Tel Aviv: A clinical trial found that the Israeli biopharmaceutical company RedHill Biopharma’s new oral pill Opaganib was effective in patients hospitalised with COVID-related pneumonia.
The company said in a statement on Monday that the oral opaganib is associated with a reduction in the need for supplemental oxygen support, an earlier time to discharge from the hospital, and was well tolerated.
The data from the Phase II trial were analysed from 40 patients who were randomly assigned to receive either opaganib or placebo in addition to standard of care (SoC), which primarily included dexamethasone and/or remdesivir.
By Day 14, approximately 86.4 percent of patients treated with opaganib had been discharged from the hospital, compared to 55.6 percent of patients treated with placebo. The findings were presented at the World Microbe Forum, which ran from June 20 to June 24 online.
“The positive results of our exploratory Phase 2 study add to 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. We will have a clearer picture of that in the very near future, thanks to the recent completion of enrollment in our 475-patient global Phase 2/3 study “RedHill’s Medical Director, Mark L Levitt, stated
“Opaganib works on both the cause and the effect of COVID-19 through a novel dual antiviral and anti-inflammatory mechanism. Because it is host-targeted, opaganib is expected to maintain its effect against emerging SARS-CoV-2 variants, which continue to jeopardise pandemic progress and highlight the critical need for effective COVID-19 therapeutics “Levitt continued.
Opaganib is an orally administered sphingosine kinase-2 (SK2) selective inhibitor with anti-inflammatory and antiviral properties. It is designed to attack the host and is thus expected to be effective against emerging viral variants. Opaganib has also demonstrated anticancer activity and the potential to treat a wide range of oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib inhibited viral replication in an in vitro model of human lung bronchial tissue, demonstrating potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19.
Furthermore, preclinical in vivo studies have demonstrated opaganib’s potential to alleviate inflammatory lung disorders such as pneumonia, as well as decreased fatality rates from influenza virus infection and alleviated Pseudomonas aeruginosa-induced lung injury by lowering IL-6 and TNF-alpha levels in bronchoalveolar lavage fluids, according to the company.