2016 NCATS/NIH R21 Grant

David Sullivan, MD, professor at Johns Hopkins Bloomberg School of Public Health has been awarded a 2-year R21 grant to investigate the preclinical activities of cethromycin in a malaria mouse model and to measure drug levels directly at the site of action in the liver.

This R21 funding mechanism supports rigorous, pre-clinical studies that establish the rationale for a clinical trial, where the hypothesis originates from use of a published or publicly available method for identifying new indications for existing drugs or biologics (therapeutics). The goal of an individual project is to explore the potential new use of an existing investigational, phase 2a-ready, or FDA-approved drug or licensed biologic; a pre-clinical study funded through this initiative will serve as a “use case” to demonstrate the utility of an independent crowdsourcing effort or of a computational algorithm to predict new uses of a drug or biologic.

Cethromycin was identified by a published quantum model computational analysis for liver- stage malaria drugs. In a limited preclinical mouse liver-stage sporozoite challenge model, cethromycin reduced the malaria parasite load using a single lower than human-equivalent dose. This R21 cethromycin preclinical mouse malaria liver-stage work will build a more solid evidence base for a phase 2 controlled human malaria infection clinical trial. The long-term outcome will be a new safe, effective malaria prophylaxis drug and/or a replacement of primaquine for the dormant liver-stage of P. vivax/ovale.