RALEIGH — Fresh off a small – but successful – COVID-19 study in Israel, RedHill Biopharma has received approval to test its investigational drug, opaganib, in the United States.
The Israeli specialty biopharmaceutical company, which has its U.S. commercial headquarters in Raleigh, said it has received an OK from the U.S. Food and Drug Administration to conduct a Phase 2a clinical study of opaganib. Phase 2a trials are generally designed to find out how much of a drug patients should receive to achieve the best results.
Opaganib will be given to about 40 hospitalized patients who have moderate to severe COVID-19 disease and pneumonia and who are on supplemental oxygen. The study will be placebo controlled, so half those who participate will receive the therapy and half won’t. The main objective is to measure lung improvement for up to 14 days, along with fever reduction and nasal swab tests that are negative for the virus at day 14.
Opaganib is a new orally administered sphingosine kinase-2 (SK2) inhibitor with anti-viral, anti-inflammatory and anti-cancer characteristics. The therapy can potentially reduce lung inflammation and lessen lung damage. It was originally developed by U.S.-based Apogee Biotechnology Corp., a spin-out of the Penn State College of Medicine.
“We are pleased to offer opaganib to hospitalized patients as part of a clinical study and are hopeful to meet the strong unmet need for treatments to decrease the severity and duration of respiratory symptoms due to COVID-19,” said Kevin Winthrop, M.D., MPH, the study’s principal investigator. Winthrop is a professor of infectious disease and public health at the Oregon Health and Science University-Portland State University (OHSU-PSU) School of Public Health.
RedHill has just completed a study of six COVID-19 patients who were part of a compassionate use program in Israel. The company said preliminary findings showed that all six got better within days following their treatment with opaganib. They were taken off oxygen and discharged from the hospital.
The test subjects tolerated the drug well and improved whether they were taking hydroxychloroquine, another potential COVID-19 treatment, or not.
RedHill said a total of 139 individuals have taken opaganib so far in ongoing or completed Phase 1 and Phase 2 oncology clinical studies. These trials, and the current experience with COVID-19 patients, have demonstrated the drug’s safety and tolerability, according to the company.
“We are grateful to the FDA for the timely review of our IND (investigational new drug application) and look forward to initiating the study,” RedHill Medical Director Mark L. Levitt, M.D., Ph.D., said. “There is a strong scientific rationale for the potential efficacy of opaganib in the treatment of COVID-19. This is coupled with encouraging preliminary data from the compassionate use program in Israel.”
RedHill previously announced that it also has received approval for the compassionate use of opaganib to treat about 160 COVID-19 patients with life-threatening symptoms in Italy.
The company said it plans to ramp up production of the drug if it continues to show positive clinical results and receives regulatory approval. The company’s Ireland-based strategic partner, Cosmo Pharmaceuticals, will be the main commercial supplier.
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 are based in the Capital City.
RedHill focuses on the late clinical-stage development and commercialization of drugs to treat gastrointestinal diseases and cancer. Its shares trade on the Nasdaq (symbol RDHL) and Tel Aviv stock exchanges.
(c) North Carolina Biotechnology Center