RedHill Biopharma Ltd. has entered into a collaborative research agreement with Duke University School of Medicine to evaluate opaganib as a potential treatment for phosgene inhalation injury. The collaboration will involve multiple in vivo studies designed to support the advancement of opaganib through the U.S. Food and Drug Administration's (FDA) Animal Rule pathway.
FDA Animal Rule and Study Design
The FDA Animal Rule allows for the approval of new drugs based on animal model efficacy studies when human clinical trials are not ethical or feasible. Under the agreement, RedHill will supply opaganib for animal studies, provide analytical support for quantifying drug concentrations in plasma samples, and share dosing regimens with the Achanta Lab at Duke University.
Opaganib's Potential
"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."
Phosgene Exposure and Current Treatment Landscape
Phosgene, a toxic and colorless chemical, was notably used as a chemical weapon during World War I and is now widely used in industrial processes for manufacturing plastics and pesticides. The U.S. Environmental Protection Agency (EPA) has identified 123 sites in the United States where millions of people could potentially be exposed to phosgene due to plant malfunction or bioterrorism.
The Need for a Phosgene Inhalation Treatment
According to Gilead Raday, RedHill's Chief Operating Officer and Head of Research and Development, this collaboration with Duke University School of Medicine could pave the way for a potential therapy for the acute respiratory distress syndrome (ARDS) caused by phosgene inhalation. ARDS can be extremely dangerous, causing significant, even fatal, injury. Currently, there is no approved antidote or reversal agent for phosgene inhalation. If approved, opaganib may offer a potential option for stockpiling for emergency use in the event of a major public safety incident.
