FDA Clears UCLA’s ENPP1-Blocking Antibody AD-NP1 for First-in-Human Trial
The ENPP1-blocking antibody, developed in a publicly funded UCLA lab, now advances from animal data to initial testing in people.
Overview
- Phase I will primarily evaluate safety in patients with cardiac injury and track heart function, tissue regeneration, scarring, and metabolic biomarkers such as orotidine.
- Preclinical studies in mice and nonhuman primates showed restored energy metabolism, reduced fibrosis, and improved cardiac function after injury.
- AD-NP1 is a monoclonal antibody engineered to bind and inhibit ENPP1, aiming to prevent a metabolic cascade that disrupts tissue repair.
- The program was advanced entirely within UCLA with support from NIH, the Department of Defense, and CIRM, without private investment.
- UCLA plans to focus early testing on heart failure, with researchers proposing potential applications in other organs, while efficacy in humans remains unproven.