Trialect

+ More Filters

Reset Filters

Specialty

Funding Organization

Funding Type

Eligible Country

Deadline

From

Other (Select all that apply)

Show Expired Programs

Show Verified Programs

Verified

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) clinical trials of novel/repositioned therapeutics for ALS (either disease-modifying or symptomatic) or of imaging tracers in people living with ALS

Funding Opportunity Description
2.1.1 Award Overview
There is an urgent need for new and improved therapies for ALS, as there is still no cure. 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 ALS Association’s Hoffman ALS Clinical Trial Awards Program seeks to de-risk clinical programs of novel or repositioned approaches for ALS by providing up to $1,000,000 in total funding over 2 or 3 years to support early- to mid-stage trials (phase 1 or phase 2a). Both disease-modifying and symptomatic treatments are in scope, as are early trials testing imaging tracers in people living with ALS. This year, we are particularly interested in funding programs targeting TDP-43 and/or protein aggregation. Funding will be prioritized for trials with a clear biological rationale and an integrated biomarkers strategy, and where clinical outcomes are aligned with the trial phase.
These awards are open to industry and academic investigators. Successful applicants will provide strong preclinical data supporting the biological rationale for the proposed treatment/tracer and a clear plan for clinical development. Biomarker-driven clinical trials, along with other methods for increasing the probability that trials definitively answer relevant scientific questions, are strongly recommended. Long-term development plans should describe essential “go/no-go” decision milestones and a plan to attract follow-on funding if results are positive.

Type of Clinical Trials Supported
To be eligible for this funding opportunity, proposed studies should:
•
Be early to mid-phase (phase 1 or phase 2a) interventional trials exploring safety or biomarkers to justify larger phase 2b or phase 3 studies. This includes:
o
Single and multiple ascending dose studies to assess safety/tolerability.
o
Studies assessing brain penetration or target engagement in healthy subjects and/or people living with ALS.
•
Test novel or repositioned approaches for ALS (either disease-modifying or symptomatic), including:
o
Small molecules
o
Antisense oligonucleotides and other genetic therapies
o
Stem cell approaches
o
Peptides
o
Antibodies
•
Include people living with genetic or sporadic forms of ALS, healthy subjects, and/or asymptomatic carriers of ALS-linked genetic mutations.
•
Or alternatively, be early trials testing an imaging tracer in people living with ALS.

To review the topics of previously funded projects, please visit our website. This year, we are particularly interested in funding programs targeting TDP-43 and/or protein aggregation.
2.1.3 Trials Not Supported by This Funding Opportunity 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
•
Expanded access protocol (EAP) studies

Additional Considerations
•
The therapeutic should have completed or be in the process of completing Investigational New Drug (IND)-enabling studies by the time the full proposal is due.
•
IND (or similar regulatory authority) approval is required for projects selected for funding, meaning at the time of the award, the applicant should either:
o
Have an approved IND application (or similar if outside the U.S.) in hand,
o
Have submitted an IND application (or similar) and have approval pending, or
o
Commit to filing a new IND application (or similar) within 3 months of the project start date.
o
Please note: Records of any correspondence, meeting minutes, etc. with regulatory authorities should be submitted at the full proposal stage.
•
Successful applications will:
o
Include a clear biological rationale for the target biology and pathway.
o
Include a strong and compelling preclinical data package providing the rationale for the proposed treatment/tracer moving to the clinical stage.
o
Have an integrated biomarkers program.
o
Propose clinical outcomes that are aligned with the trial phase.
o
Provide a clear plan, including “go/no-go” decision milestones, for moving the approach through the essential stages of clinical development.
o
Describe what additional funding sources are in hand already or will be pursued to fund the entire trial (e.g., government, private/VC investors, industry partnerships, etc.).
•
If selected for funding, the Association recommends posting the trial on www.clinicaltrials.gov. We also encourage sharing of biosamples with the NEALS Sample Repository and data with the PRO-ACT database.

Specialties

Clinical Trials

Healthcare Delivery

Pharmacology

Genetics & Genomics

Neurosciences

Technology Development

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, except in situations where a generic medication is 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

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

Legal & Affiliation Disclaimer

Affiliation Disclaimer: Trialect operates independently and is not affiliated with, endorsed by, or supported by any sponsors or organizations posting on the GrantsBoard platform. As an independent aggregator of publicly available funding opportunities, Trialect provides equal access to information for all users without endorsing any specific funding source, content, organization, or sponsor. Trialect assumes no responsibility for the content posted by sponsors or third parties.

Subscription Disclaimer: Upon logging into Trialect, you may choose to SUBSCRIBE to GrantsBoard for timely notifications of funding opportunities and to access exclusive benefits, such as priority alerts, reminders, personalized recommendations, and additional application support. However, users are advised to contact sponsors directly for any questions and are not required to subscribe to engage with funding opportunities.

Content Ownership and Copyright Disclaimer: Trialect respects the intellectual property rights of all organizations and individuals. All content posted on GrantsBoard is provided solely for informational purposes and remains the property of the original owners. Trialect does not claim ownership of, nor does it have any proprietary interest in, content provided by third-party sponsors. Users are encouraged to verify content and ownership directly with the posting sponsor.

Fair Use Disclaimer: The information and content available on GrantsBoard are compiled from publicly accessible sources in alignment with fair use principles under U.S. copyright law. Trialect serves as an aggregator of this content, offering it to users in good faith and with the understanding that it is available for public dissemination. Any organization or individual who believes their intellectual property rights have been violated is encouraged to contact us for prompt resolution.

Third-Party Posting Responsibility Disclaimer: Trialect is a neutral platform that allows third-party sponsors to post funding opportunities for informational purposes only. Sponsors are solely responsible for ensuring that their postings comply with copyright, trademark, and other intellectual property laws. Trialect assumes no liability for any copyright or intellectual property infringements in third-party content and will take appropriate action to address any substantiated claims.

Accuracy and Verification Disclaimer: Trialect makes no warranties regarding the accuracy, completeness, or reliability of the information provided by sponsors. Users are advised to verify the details of any funding opportunity directly with the sponsor before taking action. Trialect cannot be held liable for any discrepancies, omissions, or inaccuracies in third-party postings.

Notice and Takedown Policy: Trialect is committed to upholding copyright law and protecting the rights of intellectual property owners. If you believe that content on GrantsBoard infringes your copyright or intellectual property rights, please contact us with detailed information about the claim. Upon receipt of a valid notice, Trialect will promptly investigate and, where appropriate, remove or disable access to the infringing content.

View Funding Opportunity