Expansion of Opaganib Global Phase 2/3 COVID-19 Study Planned for Patients With Severe COVID-19
A global phase 2/3 study of opaganib in patients with severe COVID-19 is set to be expanded, following FDA review of the data from the phase 2 study of the drug and RedHill Biopharma’s receipt of its recommendations.
A global phase 2/3 study of opaganib (RedHill Biopharma) in patients with severe coronavirus disease 2019 (COVID-19) is set to be expanded, following FDA review of the data from the phase 2 study of the drug and RedHill Biopharma’s receipt of its recommendations.
In a press release, RedHill Biopharma announced an expansion of the study will require adjustments to the study’s protocol, which will be based on the recommendations from the FDA and discussions within the company. Additionally, the study expansion will quicken the enrollment process, as the study will be expanded to 8 countries and approximately 40 recruiting sites in order to meet the requirements of the expansion. In the future, it is likely that additional sites and countries may be added as well.
Currently, the study is set at 464 patients, which is 50% enrolled at this time, with plans for allowing the delivery of top-line data in the second quarter of 2021.
From the non-powered phase 2 study conducted in the United States, the researchers observed top-line safety and efficacy data in patients with COVID-19 pneumonia. Specifically, opaganib demonstrated greater improvement in reducing the need for the use of oxygen by the end of treatment on day 14 of the treatment period across key primary and secondary efficacy outcomes.
The phase 2 data were also able to show no material safety differences between the opaganib and placebo treatment arms of the study, which helps to support the growing safety database for opaganib. Following a recent positive DSMB futility review for the global phase 2/3 study, the researchers noted that the potential outcome of the global phase 2/3 study is likely to be positive as well.
Opaganib is a novel, orally-administered sphingosine kinase-2 inhibitor that has been found to have antiviral, anti-inflammatory, and anti-thrombotic activity when used as a treatment. Opaganib works by targeting a human cell component involved in viral replication, allowing it to potentially be specifically effective against emerging viral variants with mutations in the spike protein.
RedHill Biopharma Announces Planned Expansion of Opaganib Global Phase 2/3 COVID-19 Study to the US. Tel Aviv, Israel: RedHill Biopharma; February 23, 2021. [email]. Accessed February 23, 2021.