* Roche presses on with own Actemra trial
* Questions linger over inflammation drugs for COVID-19
* Actemra sales rose 30% in Q1 on pandemic demand (Adds reference to Italy’s drugs regulator starting in 2nd paragraph, background on trials of similar drugs)
By Emilio Parodi and Carl O’Donnell
Despite the setback, the Swiss drugmaker said that it is pressing ahead with testing Actemra in another trial against COVID-19, the disease caused by the new coronavirus.
Actemra did not reduce severe respiratory symptoms, intensive care visits, or death any better than standard treatments, the Italian Medicines Agency (Aifa), Italy’s drugs regulator which authorized the study, said in a statement on Wednesday.
The trial, which enrolled 126 patients, about a third of the intended number, was stopped early after an interim analysis raised doubts about the anti-inflammatory medicine’s effectiveness.
“Although not effective in all patients with COVID-19 pneumonia, it is possible that selected subgroups of patients may have a better response,” Aifa said.
Sales of Actemra jumped 30% in the first quarter, Roche said in April, on hopes it would help in the fight against the new coronavirus.
Its failure to do so in the Italian study now adds to questions about the role of drugs like Actemra, which are designed to inhibit interleukin-6 (IL-6) proteins associated with dangerous inflammation, in treating COVID-19.
A similar IL-6 inhibitor, Sanofi and Regeneron’s arthritis drug Kevzara, failed in a trial in April to help a group comprised of severely ill and critically ill patients, leading the drugmakers to continue to test high doses of Kevzara only in those considered critically ill with COVID-19.
Detailed data from the Italian Actemra study, which involved 24 medical centres, will be sent to a scientific journal.
Meanwhile, Roche has completed enrolment of its own Actemra study in patients hospitalized with severe COVID-19 pneumonia. That “will provide robust evidence about the benefit/ risk profile”, a Roche spokesman said, with data expected in the next few months.
Last month Roche also announced plans to study whether combining Actemra with Gilead Sciences Inc’s antiviral treatment remdesivir works better against severe COVID-19 pneumonia than remdesivir alone.
Remdesivir has shortened hospital stays of COVID-19 patients. (Reporting by Carl O’Donnell in New York, Emilio Parodi in Milan, Ludwig Burger in Frankfurt and John Miller in Zurich Editing by Chris Reese/Bill Berkrot/Susan Fenton)