TEL-AVIV, Israel & RALEIGH, N.C.—Specialty biopharmaceutical company RedHill Biopharma Ltd. announced this week 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 RHB-107 for testing in nonclinical studies for activity against SARS-CoV-2, the virus that causes the coronavirus disease COVID-19.
RHB-107 (upamostat, WX-671) is an investigational 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 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.
And this isn't the company’s first time throwing its hat into the COVID ring.
“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 Dr. Terry F. Plasse, medical director at RedHill. “This new agreement will facilitate preclinical evaluation of RHB-107 as a potential COVID-19 treatment.”
The other novel investigational drug for potential treatment of SARS-CoV-2 infection is opaganib (Yeliva, ABC294640). A compassionate use program of opaganib is underway in Israel, with several patients treated to date demonstrating preliminary positive outcomes, according to the company.
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.
In fact, RedHill has already announced that it has received authorization from the Italian National Institute for Infectious Diseases and Central Italian Ethics Committee for an expanded access program, which will allow immediate compassionate use of opaganib in Italy for patients with confirmed COVID-19 infection with life-threatening clinical manifestations.
Approximately 160 patients are planned to be treated in three major hospitals in northern Italy, one of the current major epicenters of the pandemic.
In other recent company news—completely unrelated to infectious disease—RedHill announced that it has completed the recently announced acquisition of the global rights, excluding Europe, Canada and Israel, to Movantik (naloxegol) for the treatment of opioid-induced constipation (OIC) from AstraZeneca. Movantik is the first oral peripherally acting mu-opioid receptor antagonist approved in the United States for OIC.
Said Adi Frish, senior vice president of business development and licensing at RedHill: “We are delighted to add Movantik to our GI-focused commercial basket. We will continue to aggressively drive both organic and non-organic growth following the launches of Aemcolo and Talicia and the acquisition of Movantik.”