RedHill Biopharma Ltd (NASDAQ:RDHL) announced Friday that the independent Data Safety Monitoring Board (DSMB) has thrown their support behind the global Phase 2/3 study of orally-administered opaganib in patients with severe coronavirus (COVID-19).
The biopharmaceutical company said that the DSMB had unanimously recommended to continue the study following a pre-scheduled futility review of unblinded efficacy data from the first 135 patients treated in the study and safety data from the first 175 patients.
Mark Levitt, RedHill’s medical director, called the positive recommendation a “significant milestone” in the development program.
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“Taken together with the positive results from the Phase 2 study, this unanimous DSMB recommendation to continue the global Phase 2/3 study suggests we are heading in the right direction from both a safety and efficacy perspective,” Levitt told investors in a statement.
“This is a particularly difficult time in the fight against the pandemic, with viral mutations increasing infection rates and impacting many aspects of society’s response to the pandemic. The need for effective therapeutics is clear.”
Opaganib is a novel, sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity – taken in simple capsule form.
Opaganib’s mechanism of action targets the human host cell component SK2, which is involved in both viral replication inside the cell and downstream inflammatory/immune responses, meaning the treatment is expected to maintain its activity despite the mutations in SARS-CoV-2 spike protein.
Levitt noted that the mutations “underscore the potential of SARS-CoV-2 to develop resistance to direct anti-viral mAbs, and to potentially impact vaccine effectiveness. This is an important advantage of opaganib in the face of the growing multitude of viral strains and provides the promise of a much-needed treatment option to help get patients off oxygen and out of hospital.”
In a recent US Phase 2 study, opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14 across key primary and secondary efficacy outcomes, in line with clinical improvement as defined by the World Health Organization (WHO) ordinal scale. The Phase 2 data also showed no material safety differences between the opaganib and placebo treatment arms – further adding to the growing safety database for opaganib.
Top-line data and potential global emergency use authorization applications are expected in the second quarter of 2021. RedHill also recently announced a manufacturing agreement with Cosmo Pharma to further expand manufacturing capacity for opaganib, to address prospective demand subsequent to potential global emergency use authorizations. This is in addition to several previously announced agreements with suppliers in the US Canada and Europe.
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