Data from a post hoc analysis of a phase 2/3 study of oral opaganib in COVID-19 pneumonia showed a 62% reduction in mortality and a 21% improvement in time to room air.
RT’s Three Key Takeaways:
- Opaganib Reduced Mortality by 62%: In the post-hoc analysis of the phase 2/3 study, hospitalized COVID-19 patients requiring oxygen support with FiO2 levels ≤60% experienced a 62% reduction in mortality by day 42 after receiving opaganib compared to placebo.
- Improved Oxygen Independence: By day 14, 21% more patients treated with opaganib no longer required supplemental oxygen for at least 24 hours, demonstrating a potential benefit in respiratory recovery for patients with moderate oxygen needs.
- FiO2 as a Potential Biomarker: The study suggests that an FiO2 level of greater than 60% may serve as a threshold for disease severity, potentially acting as a biomarker for selecting appropriate COVID-19 patients for opaganib treatment.
Biopharmaceutical company RedHill Biopharma Ltd announced the publication of data from the 57-site, randomized, placebo-controlled, double-blind phase 2/3 study of opaganib in COVID-19 pneumonia.
The post hoc analysis of data from 251 study participants showed that hospitalized COVID-19 patients requiring a fraction of inspired oxygen (FiO2) up to and including 60% (FiO2≤60%) had better outcomes after 14 days’ opaganib treatment (n=117) compared to placebo (n=134).
There was a clinically meaningful 62% reduction in mortality by day 42. Additionally, the proportion of patients with FiO2≤60% at baseline that no longer required supplemental oxygen (≥24 hours) by day 14 of opaganib treatment increased by 21%. The safety profile for opaganib was similar to placebo.
The data also indicated that FiO2 of greater than 60% may represent a threshold level for disease severity which could be utilized as a biomarker.
The study is published in Microorganisms.
Opaganib’s Potential in COVID-19 Treatment
“These published post-hoc study data suggest a distinct treatment benefit in hospitalized COVID-19 patients requiring an FiO2 of ≤60%. This, supported by additional data such as lower inflammatory markers and higher lymphocyte counts, and added to a favorable safety profile, point to the potential of opaganib to be an effective new oral therapy for hospitalized COVID-19 patients, warranting further investigation,” says Mark Levitt, MD, PhD, chief scientific officer at RedHill, in a release. “Of significant additional interest is the insight that baseline FiO2 requirement may be a new clinical biomarker for patient selection and potentially have a major impact on how hospitalized COVID-19 patients are managed in the future.”
Opaganib, an investigational host-directed and potentially broad-acting drug, is an orally administered sphingosine kinase-2 selective inhibitor with anticancer, anti-inflammatory, and antiviral activity, targeting multiple potential indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome, Sulfur Mustard exposure, COVID-19, Ebola, and other viruses as part of pandemic preparedness.
