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The Hoffman ALS Clinical Trial Awards Program

The ALS Association

Title: The Hoffman ALS Clinical Trial Awards Program

Award: $1,000,000 in total funding over 2 or 3 years to support early- to mid-stage (phase 1 or phase 2a) biomarker-driven clinical trials of novel or repurposed therapeutics for ALS (either disease-modifying or symptomatic) or of imaging tracers

Key Dates

Request for Applications Open: September 23, 2025

Letter of Intent Due: November 18, 2025, 1 p.m. US ET

Full Proposal Due (by invitation only): February 17, 2026, 1 p.m. US ET

Anticipated Award Decision: May 2026

Anticipated Earliest Start Date: July 1, 2026

Award Budget

• Budgets for total costs up to $1,000,000 (inclusive of direct and indirect costs) may be requested.

• Indirect costs are limited to 10% of total direct costs.

• The Association expects that co-funding will be required to cover the full cost of the proposed trial and encourages applicants to seek additional funding sources. The Association is open to helping fill potential gaps in co-funding for awarded trials, but the availability of additional funds depends on the program budget and number of meritorious applications

AI Based Application Success Predictor

1. Central Relevance to ALS

The #1 predictor is direct applicability to ALS:

Mechanisms of motor neuron degeneration

ALS genetics (e.g. C9orf72, SOD1, TARDBP, FUS)

RNA metabolism, proteostasis, autophagy

TDP-43 pathology

Neuroinflammation & glial contributions

Neuromuscular junction preservation

Biomarkers of disease progression or therapy response

Assistive technologies to improve function, communication, breathing

Clinical interventions improving survival or quality of life

❗ General neurodegeneration or motor control research must demonstrate a solid ALS justification.

2. Perfect Fit With the Specific ALSA Mechanism

Alignment of project maturity & goals is critical:

Mechanism	Best For	Key Emphasis
Discovery Grants	Early-stage mechanisms	Innovation + preliminary rationale
Translational Grants	Preclinical therapy development	IND-enabling milestones
Clinical Trials & Biomarker Grants	Investigator-initiated studies	Recruitment & measurable endpoints
Postdoc/Early Career Awards	Trainees & new PIs	Mentorship + ALS trajectory
Tech & Care Innovation Awards	Accessibility solutions	QoL and real-world deliverability

Predictor: Show that your project is exactly what the mechanism is designed to support.

3. Strong Preliminary Data

Critical differentiator:

Proof-of-concept (cell/animal model efficacy)

Genetic or proteomic evidence supporting hypothesis

Validated AI/digital biomarkers in pilot cohorts

Verified access to ALS patients or bioresources

Reproducible assays + technical readiness

Predictor: Feasibility demonstrated through preliminary data = major reviewer confidence boost.

4. ALS-Relevant Models or Patient Cohorts

Strong proposals leverage:

iPSC-derived motor neurons from ALS patients

Inducible mouse models (SOD1, C9orf72, TDP-43, FUS)

Neuromuscular junction and muscle denervation systems

Post-mortem ALS tissue

Clinical registries & real-world datasets (e.g., NEALS network)

Predictor: Disease relevance of models is heavily weighted.

5. Clear Path to Clinical Impact

ALSA is patient mission–driven.

Competitiveness improves with:

Defined route to changes in treatment, survival, or QoL

Translation plan for therapies or biomarkers

IND-enabling milestones

Trial design elements (if applicable)

Patient-engagement strategy

Predictor: Demonstrate how this work will help people living with ALS within a realistic timeframe.

6. Strong Investigator Track Record

Reviewers assess:

Peer-reviewed publications in ALS or relevant areas

Funding history and project delivery success

Leadership or future leadership potential in ALS research

Predictor: Experience boosts scoring — particularly for mid-career and translational mechanisms.

7. High-Quality Mentorship & Career Development (for Junior Awards)

Important weighting:

Mentor with proven ALS funding & impact

Structured training and professional development

Clear path to independence (e.g., NIH K/R)

Predictor: Mentorship strength is often decisive for early-career mechanisms.

8. Collaboration & Multidisciplinary Strength

ALSA strongly encourages collaboration:

Neuroscience + immunology + bioengineering + rehab science

Partnerships with pharma/biotech (for drug development)

Participation in NEALS, ALSUntangled, or other consortia

Multi-center clinical studies

Predictor: Collaboration signals execution and scalability.

9. Rigorous, Milestone-Based Specific Aims

Most ALSA grants are short-to-mid-term (1–3 years), so proposals should provide:

2–3 testable aims

Clear measurable milestones

Go/no-go decision points

Robust statistical methodology

Contingency plans for high-risk elements

Predictor: Feasibility is a top scoring criterion.

10. Clear Writing, Figures & Compliance

Winning proposals are:

Very well organized

Supported by compelling visuals

Straightforward for clinicians and scientists to evaluate

Fully compliant with guidelines & budget constraints

Explicit about ethics, patient safety, and trial readiness (when relevant)

Predictor: Good writing directly drives reviewer enthusiasm.

🏆 Summary — ALS Association Success Predictors

Predictor	Why It Matters
ALS-specific impact	Core mission requirement
Mechanism fit	Ensures correct evaluation
Preliminary data	Feasibility & rationale
ALS models / patients	Translational value
Clinical impact	Mission alignment
PI track record	Likelihood of success
Mentorship quality	Supports independence
Collaboration	Strengthens rigor & reach
Focused aims	Deliverable progress
Strong writing	Improves scores

Specialties

Clinical Trials

Eligibility Requirements

Eligible Individuals

• Individuals with the skills, knowledge, and resources necessary to carry out the proposed research may apply as a principal investigator (PI).

• Postdoctoral fellows are not eligible to apply as a PI.

Eligible Organizations

• 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. In situations where academic investigators are partnering with industry, the academic PIs should serve as co-PIs on the grant. The exception to this would be projects where generic medications are being repurposed for ALS. Please consult with Association staff if you need clarification.

Collaborations

• The clinical trial process will likely require resources beyond those available at a single organization. Therefore, applications are open to investigators participating in synergistic collaborations.

• If a collaboration is proposed, letters confirming/supporting the collaboration are required at the full proposal stage. o Collaborative applications must identify a lead organization.

o Specific roles and responsibilities for each collaborator should be clearly articulated.

o One individual is required to serve as the PI.

• If the collaboration is multi-organizational, participating organizations will ensure the success of the collaboration by resolving potential intellectual and material property issues and by removing organizational barriers that might interfere with achieving high levels of cooperation.

Sponsor Details

Sponsor Institute/Organizations: The ALS Association

Sponsor Type: Corporate/Non-Profit

Address: 1300 Wilson Boulevard, Suite 600 Arlington, VA 22209

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