The Alzheimer's Drug Discovery Foundation invites Letters of Intent for its Program to Accelerate Clinical Trials.
The goal of the foundation's PACT program is to increase the number of innovative pharmacologic interventions tested in the clinic for Alzheimer's disease and related dementias. The PACT RFP supports clinical trials, experimental medicine, and regulatory studies for novel drugs (small molecules and biologics, including antibodies, peptides, gene therapies), repurposed drugs (existing drugs that are approved for other diseases and conditions), repositioned drugs (existing drugs that have entered clinical trials for other indications and have not yet been approved), and natural products. Specifically, the program will fund:
Early Stage Human Clinical Trials — Including phase 0 micro- or sub-therapeutic-dosing studies, phase 1 single ascending dose and multiple ascending dose studies, and phase 2a biomarker-based proof-of-concept or proof-of-mechanism studies. Studies can validate novel molecular targets in humans and de-risk novel therapeutic approaches earlier in clinical development by assessing the potential efficacy of therapeutic interventions using pharmacodynamic outcomes.
Regulatory Studies — Including non-GLP and GLP pharmacology and toxicology studies, and scale-up, pre-formulation, and GMP manufacture required for investigational new drug (IND) and clinical trial authorization (CTA) preclinical packages (funding is available for preparation of traditional and exploratory IND applications); and long-term toxicology studies to enable longer-term dosing in phase 2 trials (if not completed prior to phase 1 studies), as well as GMP manufacture and testing of clinical grade drug required to move into phase 2 or phase 3 trials.
Current target areas of interest include but are not limited to neuroprotection, inflammation, vascular function, mitochondria and metabolic function, proteostasis, ApoE, epigenetics, synaptic activity and neurotransmitters, and other aging targets (e.g., senescent cells).
Up to $5 million will be awarded based on stage and scope of research. For studies requiring additional support, co-funding from other funding agencies or investors is encouraged.
The RFP is open to researchers and clinicians worldwide at academic medical centers, universities, nonprofits, and biotechnology companies. Existing companies and new spinouts are both eligible, and industry partnerships are strongly encouraged.
Letters of Intent must be received no later than July 12. Upon review, selected applicants will be invited to submit a full proposal by August 9, 2019.
For complete program guidelines and application instructions, see the Alzheimer’s Drug Discovery Foundation website.