RedHill Biopharma Ltd. announced that it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to provide its investigational drug, RHB-107 (upamostat, WX-671), for testing in non-clinical studies for activity against SARS-CoV-2, the virus that causes coronavirus disease (COVID-19).
RHB-107, an investigational new chemical entity, has 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. These studies helped establish the safety and tolerability of RHB-107 in humans. RHB-107 is a serine protease inhibitor active against a number of human trypsins and several other related serine proteases. Inhibition of serine proteases, including trypsins, may inhibit viral attachment and replication and decrease lung damage from viral pneumonia.
RHB-107 was selected by NIAID for in vitro testing, following evaluation by NIAID of data on the drug’s possible mechanism of action and potential activity against SARS-CoV-2.
“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 MD, Medical Director at RedHill. “This new agreement will facilitate pre-clinical evaluation of RHB-107 as a potential COVID-19 treatment.”
In parallel with the RHB-107 program, RedHill is evaluating another novel investigational drug, opaganib (Yeliva®, ABC294640), as a potential treatment for SARS-CoV-2 infection. A compassionate use program of opaganib is underway in Israel, with several patients treated to date, with preliminary positive outcomes. In order to facilitate access to opaganib, various programs are currently under discussions in other countries and an Investigational New Drug (IND) application was submitted to the U.S. Food and Drug Administration (FDA) to evaluate opaganib in a clinical study in adults diagnosed with COVID-19 and pneumonia.