Funder: Dept. of the Army -- USAMRAA
Due Dates: June 6, 2025 (Pre-application) | August 27, 2025 (Full application, by invitation)
Funding Amounts: Up to $2,000,000 total costs per award over 3 years; approx. $10.5M available for ~5 awards.
Summary: Supports empirical, product-driven preclinical to IND-enabling ALS therapeutic development, requiring proof-of-concept and biomarker integration.
Key Information: Clinical trials are not permitted; lead compounds and preclinical efficacy data are required at application.
Description
This award supports research focused on advancing therapeutic candidates for Amyotrophic Lateral Sclerosis (ALS) from preclinical validation through FDA Investigational New Drug (IND)-enabling studies. Projects must be empirical, product-driven, and begin with lead compounds that have already demonstrated proof-of-concept efficacy in at least one preclinical ALS model system. A critical component is the concurrent development of mechanism-specific, predictive, or pharmacodynamic biomarkers relevant to the therapeutic approach. Projects that only focus on biomarker development for diagnosis, prognosis, or general disease progression, or that propose candidates already granted an IND, are not eligible. Clinical trials are not allowed under this mechanism.
Due Dates
- Pre-Application (required): June 6, 2025, 5:00 p.m. Eastern Time
- Invitation to Submit Full Application: July 10, 2025
- Full Application (by invitation): August 27, 2025, 11:59 p.m. Eastern Time
- End of Application Verification Period: September 3, 2025, 5:00 p.m. Eastern Time
Funding Amount
- Total Program Funding: Approximately $10.5 million
- Expected Number of Awards: ~5
- Maximum Award: Up to $2,000,000 total costs (direct + indirect) per award
- Project Duration: Up to 3 years
Eligibility
- Eligible Applicants: Unrestricted — open to extramural and intramural organizations, including:
- Academic institutions
- Biotechnology companies
- Nonprofits and foundations
- For-profit organizations
- Public and private entities, domestic and foreign
- Principal Investigators: Independent investigators at all career levels; organizations must designate the PI.
- Other Requirements:
- Must have an active SAM.gov registration and UEI.
- Applications must be submitted by eligible organizations, not individuals.
- No cost sharing or matching required.
- Lead compounds and proof-of-concept efficacy data in a preclinical ALS model are required at submission.
- Clinical trials are not permitted.
Application Process
Step 1: Pre-Application (Required)
- Submit via eBRAP.
- Components include a 3-page narrative, references, key personnel biosketches, and list of abbreviations.
- Pre-application deadline: June 6, 2025.
- Only invited applicants may submit a full application.
Step 2: Full Application (By Invitation Only)
- Submit via Grants.gov (extramural) or eBRAP (intramural DoD).
- Components include:
- Project Narrative (12 pages)
- Supporting documentation
- Technical and lay abstracts
- Statement of Work
- Biomarker and Impact Statements
- Transition Plan
- Budget and justification
- Biosketches and current/pending support
- Other required forms as specified in the announcement
- Full application deadline: August 27, 2025.
Additional Information
- Biomarker Requirement: All applications must include a biomarker development plan linked to the therapeutic approach.
- Clinical Specimens: Use of pre-existing, well-characterized human biospecimens is permitted; new collection is not supported.
- Clinical Trials: Not allowed; preclinical and IND-enabling work only.
- Review Process: Two-tiered (peer and programmatic review) based on scientific merit and relevance to ALSRP goals.
- Reporting: Annual and final technical progress reports required; additional post-award requirements may apply.
- Foreign Affiliations: Disclosure of foreign affiliations for all key personnel is mandatory.
External Links
- Funder Home Page (CDMRP)
- Official Grants.gov Listing
- Program Announcement (PDF)
- eBRAP Application Portal
- SAM.gov Registration
Contact Information
Contact | Details |
---|---|
CDMRP Help Desk | Phone: 301-682-5507 Email: help@eBRAP.org |
Grants.gov Support | Phone: 800-518-4726 Email: support@grants.gov |