Swiss pharmaceuticals and diagnostics company Roche on Wednesday announced that its Actemra/RoActemra drug has failed to treat patients hospitalised with severe COVID-19-related pneumonia.
The drugmaker said, “COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality.
“In addition, the key secondary endpoints, which included the difference inpatient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra. The COVACTA study did not identify any new safety signals for Actemra/RoActemra. Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal.
“However, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra. The COVACTA study did not identify any new safety signals for Actemra/RoActemra. Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal.”
Roche announcement on the failure of the drug is seen as a major setback in the ongoing researches and efforts to get a cure for the coronavirus pandemic as “The study is the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting.”
“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.
Continuing Garraway said, “We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic.”
Not deterred by the failure of the trial drug, Roche said, “It remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral.”
The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.
Read the full statement by Roche