Raleigh’s RedHill Cites ‘Significant’ Results for Investigational COVID-19 Pill

RedHill Biopharma is reporting a 62% reduction in mortality for severe COVID-19 patients using its investigational oral pill-based therapy, opaganib.

 The Israeli specialty biopharmaceutical company, which has its U.S. commercial headquarters in Raleigh, said new data from its global Phase 2/3 study testing the drug also showed 21% “statistically significant” improved outcomes in time to room air and median time to hospital discharge.

“These new findings support the potential for opaganib’s use in hospitalized, moderately severe COVID-19 patients - a key group of patients that are at high risk of disease progression, morbidity and mortality, and who may benefit from opaganib’s combined antiviral and anti-inflammatory activities,” said Mark L. Levitt, MD, Ph.D., medical director at RedHill.

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 damage. It was originally developed by U.S.-based Apogee Biotechnology Corp., a spinout of the Penn State College of Medicine.

This study included a group of 251 hospitalized patients. Opaganib was given to 117 hospitalized patients who had moderate to severe COVID-19 disease and pneumonia and who were on supplemental oxygen. The study was placebo controlled, so the remaining patients didn’t receive the therapy. The main objective was 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.

The result: seven deaths in the 117-patient opaganib arm versus 21 deaths in the 134-patient placebo arm. 

Data indicates “a potential meaningful benefit with opaganib for these hospitalized, moderately severe COVID-19 patients - a group at high risk of disease progression, morbidity and mortality; the data also supports opaganib’s potential use in earlier stages of COVID-19 disease, consistent with opaganib’s U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants,” the company said.

“We are excited about this promising and robust dataset,” said Dror Ben-Asher, RedHill’s CEO. “We are not aware of any other novel oral pill-based therapy that has shown a similar magnitude of difference in the mortality outcomes of hospitalized patients who are at this moderately severe stage of disease.”

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 them in Raleigh.

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.