RedHill Biopharma Ltd., a specialty biopharmaceutical company, has signed 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. Food and Drug Administration’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.
 
“Opaganib is currently being tested, by various governmental research bodies, in multiple areas that urgently require new chemical and medical countermeasure therapeutic options,” said Dr. Satya Achanta, D.V.M., Ph.D., Assistant Professor in the Department of Anesthesiology at Duke University School of Medicine. “Our research will help determine whether there is a potential protective role of opaganib in limiting damage caused by phosgene inhalation.”
 
“Notably used as a chemical weapon during World War I, phosgene, a toxic, colorless chemical, is today widely used in industrial processes for the manufacture of plastics and pesticides. The U.S. Environmental Protection Agency (EPA) identified 123 sites in the United States that could expose millions of people to phosgene potentially due to plant malfunction or bioterrorism,” said Gilead Raday, RedHill’s Chief Operating Officer and Head of Research and Development. “This exciting collaboration with Duke University School of Medicine could pave the way to a potential therapy for the acute respiratory distress syndrome (ARDS) phosgene inhalation can cause, which can be extremely dangerous, causing significant, even fatal, injury. No known approved antidote or reversal agent currently exists, and, if approved, opaganib may provide potential for stockpiling for emergency use in the event of a major public safety incident.”