- The Novartis anti-inflammatory medicine canakinumab failed to help patients hospitalized with COVID-19 in a Phase 3 clinical trial, the Swiss drugmaker reported Friday.
- Canakinumab, a rare disease drug sold as Ilaris, missed both its primary and secondary goals in the study, which tested the treatment alongside standard of care in people with COVID-19-associated pneumonia and an inflammatory response known as cytokine release syndrome, or CRS. Although the data slightly favored canakinumab, the differences in COVID-19 outcomes for treated patients versus those on placebo were not significant.
- The result is another setback in a global effort to repurpose various anti-inflammatory drugs for very sick COVID-19 patients — an effort now even more critical as infection rates rise the U.S., Europe and elsewhere. A few drugs have been shown to be modestly beneficial, while studies of many other medicines have either failed outright or produced mixed results.
Coronavirus vaccines and engineered antibody drugs, even if soon proven safe and effective, will likely be in short supply until next year.
And while those interventions could help prevent infection or COVID-19, effective treatments are still desperately needed for people already very sick, especially as the coronavirus makes a fall resurgence around the globe.
Since very early on in the pandemic, drugmakers have pushed forward with tests of existing anti-inflammatory medicines, hoping these treatments might tamp down the overactive immune reactions seen in the advanced stages of COVID-19, among them CRS and acute respiratory distress.
The push, which has involved many dozens of studies across the globe, has so far resulted in more setbacks than successes, however.
The only drugs that have been proven to help COVID-19 patients and are widely available — Gilead's Veklury and the steroid dexamethasone — are for people who are already hospitalized with the infectious disease. But Veklury's benefit is, at best, modest, and dexamethasone appears most helpful only for those who are gravely ill.
A rheumatoid arthritis drug from Eli Lilly, called Olumiant, was also recently shown to help speed patient recovery when added to Veklury and might soon be cleared for emergency use by the Food and Drug Administration.
Other repurposed drugs have disappointed, though. Roche's Actemra, an arthritis drug widely seen as promising for late-stage COVID-19, has had mixed results. Sanofi and Regeneron's Kevzara, which works similarly to Actemra, failed multiple trials.
Novartis' canakinumab, an antibody used to treat rare inflammatory diseases, now seems set to follow.
The pharma had hoped the drug might help keep more severe COVID-19 patients alive or off of ventilators. More than 450 COVID-19 patients hospitalized with either pneumonia or CRS were enrolled in Novartis' study, which compared Ilaris plus standard of care to placebo and standard treatment. Participants had low levels of oxygen, but weren't yet intubated or on mechanical ventilation.
Results disclosed by Novartis Friday showed canakinumab met neither of the study's goals. After 29 days, about 90% of canakinumab-treated patients were still alive without needing ventilation, slightly more than the roughly 86% of placebo patients, but not so much more that the difference couldn't be the result of chance.
Some 4.9% of canakinumab patients had died after 29 days, compared to 7.2% of those who received placebo — a difference that was, again, not statistically significant.
"Though the CAN-COVID trial did not show the patient benefit we were hoping for, it helps improve the scientific understanding of COVID-19 and the role of interleukin-1β inhibition," said Novartis chief medical officer John Tsai, referring to canakinumab's mechanism of action. The company will submit the results to a peer-reviewed medical journal.
Novartis will now turn its attention to its remaining coronavirus treatment efforts, among them an ongoing Phase 3 study of the myelofibrosis drug Jakafi and a recent alliance with Molecular Partners to develop oral drugs to treat or prevent infections.