BARDA throws weight behind Kevzara, Actemra studies as IL-6 inhibition gains momentum for late-stage COVID-19
HHS will fund trials of Regeneron’s Kevzara and Genentech’s Actemra to treat COVID-19. Both IL-6 inhibitors, which will be evaluated in patients with later-stage disease and respiratory deterioration, entered pivotal studies in the past week.
The agency said Saturday it would fund the Phase II/III study of Kevzara sarilumab, the start of which was announced March 16 by Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NASDAQ:SNY). The adaptive trial is to enroll up to 400 hospitalized patients with severe disease, who will receive best supportive care plus Kevzara or placebo.
The trial’s first part will evaluate Kevzara’s impact on fever and patients’ need for supplemental oxygen, the agency said. A larger second part will examine longer-term outcomes, including effects on mortality and the need for mechanical ventilation, supplemental oxygen, or hospitalization.
On Monday, Genentech said FDA has cleared the start of a 330-patient Phase III trial of Actemra tocilizumab in hospitalized patients with severe COVID-19 pneumonia, which HHS’s Biomedical Advanced Research and Development Authority (BARDA) is backing as well. Genentech, a unit of Roche (SIX:ROG; OTCQX:RHHBY), said March 19 that it would start the global, placebo-controlled trial, which is evaluating Actemra plus best supportive care.
Genentech said it would provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile as well.
According to ClinicalTrials.gov, the primary completion date is in December 2020 for the Actemra study, and in March 2021 for the Kevzara trial.
IL-6 inhibitors such as Kevzara and Actemra may ameliorate the immune response that leads to acute respiratory distress syndrome (ARDS) in patients with COVID-19. Anti-inflammatory could play a role in the treatment strategy for patients with advanced disease after respiratory function has begun to deteriorate. Evidence is emerging that antivirals are mainly effective earlier in the treatment paradigm (see “Slotting Anti-Inflammatories Into Treatment”).
Kevzara and Actemra are both approved to treat rheumatoid arthritis.
In Saturday’s announcement, HHS said BARDA’s funding for the Kevzara trial was “among the first” from H.R. 6074, the coronavirus appropriations legislation signed into law March 6.
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