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Drug Development RFP (Alzheimer’s Disease worldwide)

Alzheimer’s Drug Discovery Foundation

The Drug Development RFP supports investigational new drug (IND)-enabling studies (or the international equivalent) and early-phase clinical trials that test promising pharmacological interventions and devices for Alzheimer’s disease (AD) and related dementias. This funding opportunity concentrates on diverse drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia.

ADDF strategic priorities include:

Combination therapies of two or more drugs to be administered together or development of combination products. This may include:
- co-development of two or more new investigational drugs
- a single new investigational drug in combination with a previously approved anti-amyloid monoclonal antibody
- fixed combinations of two previously approved drugs
Disease-modifying and symptomatic agents

Stage of development:

1. Early-stage human clinical trials including:

Phase 0 micro- or sub-therapeutic-dosing studies
Phase 1 trials in healthy subjects or patients
Biomarker-based proof-of-concept studies (generally phase 1b or phase 2a trials) designed to assess target engagement and downstream pharmacologic effects

2. IND (or international equivalent) – enabling studies including:

Non-GLP and GLP pharmacology and toxicology studies, pre-formulation, and GMP manufacture of API and/or drug product required for regulatory packages. Funding is available for preparation of traditional and exploratory IND (or international equivalent) applications
Long-term toxicology studies to enable longer-term dosing in phase 2 trials
GMP manufacturing and testing of API and/or drug product required to move into phase 2 or phase 3 trials

For clinical trial applications, if IND-enabling work is in progress, funding for clinical studies would be contingent upon an IND (or equivalent) successfully going into effect.

Type of therapy: Novel, repurposed and repositioned drugs, as well as natural products and devices will be considered. Therapeutic modalities of interest include small molecules, peptides, antibodies, gene therapies, antisense oligonucleotides, and stem cells. Other non-pharmacologic interventions, such as diet, meditation, and exercise, will not be considered. A detailed landscape analysis to compare competition related to the mode or mechanism of action is strongly encouraged.

Drug mechanisms or modes of action: Novel drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia are considered high priority. These include, but are not limited to:

Epigenetics
Inflammation
Mitochondrial & metabolic function
Neuroprotection
Proteostasis
Synaptic activity and neurotransmitters
Vascular function
Other mechanisms and modes of action related to the biology of aging (e.g. senescent cells)
Other novel mechanisms or modes of action that are supported by compelling evidence demonstrating a rational biological connection to the disease process

AWARD INFORMATION

Award Amount
Up to $5,000,000 based on stage and scope of research. For studies requiring additional support, co-funding from other funding agencies or investors is encouraged. Payment structure will be negotiated and based on milestone achievements and recruitment.

Average Duration
Multi-year

Allowable costs
Only direct costs are allowed. Please review our Funding Policies

Specialties

Clinical Trials

Drug Development

Neurosurgery

Drug Delivery

Neurosciences

Pharmacology

Eligibility Requirements

Funding is open to researchers and clinicians worldwide at:

Academic medical centers and universities or nonprofits. Industry partnerships are strongly encouraged.
Biotechnology companies. Existing companies and new startups are both eligible.
NOTE: Funding is provided through mission-related investments that require return on investment based upon scientific and/or business milestones (see Our Research Strategy for more information).

Sponsor Details

Sponsor Institute/Organizations: Alzheimer’s Drug Discovery Foundation

Address: 57 West 57th Street, Suite 904 New York, NY 10019 info@alzdiscovery.org 212.901.8000

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