RedHill Biopharma Ltd., a specialty biopharmaceutical company, reported that opaganib 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 Corp. The 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.

In an ARS setting, opaganib is thought to exert its protective effects via an anti-inflammatory mechanism of action involving ceramide elevation and reduction of sphingosine 1-phosphate. This is believed to reduce inflammatory damage to normal tissue and thus suppress toxicity from unintended ionizing radiation exposure. 

In the relevant study models, opaganib was associated with protection of normal tissue, including the GI tract, from damage due to ionizing radiation exposure from total-body exposure. Additional independent studies demonstrate the role of inhibition of sphingosine kinase-2 (SPHK2), the primary target of opaganib, in radioprotection in bone marrow, with knockout of SPHK2 showing enhanced survival in mice irradiated with lethal doses of whole-body radiation.

According to the company, 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 nuclear radiation incidents, if approved.

Dror Ben-Asher, CEO of RedHill Biopharma, said: “In light of ongoing regional geo-political instabilities, it is important for us to bring together all the pieces of the development jigsaw for opaganib as a potential medical countermeasure for acute radiation syndrome. Opaganib is now being supported by several multimillion dollar-valued government grants. This latest additional U.S. Government funding from the SBIR, in addition to the RNCP development collaboration, is expected to help ensure that we and our partner Apogee can rapidly progress opaganib’s development for ARS. In parallel, we plan to continue our existing collaborations and discussions with other U.S. Government agencies and other governments regarding opaganib for ARDS, COVID-19 and other indications, as well as for our other new chemical entity (NCE) under clinical development, RHB-107 (upamostat).”