RedHill Announces Additional U.S. Government Funding for Opaganib Nuclear Countermeasure Development

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.

The mission of the SBIR programs is to support scientific excellence and technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy. 

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)^[2].”

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. A recent publication in the International Journal of Molecular Sciences, entitled “Opaganib Protects against Radiation Toxicity: Implications for Homeland Security and Antitumor Radiotherapy” describes the collective results of eight U.S. Government-funded in vivo studies by Apogee, as well as additional experiments, establishing opaganib’s potential radiation protection capabilities^[3]. 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^[4].

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.

About Acute Radiation Syndrome (ARS)

ARS, sometimes known as radiation toxicity or radiation sickness, is generally rare; however, public health emergencies, such as a nuclear power plant accident or detonation of a nuclear device, could affect large numbers …

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