RedHill Biopharma has rolled snake eyes in a late-stage trial for its experimental COVID-19 treatment, the SK2 inhibitor opaganib, which has failed to help severely ill patients.
Top-line data dropped Tuesday morning from the Israeli biotech for a randomized, double-blind, parallel-arm, placebo-controlled phase 2/3 test made up of 475 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.
The primary endpoint of the study is the proportion of patients breathing room air without oxygen support after two weeks, but opaganib failed to hit statistical significance in this group.
RedHill's failure is the latest in a series of new and repurposed drugs from various biotechs and pharmaceutical companies that have struggled to help patients once they become severely ill over the past 18 months.
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Like other companies, however, RedHill isn’t giving up. The biotech is eyeing a path to use opaganib in less sick patients who are earlier on in the course of their disease.
And RedHill is looking for glimmers of hope in the trial, just like other biotechs that have tried to salvage a COVID-19 failure. The biotech is still analyzing the data but did see “trends in favor of the opaganib arm vs. placebo across multiple endpoints, including the primary endpoint, despite not achieving statistical significance.” The top-line data also "showed good tolerability of opaganib."
Redhill pointed to data from a small phase 2 as further positives. Those data, published at the start of the year, linked the 40-subject trial to a numerical improvement in total oxygen requirement but was too small to provide conclusive answers.
This all feels pretty weak—and sounds familiar to other biotechs that have tried to spin failures in COVID-19 into wins—but RedHill still thinks that together, these glimmers could turn into something brighter.
“These findings, together with preliminary analysis pointing to increased benefit in a subset of patients requiring less oxygen, could support the potential utilization of opaganib in earlier stages of the disease and are in line with the previously announced results from the U.S. phase 2 study and the previously observed antiviral activity of opaganib,” RedHill said in a statement.
Redhill's shares sank more than 32% in premarket trading Tuesday to $4.95, compared to a prior close of $7.38.
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RedHill will now talk through the data with the FDA “to help determine next steps.”
The biotech also has another orally administered drug candidate, RHB-107 (upamostat), which is being trialed in a midstage test in non-hospitalized symptomatic COVID patients. The drug recently received an approval for a study in South Africa and an expansion within the U.S.