RedHill Biopharma Ltd. (Nasdaq: RDHL), a specialty biopharmaceutical company, has announced positive in vivo results from a new pre-clinical study evaluating the effects of opaganib[1] on radiation-induced hematologic and renal toxicity, undertaken by RedHill and its partner Apogee Biotechnology Corporation ("Apogee"). The results, suggesting that opaganib exerts a protective impact on key hematological and kidney function parameters following total body irradiation (TBI), are consistent with recently published U.S. government-funded in vivo opaganib data[2] and are further supportive of opaganib's planned development under the Animal Rule for nuclear radiation protection.
Lynn W. Maines, PhD., Apogee's VP of Research, said: "These results, as well as the established scientific understanding that disruption of S1P production reduces damaging pathologic inflammation, further support the hypothesis that opaganib's inhibition of SK2, and subsequent reduction S1P production, suppresses Heme-ARS and kidney damage by lethal total body irradiation, and may play a key role in protecting against generalized radiation injury."
"These new results add to, and are consistent with, the positive indications towards opaganib's radioprotective capabilities reported in the recent peer-reviewed International Journal of Molecular Sciences (IJMS) publication and support further studies of opaganib in this indication," said Dr Mark Levitt, MD, PhD, Chief Scientific Officer at RedHill. "Our assessment of the pathway towards approval, and following recent discussions with key government agencies, gives us an understanding of the progress already made, and of the areas of ongoing work still to be completed, which we believe can be done in an expedited manner given the prevailing need for new radioprotective treatment options."
Recently published, U.S. government funded results, from eight preclinical studies and additional experiments, indicate opaganib's potential as a nuclear radiation injury therapeutic for homeland security material threat medical countermeasures (MCM) and for antitumor radiotherapy. These results indicate that opaganib may protect normal tissue from damage due to ionizing radiation exposure or cancer radiotherapy, improve antitumor activity and response to chemoradiation, and enhance tolerability and survival.
Opaganib is a novel oral small molecule sphingosine kinase 2 (SK2) inhibitor that is potentially suitable to current government research priorities for material threat medical countermeasures suitable for central stockpiling for use in mass casualty nuclear radiation incidents. Opaganib can be administered 24 hours or later after radiation exposure, is highly stable with a more than five-year shelf-life, easy to administer and distribute, and demonstrated its clinical safety profile in various human clinical studies and expanded access uses in other indications.
Multiple discussions with government agencies in the U.S. and internationally are ongoing regarding funding and medical countermeasure development pathways.
Sponsors of approved medical countermeasures product applications may be eligible for a medical countermeasure Priority Review Voucher.
