RALEIGH – Finally, a little encouraging news on the COVID-19 coronavirus front.

RedHill Biopharma, an Israeli specialty company with U.S. commercial headquarters in Raleigh, reports that all six COVID-19 patients who recently received its investigative drug, opaganib, got better.

Opaganib is a new first-in-class orally administered sphingosine kinase-2 (SK2) inhibitor with anti-viral, anti-inflammatory and anticancer characteristics. The therapy can potentially reduce lung inflammation and lessen lung damage.

RedHill said all patients who were part of a compassionate use program in Israel “demonstrated objective significant measurable clinical improvement” within days of receiving opaganib. Five of the six people suffering from moderate-to-severe respiratory symptoms were taken off oxygen altogether. Three were discharged from the hospital. A sixth patient, whose treatment started later, continues to recover.

All the test subjects tolerated opaganib well and improved whether they were taking hydroxychloroquine, another potential COVID-19 treatment, or not.

RedHill Biopharma, which has US HQ in Raleigh, pursues second COVID-19 treatment

A seventh patient who received hydroxychloroquine and the antibiotic azithromycin developed diarrhea and got only one day’s treatment of opaganib. That individual wasn’t included in the analysis, RedHill pointed out.

“These preliminary findings are highly encouraging, show clinical improvement in the first COVID-19 patients treated with opaganib and provide preliminary support for the tolerability of opaganib and its potential efficacy in COVID-19 patients,” said Mark L. Levitt, M.D., Ph.D., RedHill’s medical director. Levitt added that the company has submitted an application with the U.S. Food and Drug Administration to conduct a similar opaganib study in the United States.

RedHill also has received approval for compassionate use in coronavirus patients in Italy. Physicians in three major hospitals in the northern part of that country, which has been hard-hit by COVID-19, plan to use the drug to treat about 160 people with life-threatening symptoms.

Opaganib already has been tested on 131 cancer patients and healthy volunteers in the U.S. as part of Phase 1 and Phase 2 oncology clinical trials. Levitt said the trial data demonstrate the drug’s safety and tolerability.

RedHill plans to ramp up production of opaganib if it continues to show positive clinical results and receives regulatory approval. The company’s Ireland-based strategic partner, Cosmo Pharmaceuticals, will become the main commercial supplier.

RedHill Looks at COVID-19 Potential of Another Drug

RedHill also is exploring the potential of another one of its investigational drugs as a COVID-19 treatment. Under an agreement with the National Institute of Allergy and Infectious Diseases, the company will conduct non-clinical testing of RHB-107. This therapy is a first-in-class orally administered protease inhibitor that targets pancreatic cancer and inflammatory gastrointestinal diseases.

Some COVID-19 patients in Italy to receive RedHill drug; firm has US HQ in Raleigh

The treatment was evaluated in more than 300 people across 10 clinical studies and proved to be safe and well-tolerated, according to RedHill. It is under pre-clinical analysis for COVID-19. If tests are successful, RHB-107 could move to human trials.

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

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

(C) N.C. Biotech Center