Tel Aviv: Israel-based biopharmaceutical company RedHill Biopharma’s new oral pill called Opaganib has been found effective in patients hospitalised with COVID-related pneumonia, results from a clinical trial has shown.
The oral opaganib is associated with a reduction in the need for supplemental oxygen support, earlier time to discharge from hospital and was well tolerated, the company said in a statement on Monday.
The Phase II trial analysed data from the 40-patient who were randomised to receive either opaganib or placebo in addition to standard of care (SoC), predominantly including dexamethasone and/or remdesivir.
About 86.4 percent of patients treated with opaganib were discharged from hospital by Day 14 compared to 55.6 percent of patients treated with placebo. The findings were presented at the World Microbe Forum, taking place online from June 20 to 24.
“Presentation of these positive data from our exploratory Phase 2 study support our growing confidence that opaganib could be the first novel oral therapy to demonstrate efficacy in the treatment of COVID-19 in a large late-stage study. With the recent completion of enrollment of our 475-patient global Phase 2/3 study, we will have a clearer picture of that in the very near future,” said Mark L Levitt, Medical Director at RedHill.
“Opaganib acts on both the cause and effect of COVID-19 via a unique dual antiviral and anti-inflammatory mode of action. Being host-targeted, opaganib is also expected to maintain effect against the emerging SARS-CoV-2 variants, which continue to threaten the progress being made against the pandemic and underscore the urgent need for effective COVID-19 therapeutics,” Levitt added.
Opaganib is orally-administered and has a sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity. It targets the host and is therefore expected to be effective against emerging viral variants. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue.
Additionally, preclinical in vivo studies have demonstrated opaganib’s potential to ameliorate inflammatory lung disorders, such as pneumonia, and has shown decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids, the company said.