RedHill Biopharma’s opaganib shows radioprotective activity in study

RedHill Biopharma (RDHL) announced positive results from new in vivo studies of opaganib as a treatment for gastrointestinal acute radiation syndrome, or GI-ARS, undertaken as part of the U.S. government’s Radiation and Nuclear Countermeasures Program – RNCP – product pipeline development contract awarded to opaganib, that further confirm opaganib’s protective activity in models of GI-ARS. The company, together with the National Institutes of Allergy and Infectious Diseases – NIAID -, which leads the U.S. government’s RNCP, now plan to discuss the next phase of opaganib’s U.S. government-funded development, along the FDA’s Animal Rule pathway, as a medical countermeasure against GI-ARS. The FDA’s Animal Rule pathway to approval allows for pivotal animal model efficacy studies to support FDA approval of new drugs when human clinical trials are not ethical or feasible. Opaganib is a novel, orally administered small molecule, clinical-stage drug with demonstrated safety & efficacy profiles, being developed for various oncology, viral infections, inflammatory diseases and chemical and nuclear/radioprotection indications.