Antiviral Program for Pandemics

NCATS will play a pivotal role in the Antiviral Program for Pandemics (APP), a multi-agency initiative to develop safe and effective oral antivirals. The initial priority for the APP is to develop treatments for SARS-CoV-2 and other coronaviruses, with the program expanding to address other virus families with pandemic potential.

Launched in June 2021 with more than $3 billion in funding from the American Rescue Plan, the APP will accelerate the development of a portfolio of promising antivirals that can quickly pivot to combat future pandemics. Having safe and effective oral antiviral candidates ready for deployment in later-stage clinical trials against a newly emergent virus would save lives, reduce serious illness and prevent overwhelming surges in hospitalizations during a viral outbreak or pandemic.

Accelerating Antiviral Development

As part of the APP, NCATS will be a key partner alongside the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to accelerate antiviral development through early discovery and preclinical development. NCATS also will coordinate with partners to take candidates into clinical development.

NCATS will apply its proficiency in drug discovery and development and its cutting-edge technologies to fill critical needs of the APP, such as target validation; high-throughput screening (HTS) for drug starting points; medicinal chemistry for lead optimization; and preclinical, investigational new drug (IND)-enabling development.

Specific NCATS activities will include:

• novel assay development for viral targets, including Biosafety Level 2 and Biosafety Level 3 assays
• compound testing to characterize activity across virus families
• HTS of diverse collections of chemical compounds to identify drug development starting points
• hit-to-lead optimization of promising compounds, from preliminary structure-activity relationship exploration to full-scale medicinal chemistry studies
• rigorous evaluation of drug metabolism and pharmacokinetic (DMPK) properties, exploratory toxicology to demonstrate initial safety, and validation of efficacy in relevant in vivo systems
• preparation of comprehensive data packages for inclusion in IND applications to the U.S. Food and Drug Administration

In addition to SARS-CoV-2, NCATS’ activities will address other viruses within the scope of the APP that represent known threats because of their pandemic potential. The table below shows virus families/orders and examples of viruses that the APP may target.

Opportunities for Collaboration with NCATS

NCATS will partner with extramural scientists and the private sector to advance drug discovery and development programs for oral antiviral candidates. NCATS can collaborate on projects with entry points anywhere along the development pipeline — and with flexible project exit points — to accelerate discovery and overcome the scientific, technical and enterprise barriers to delivering drug candidates ready for Phase 2 clinical trials in future pandemics.

To learn more about partnering with NCATS and the Center’s role in the APP, please contact app@ncats.nih.gov.