Opaganib awarded a further $1.7 million in U.S. Government funding for development as a medical countermeasure for gastrointestinal acute radiation syndrome (ARS)
The Small Business Innovation Research (SBIR) grant, given to RedHill's development partner, Apogee, is in addition and complementary to the multimillion dollar-valued U.S. Government Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract awarded to opaganib following its selection by the RNCP for ARS development
This SBIR grant, and the earlier selection by the RNCP, follows FDA confirmation of Animal Rule regulatory pathway applicability for opaganib for ARS, utilizing pivotal animal model efficacy studies as the basis for FDA approval instead of human efficacy trials
Opaganib, a novel oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute, supporting potential central government stockpiling for use in mass casualty radiological or nuclear incidents, if approved by the FDA
Opaganib is being developed for multiple indications, including COVID-19, acute respiratory distress syndrome (ARDS), oncology and additional indications
TEL AVIV, Israel and RALEIGH, N.C., July 21, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that opaganib[1] has been awarded a further $1.7 million in U.S. Government funding, via a Small Business Innovation Research (SBIR) grant to the Company's development partner, Apogee Biotechnology Corporation ("Apogee"). This SBIR grant will support research to further the development of opaganib as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). This grant is in addition and complementary to the multimillion dollar-valued U.S. Government Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract awarded to opaganib following its selection by the RNCP for ARS development.