RALEIGH – RedHill Biopharma is another step closer to getting one of its potential treatments for COVID-19 tested.
The Israeli company, which has its U.S. headquarters and commercial operations in Raleigh, got the green light to provide its investigational drug, RHB-107 (upamostat, WX-671), for testing in non-clinical studies against the coronavirus.
It’s part of an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
RHB-107 is a proprietary, first-in-class orally administered protease inhibitor targeting pancreatic cancer and inflammatory gastrointestinal diseases. According to RedHill, it presents a new, non-cytotoxic approach to cancer therapy.
The drug has already been studied in more than 300 people across 10 clinical studies, including two completed Phase 2 studies in oncology patients and several Phase 1 studies in healthy volunteers and oncology patients. RedHill said these studies helped establish the safety and tolerability of RHB-107 in humans.
It will now be used for in vitro testing against COVID-19, which, if successful, could lead to testing in humans for treating the disease.
“RHB-107 is the second investigational drug that RedHill is evaluating for COVID-19, underscoring our commitment to the global efforts to develop a treatment for patients with this disease,” said Terry F. Plasse M.D., medical director at RedHill.
“This new agreement will facilitate pre-clinical evaluation of RHB-107 as a potential COVID-19 treatment.”
A second possible treatment?
Separately, Red Hill is investigating another novel drug, opaganib (Yeliva, ABC294640), as a potential treatment for COVID-19.
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.
A compassionate use program for COVID-19 patients is currently underway in Israel.
“Several patients [have been] treated to date, with preliminary positive outcomes,” Red Hill said in its release. The firm is under discussions in other countries for similar compassionate use.
Meanwhile, it has submitted an Investigational New Drug application to the U.S. Food and Drug Administration to evaluate opaganib in a clinical study in adults diagnosed with COVID-19 and pneumonia.