Opaganib Phase 2/3 Data Shows 62% COVID-19 Mortality Reduction

A recent publication in the peer-reviewed journal Microorganisms has disclosed significant findings from a post hoc analysis of a phase 2/3 clinical trial involving the drug opaganib. The study, conducted by RedHill Biopharma Ltd., explored the efficacy of opaganib in treating COVID-19 pneumonia. The trial was extensive, involving 57 different sites and a total of 251 hospitalized patients with moderately severe COVID-19 who required a fraction of inspired oxygen (FiO2) of up to 60%.

The analysis revealed that patients treated with opaganib (n=117) had notably better outcomes compared to those who received a placebo (n=134). Specifically, there was a 62% reduction in mortality among patients treated with opaganib, with mortality rates of 5.98% in the opaganib group versus 16.7% in the placebo group by day 42. Additionally, the proportion of patients who no longer required supplemental oxygen for at least 24 hours by day 14 was significantly higher in the opaganib group, showing a 21% improvement compared to the placebo group (76.9% vs. 63.4%).

These findings suggest that opaganib could be a promising treatment for COVID-19 pneumonia, particularly for those requiring up to 60% FiO2. The study also highlighted that FiO2 levels greater than 60% might serve as a threshold for disease severity, potentially acting as a biomarker for patient selection in future therapeutic strategies.

The need for effective COVID-19 treatments remains urgent. According to the World Health Organization, 30,000 Americans have died from COVID-19 this year alone. The data from this study provides new hope for reducing mortality and improving recovery times for hospitalized COVID-19 patients.

Opaganib is a novel, orally administered small molecule drug that has shown potential in treating various conditions, including viral infections, oncology indications, and inflammatory diseases. Its safety and efficacy profiles have been demonstrated in multiple studies. The drug works through multiple pathways, including inhibiting sphingolipid-metabolizing enzymes, which are crucial for viral replication and inflammation.

Dr. Mark Levitt, Chief Scientific Officer at RedHill, commented on the study's findings, emphasizing the ongoing need for effective COVID-19 treatments. He noted that while the immediate emergency of the pandemic might have subsided, the virus continues to cause hospitalizations and deaths. The data from this study support further investigation into opaganib as a viable treatment option for COVID-19 pneumonia.

Opaganib's host-directed mechanism of action, which involves the inhibition of sphingosine kinase-2 (SPHK2), makes it a unique therapeutic candidate. It has demonstrated antiviral activity against multiple viruses, including SARS-CoV-2, Influenza A, and Ebola. Notably, in a U.S. Army study, opaganib significantly improved survival times in an Ebola virus model, showcasing its broad antiviral potential.

In addition to COVID-19, opaganib is being evaluated for other indications, including various cancers, gastrointestinal acute radiation syndrome, and exposure to harmful agents like sulfur mustard. It has received several orphan-drug designations from the FDA and has shown positive results in preclinical and early clinical studies for multiple conditions.

RedHill Biopharma Ltd. specializes in developing and commercializing treatments for gastrointestinal and infectious diseases. The company's portfolio includes drugs for Helicobacter pylori infection and travelers' diarrhea, and it is actively pursuing late-stage development programs for several other conditions.

In conclusion, the newly published data on opaganib offers promising insights into its potential as an effective treatment for COVID-19 pneumonia. The significant reduction in mortality and improvement in recovery times observed in the study underscore the need for further research and development of this novel therapeutic.

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