline (by invitation only, anticipated):** February 2026 - **Anticipated Award Decision:** May 2026 - **Anticipated Earliest Start Date:** July 2026 *All dates are projected based on the annual cycle; check the program page for updates.* --- ## Funding Amount - Up to **$1,000,000** in total costs per award, distributed over 2 or 3 years. - Funding is milestone-driven and contingent on progress. - Indirect costs are capped at 10% of total direct costs. --- ## Eligibility - Open to both academic and industry investigators. - Applicants must have the skills, knowledge, and resources to carry out the proposed research. - Postdoctoral fellows are **not eligible** to apply as principal investigators. - Projects must be early to mid-phase interventional clinical trials (phase 1 or 2a). - Eligible trial populations: individuals with genetic or sporadic ALS, healthy subjects, or asymptomatic carriers of ALS-linked mutations. - Supported therapeutic approaches: small molecules, genetic therapies, stem cell approaches, peptides, antibodies, antisense oligonucleotides, and imaging tracers. - IND (or equivalent) approval is required, with the application submitted no later than 3 months after the project start date. - Non-pharmacological, surgical, observational, or natural history studies are not eligible. --- ## Application Process - **Step 1: Letter of Intent (LOI)** - Submit a 3–4 page LOI outlining the target biology, therapeutic/tracer, trial design, biomarker strategy, and development/commercialization plan. - LOIs are reviewed for alignment with the program mission; only selected applicants are invited to submit a full proposal. - **Step 2: Full Proposal (by invitation only)** - Invited applicants submit a detailed proposal (~14 pages) covering the scientific plan, research team, business plan, and budget. - Full proposals undergo external peer review by a Scientific Review Committee. - **Review and Award** - Applications are reviewed for scientific merit, feasibility, and impact. - Final funding decisions are made by the Research Committee of the ALS Association’s Board of Trustees. - Awardees enter into a contract specifying milestones and reporting requirements. - **Submission Platform** - All materials must be submitted electronically via [ProposalCentral](https://proposalcentral.com/). --- ## Additional Information - Awardees must adhere to the [ALS Association Grants Policy Statement](http://www.als.org/Grants-Policy-Statement). - Progress reports are required every 6 months; expenditure reports are required annually and at project closeout. - Some flexibility in rebudgeting is allowed (up to 10% of total costs without prior approval). - No-cost extensions may be requested (typically up to 6 months). - Data and research resources generated are expected to be shared with the ALS research community. --- ## External Links - [Program Page](https://www.als.org/hugh-and-herbert-hoffman-als-impact-fund/hoffman-als-clinical-trial-awards-program) - [ALS Association Research Funding Opportunities](https://www.als.org/research/funding-opportunities) - [Information for Grant Applicants and Awardees](https://www.als.org/research/researchers/information-grant-applicants-and-awardees) - [ALS Association Grants Policy Statement](http://www.als.org/Grants-Policy-Statement) - [ProposalCentral (application portal)](https://proposalcentral.com/) --- ## Contact Information | Contact Type | Details | |-------------------|-----------------------------------------------------------------------------------| | Email | [ResearchGrants@als.org](mailto:ResearchGrants@als.org) | | Phone | +1 800-782-4747 | | Mailing Address | The ALS Association, 1300 Wilson Boulevard, Suite 600, Arlington, VA 22209, USA | | General Inquiries | [ALS Association Contact Page](https://www.als.org/contact-us) |

The Hoffman ALS Clinical Trial Awards Program

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