Letter of Intent due May 17, 2023
The ALS Association’s Clinical Trial Awards Program supports early to mid-stage interventional clinical trials of novel or repositioned therapeutics for ALS.
The ALS Association is the largest philanthropic funder of ALS research worldwide. Our goal is to make ALS livable for everyone, everywhere, until we can cure it. To achieve this goal, there is an urgent need for new and improved therapies. The Clinical Trial Awards (CTA) Program provides up to $1,000,000 in total funding over 2 or 3 years to support the clinical testing of novel or repositioned approaches for ALS. Both disease-modifying and symptomatic treatments are in scope. The CTA Program seeks to de-risk clinical programs by supporting clinical trials with clear go/no-go criteria that, if positive, will attract follow-on funding and enable further development. This program is open to industry and academic investigators.
Scope / Type of Trials Supported
• Clinical stage: 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 single ascending dose (and multiple ascending dose) studies to assess safety/tolerability and studies assessing brain penetration or target engagement in healthy subjects and/or people living with ALS.
• Trial population: Can include genetic or sporadic forms of ALS, healthy subjects, and/or asymptomatic carriers of ALS-linked genetic mutations.
• Therapeutic approaches: Novel or repositioned approaches for ALS (either disease-modifying or symptomatic), including small molecules, genetic therapies, stem cell approaches, peptides, antibodies, and antisense oligonucleotides.
Please note: This funding opportunity will not support clinical trials of non-pharmacological or surgical interventions, observational studies, or natural history studies. In addition, 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 also required, with a new IND (or similar) application submitted no later than 3 months after the project start date.
Key Dates and Deadlines
• Letter of Intent Due Date: May 17, 2023, 5 p.m. U.S. EDT
• Full Proposal Due Date (by invitation only): August 2, 2023, 5 p.m. U.S. EDT
• Anticipated Award Decision: October 2023
• Anticipated Earliest Start Date: November 2023
For more details on the program and how to apply, click here.