Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the initiation of a global Phase III, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra® (tocilizumab) plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.
“As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe disease. We’re pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”
The study is expected to begin enrolling in June with a target of approximately 450 patients globally, including the United States, Canada and Europe.
In addition to REMDACTA, Genentech is close to completing enrollment of the global randomized, double-blind, placebo-controlled Phase III clinical trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra plus standard of care (SOC), versus placebo plus SOC in hospitalized adult patients with severe COVID-19 pneumonia. The first patient was randomized on April 3. In total, approximately 450 patients will be enrolled in COVACTA. This increase from the original target of 330 patients will allow for even more robust data, while minimally extending the recruitment period. Actemra is not currently approved for this use by the U.S. Food and Drug Administration (FDA). Genentech is committed to sharing data from the COVACTA study as soon as possible this summer. In addition, the protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals. Data from the REMDACTA trial are designed to supplement the COVACTA study.
The COVACTA study is conducted in collaboration with the FDA and the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). Genentech is also a participant in the Accelerated COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, led by the National Institutes of Health (NIH) and the Foundation of the NIH.
Genentech has also initiated a national Phase III double-blind, placebo-controlled randomized trial (EMPACTA, NCT04372186) that will focus on recruiting approximately 375 patients at trial sites known to provide critical care to underserved and minority populations that often do not have access to clinical trials.
Remdesivir has been issued an Emergency Use Authorization by the FDA for the treatment of hospitalized patients with severe COVID-19. Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. Remdesivir has not been approved by the FDA for any use. For information about the authorized use of remdesivir and mandatory requirements of the Emergency Use Authorization in the United States, please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorization available at www.gilead.com/remdesivir. – BioSpace