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Duchenne Muscular Dystrophy

NEWS RELEASE

Released: April 1, 2025

Department of Defense
Defense Health Agency Research and Development -
Medical Research and Development Command
Congressionally Directed Medical Research Programs (CDMRP)
Duchenne Muscular Dystrophy Research Program
Anticipated Funding Opportunities for Fiscal Year 2025 (FY25)

The Full-Year Continuing Appropriations and Extensions Act of 2025 provides $650M in funding for the CDMRP. Congress provided further guidance for CDMRP program-level funding, including funding for the Duchenne Muscular Dystrophy Research Program (DMDRP). The FY25 DMDRP intends to support research addressing Duchenne Muscular Dystrophy (DMD) pathobiology, diagnosis, and treatment. The CDMRP is part of the Defense Health Agency Research and Development at the U.S. Army Medical Research and Development Command (USAMRDC) and is the program office managing these anticipated FY25 funding opportunities.

The DMDRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY25 funding opportunities. This pre-announcement should not be construed as an obligation by the government. The FY25 DMDRP funding opportunity announcements for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the announcements are released.

Applications submitted to the FY25 DMDRP Idea Development Award must address opportunities and challenges in the development of safe and effective macromolecular and cellular therapies that focus on the primary pathology of DMD. Therapies that will be efficacious across the lifespan, including infants, toddlers, and nonambulatory individuals are strongly encouraged.

Studies proposed under this award may include:

  • Preclinical testing of combination therapies with small molecules and/or biologics that have existing human clinical data in DMD or repurposed from other disorders
  • Optimized delivery to specific tissues or cell types, including targeting to skeletal muscle, heart, brain, and muscle stem cells (e.g., ligand-assisted delivery, tissue-specific promoters, nanoparticles, alternative vectors, identification of biological barriers to delivery)
  • Strategies to overcome preexisting immunity and to facilitate repeat administration of biologic therapies (e.g., immune system modulation, vector modification)
  • Repopulation of the muscle compartment using cell-based therapies, including, but not limited to, selection of novel cell types, expansion, cell delivery and homing, differentiation, and integration
  • Non-genomic therapies that are downstream from the genetic defect to address disease pathogenesis (e.g., mitochondrial dysfunction, inflammation, fibrosis, fatty infiltration, etc.)
  • Research that will inform and improve therapy in individuals ineligible for currently approved or in-development therapeutics (e.g., age, type of mutations, seropositivity, rare exons)
  • Discovery and validation of novel targets, including genetic modifiers and factors that determine the selective vulnerability/resistance of individual muscles, especially in humans
  • Validation of novel models to address human pathophysiologies in DMD beyond skeletal muscle (e.g., smooth muscle)
  • Therapies that address muscle regeneration deficits

Studies in the following research areas will not be supported by this award mechanism:

  • Testing the efficacy of candidate therapeutics without a strong mechanistic rationale
  • Evaluation of vectors or delivery technologies already prevalent in research studies (e.g., AAV9)

All applications for the FY25 DMDRP Clinical/Translational Research Award must address at least one of the following focus areas:

Preclinical Translational Research

  • Extension or expansion of existing preclinical data in support of Investigational New Drug application-enabling studies. For example:
    • Optimizing delivery to target tissues
    • Drug exposure
    • Independent replication
    • Comparative studies
    • Assay development, outcome measures, and/or biomarkers (e.g., pharmacodynamic, prognostic, or predictive biomarkers, including potential surrogate markers)

Clinical Research

  • Clinical studies designed to improve care and quality of life
  • Prospective real-world data/post market studies for combination or sequential therapies, and/or long-term safety and efficacy studies
  • Assessment of clinical trial tools and outcome measures
    • In understudied systems (e.g., cognitive, cardiac, or gastrointestinal [GI]) or age ranges (e.g., infants, toddlers, and/or nonambulatory)
    • Discovery and qualification of pharmacodynamic, prognostic, and predictive biomarkers, including potential surrogate markers
    • Novel clinical outcome assessment
    • Patient-centered outcomes (e.g., quality of life, activities of daily living)
    • Secondary data analysis that helps to address clinical research tool validation
  • Natural history studies in understudied systems (e.g., cognitive, cardiac, GI) or age ranges (e.g., infants, toddlers, and/or nonambulatory adults) with an aim toward clinical trial readiness

Award Mechanism Eligibility Key Mechanism Elements Funding
Idea Development Award Established Investigators: Independent investigators at or above the level of Assistant Professor (or equivalent).

New Investigators - Early Stage: Investigators that meet the following criteria by the application submission deadline date:
  • Have not previously received a DMDRP Idea Development Award.
  • Are within 10 years of first faculty appointment (or equivalent).

New Investigator - Transitioning: Established investigators in an area other than muscular dystrophy at or above the level of Assistant Professor seeking to transition to a career in DMD, thereby bringing their expertise to the field.
Investigators must pursue an active line of research in DMD and commit at least 10% of their efforts during each budget year toward the proposed DMD research project.
  • Supports the development of innovative, high-impact ideas that advance the understanding of DMD and ultimately lead to improved outcomes.
  • Must address opportunities and challenges in the development of safe and effective macromolecular and cellular therapies that address primary pathology of DMD. Therapies that will be efficacious across the lifespan, particularly in adolescents and adults, are encouraged.
  • Preliminary data required.
  • Clinical trials or applications including a clinical trial aim are not allowed.
  • Maximum funding of $350,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 2 years
Clinical/Translational Research Award Independent investigators at all academic levels.

Early-Career Partnering Principal Investigator (PI) Option:
  • The Partnering PI must be an independent, early-career investigator within 10 years of their first faculty appointment by the time of application submission. Lapses in research time or appointments as denoted in the biographical sketch should be explained in the application.

It is encouraged, but not required, that the partnering PI is a clinician or clinical scientist (M.D. or M.D./Ph.D.) to increase collaboration between clinical and nonclinical aspects of DMD research.
  • Supports translational studies that have moved beyond the realm of basic research and have the potential to result in a near-term impact in clinical research or the clinic.
  • Research projects investigating therapies that will be efficacious across the lifespan, particularly in adolescents and adults, are strongly encouraged.
  • Preliminary data required.
  • Clinical trials are allowed.
  • Different funding levels, based on the scope of research, are available. It is the responsibility of the PI to select the funding level that is most appropriate for the research proposed. The funding level should be selected based on the scope of the research project, rather than the amount of the budget.

The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under each funding level:
  • Funding Level 1: Supports smaller, less complex preclinical and/or clinical research. Pilot clinical trials are allowed.
  • Funding Level 2: Intended to support larger, more complex preclinical and/or clinical research. Pilot clinical trials are allowed.
 Funding Level 1
  • Maximum funding of $650,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Funding Level 1 - Partnering PI Option
  • Maximum funding of $750,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Funding Level 2
  • Maximum funding of $1.25 million (M) for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years
Funding Level 2 - Partnering PI Option
  • Maximum funding of $1.35M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final funding opportunity announcements that will be available for downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Submission deadlines are not available until the funding opportunity announcements are released. For email notification when announcements are released, subscribe to program-specific news and updates under "Email Subscriptions" on the eBRAP homepage at https://eBRAP.org. For more information about the DMDRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).

Point of Contact:
CDMRP Public Affairs
301-619-9783
dha.detrick.cdmrp.mbx.public-affairs@health.mil


Last updated Tuesday, April 1, 2025