Gastrointestinal disease-focused US-Israeli biopharma company RedHill has received authorisation from the Italian National Institute for Infectious Diseases and Central Italian Ethics Committee for an expanded access programme for opaganib in Covid-19.
This programme will provide immediate compassionate use of RedHill's investigational drug for Covid-19 patients suffering with acute respiratory symptoms.
Opaganib is a novel, first-in-class sphingosine kinase-2 (SK2) selective inhibitor, which has shown to have anti-cancer, anti-viral and anti-inflammatory activities. Pre-clinical studies have shown it could reduce lung inflammatory disorders, such as pneumonia - one of the main symptoms of Covid-19 - as well as mitigate pulmonary fibrotic damage.
Other pre-clinical research has identified SK2 as having a role in the replication-transcription complex of positive-strand single-stranded RNA viruses, which are similar to coronaviruses.
This decision by the Italian authorities follows a similar move by the Israeli Ministry of Health; the first patient in Israel was dosed with opaganib today.
RedHill medical director Mark L. Levitt said: “The approved opaganib expanded access program allows physicians in the three major hospitals in Italy to treat patients at high risk of developing pneumonia and those with pneumonia, including acute respiratory distress syndrome, secondary to SARS-CoV-2 infection.
“RedHill is working diligently to evaluate the potential of opaganib as a treatment for Covid-19 to help patients worldwide in urgent need of a treatment option."