Italian COVID-19 Patients to Receive Investigational RedHill Drug

RedHill Biopharma has joined a growing list of companies with North Carolina ties that are seeking solutions to the global coronavirus pandemic.

The Israeli company has located its U.S. headquarters and commercial operations in Raleigh.

The specialty biotech said its investigational drug opaganib has been approved for compassionate use in a small number of coronavirus patients in Italy. The expanded access authorization, which will test the effectiveness of the therapy in treating COVID-19, comes from the Italian National Institute for Infectious Diseases and the Central Italian Ethics Committee. 

Opaganib is a new first-in-class – orally administered – sphingosine kinase-2 (SK2) inhibitor with anti-viral, anti-inflammatory and anticancer characteristics, according to RedHill. Originally developed by U.S.-based Apogee Biotechnology Corp., the drug targets oncology, inflammatory and gastrointestinal disorders. RedHill said the therapy has the potential to reduce lung inflammation and to lessen lung damage.

“The treatment of COVID-19 patients with opaganib is supported by pre-clinical data demonstrating its unique anti-viral activity in a number of other viruses, as well as its anti-inflammatory activities and potential to reduce lung inflammation,” said RedHill’s Medical Director Mark L. Levitt, M.D., Ph.D. 

Physicians in three major hospitals in northern Italy, a current epicenter for the pandemic, plan to use opaganib to treat approximately 160 COVID-19 patients who have life-threatening symptoms.

“The approved opaganib expanded access program allows physicians...to treat patients at high risk of developing pneumonia and those with pneumonia, including acute respiratory distress syndrome secondary to the SARS-COV-2 infection,” Dr. Levitt explained. “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.”

Another patient in Israel with respiratory problems related to COVID-19 has recently been dosed with opaganib at a leading hospital there. RedHill said the treatment was administered under the Israeli Ministry of Health’s compassionate use guidelines. More patients in that country will likely be treated soon.

“We are working toward making opaganib available to additional patients in Israel and other countries under compassionate use programs,” Levitt noted. 

The drug already has been tested on 131 subjects in the United States as part of Phase 1 and Phase 2 oncology clinical trials. Levitt said clinical data to date have demonstrated its safety and tolerability in both healthy volunteers and cancer patients.

RedHill said it is preparing to ramp up production of opaganib if the new therapy demonstrates positive clinical results and receives regulatory approval. The company’s strategic partner, Cosmo Pharmaceuticals, of Ireland, will become the main commercial supplier.

RedHill Biopharma was established in 2009 in Tel Aviv and opened its U.S. headquarters in Raleigh in 2017. The company said it has some 160 employees in its U.S. commercial operations, about 40 of whom are based in the Raleigh headquarters.

 It focuses on the late clinical-stage development and commercialization of drugs to treat gastrointestinal diseases and cancer. The company’s shares are traded on the Nasdaq (symbol RDHL) and the Tel Aviv stock exchanges.