Roche has stepped on the gas in testing Actemra for coronavirus patients, thanks to a little more help from the U.S. government.
With $25 million in backing from the U.S. Biomedical Advanced Research and Development Authority (BARDA), the Swiss drugmaker will speed up Actemra’s phase 3 trial in COVID-19 patients, the agency said Tuesday.
The BARDA grant is part of an expanded partnership Roche’s Genentech signed with the agency to accelerate clinical trials of Actemra, an IL-6 inhibitor that could help fend off the severe lung inflammation that hits some patients.
The drug won a speedy FDA go-ahead last month to be evaluated on top of standard of care to treat patients with severe COVID-19 pneumonia.
Currently approved to treat rheumatoid arthritis, Actemra is one of a suite of IL-6 inhibitors running through their paces in clinical trials as possible COVID-19 therapeutics. Last month, Roche said it was upping production of the drug to meet an expected increase in demand, despite the fact the drug hasn’t yet been proven effective in treating patients with the disease.
Sanofi and Regeneron have also launched global clinical trials for their IL-6 med Kevzara, with the first patient in the ex-U.S. arm of the program dosed in late March.
The Kevzara program will enlist severe or critically ill patients who’ve been hospitalized in Italy, Spain, Germany, France, Canada and Russia, and the drugmakers are working to “secure initiation at additional sites,” Regeneron said in a release at the time. The trial will eventually enroll around 300 patients and study intravenous Kevzara as an add-on to supportive care, Regeneron said.
Earlier in the month, Sanofi and Regeneron had announced the U.S. arm of the program, saying the stateside trial would test Kevzara as an add-on to supportive care in around 400 patients across 16 states.
A third IL-6 inhibitor, EUSA’s Sylvant, entered an observational study in Bergamo, Italy’s Papa Giovanni XXIII Hospital in mid-March. The study is evaluating Sylvant’s ability to reduce the need for invasive ventilation, time spent in intensive care and 30-day mortality for patients, either prior to intensive care or those already admitted to ICU units, EUSA said.
Sylvant is approved in the U.S. to treat patients with multicentric Castleman disease who are HIV- and herpes-negative.
The IL-6 class is part of a concerted effort by the pharmaceutical industry to evaluate and repurpose older, approved meds as possible therapies for COVID-19 patients as the pandemic continues to rage.
Tuesday, Alexion announced it would take rare disease med Soliris into a phase 2 clinical trial as a possible therapeutic in the next few days. The study would follow a 10-patient proof-of-concept trial in which “patients improved in general,” a source told GlobalData.
Novartis and Incyte said earlier this week they would initiate a phase 3 clinical trial for Jakafi––marketed as Jakavi abroad––to treat cytokine storm, an immune overreaction that causes respiratory complications in severe COVID-19 patients. The blinded, double-arm study will evaluate a combination of Jakafi alongside standard-of-care therapy to treat COVID-19 patients with pneumonia, the partners said.