A Triangle pharmaceutical organization has received special approval from the Italian government for use of its drug in the fight against COVID-19.
Raleigh’s RedHill – an Israeli company with operations in the Triangle – has announced that the Italian National Institute for Infectious Diseases has granted it immediate compassionate use of its investigational drug opaganib for patients with COVID-19 in the European nation that’s been overwhelmed by the virus.
The drug is earmarked specifically for patients with life-threatening symptoms. It is currently planned to be used in 160 patients in hospitals in northern Italy, the hardest-hit region of the country.
According to the company’s medical director, Dr. Mark Levitt, the approval allows Italian physicians to treat patients “at high risk of developing pneumonia and those with pneumonia” – including acute respiratory distress syndrome (ARDS).
Opaganib is being developed for anticancer, anti-viral and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. Pre-clinical data has shown it has the potential to reduce lung inflammatory disorders, such as pneumonia.
A total of 131 subjects have been dosed with opaganib to date in ongoing and completed Phase 1 and Phase 2 clinical studies in oncology indications in the U.S. RedHill says clinical work has established necessary safety and tolerability standards in humans.
The company says “discussions are ongoing in the U.S. and other countries” to explore the potential use of the drug. Cosmo Pharmaceuticals is the main commercial supplier of the drug based on an existing strategic partnership.
“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,” Levitt says.
News of the approval sent RedHill (Nasdaq: RDHL) stock up nearly 20 percent, trading at $5.60 per share at close of markets Monday.
The extra momentum comes as the company is launching commercial efforts for its newly approved asset, Talicia, and just after RedHill secured a $115 million loan and acquiring a new drug.
Original Article Source: Triangle Business Journal