RedHill Biopharma signs research pact with Duke University School of Medicine

RedHill Biopharma (RDHL) announced the signing of a collaborative research agreement with Duke University School of Medicine outlining plans for multiple in vivo studies. The program is designed to test opaganib as a potential medical countermeasure to treat phosgene inhalation injury, aimed at providing results sufficient to advance opaganib into further definitive U.S. government-sponsored development under the U.S. FDA Animal Rule pathway to approval. The FDA Animal Rule allows for the use of pivotal animal model efficacy studies to support FDA approval of new drugs when human clinical trials are not ethical or feasible. Under this research agreement, RedHill will provide required drug quantities for animal studies, analytical support to quantify drug concentrations in plasma samples, and share dosing regimen with the Achanta Lab at Duke University.