BioPharma

Roche starts Phase III study of arthritis drug in Covid-19 pneumonia

The company said the trial had been launched last week, comparing Actemra against placebo in patients hospitalized with pneumonia due to Covid-19. Other trials looking at the drug are underway in Italy and China.

One of the largest companies selling lab testing equipment amid the Covid-19 pandemic has also started a Phase III clinical trial of a drug to treat pneumonia associated with the disease.

Swiss drugmaker Roche said Tuesday that it had launched the trial last Thursday, testing Actemra (tocilizumab) added to standard of care in patients hospitalized with severe pneumonia related to Covid-19, the disease caused by the SARS-CoV-2 virus. The company said the trial is being run under collaboration with the Biomedical Advanced Research and Development Authority, which is under the Department of Health and Human Services and is helping to sponsor a number of trials of various drugs and vaccines for Covid-19.

Although Covid-19 mostly manifests as a flu-like disease in young and healthy patients while being far more dangerous and fatal to those who are elderly or have underlying health conditions, it has been known to cause severe pneumonia in patients of all age groups, even otherwise healthy ones in their 20s and 30s. One of the most worrisome aspects of the disease is the number of people requiring breathing assistance, although there is in many countries – including the U.S. – a shortage of ventilators and intensive care unit beds.

Roche noted that the trial, titled COVACTA, is the first global study of Actemra in Covid-19-related pneumonia. Another trial, a Phase II study conducted by the National Cancer Institute in Naples, Italy, is also testing Actemra in 330 Covid-19 patients around the country with pneumonia. Also underway are a 30-patient Phase II study looking at the drug in pneumonitis – inflammation of the walls of the lungs – sponsored by Marche Polytechnic University and a 150-patient trial testing Actemra with Fujifilm’s favipiravir at Peking University in Beijing.

Other drugs under investigation for Covid-19 include Gilead Sciences’ remdesivir, Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab) and the generic malaria and autoimmune disorder drug hydroxychloroquine. Sanofi, Moderna and others are additionally developing vaccines, and Moderna announced last week that it had dosed the first patient in the Phase I study of its vaccine, mRNA-1273.

Actemra has Food and Drug Administration approval for treating autoimmune disorders like rheumatoid arthritis and other arthritic diseases, as well as cytokine release syndrome, a common autoimmune side effect caused by CAR-T cell therapies in patients with blood cancers.

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A Deep-dive Into Specialty Pharma

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