The U.S. Department of Human Health and Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) is to bolster the campaign to develop an effective therapy to address the COVID-19 pandemic. The ASPR-affiliated Biomedical Advanced Research and Development Authority (BARDA) are to support the trial of a drug currently approved for the treatment of rheumatoid arthritis, Kevzara®, for the treatment of patients with severe coronavirus infections. The trial is in partnership with Regeneron Pharmaceuticals, Tarrytown, New York, USA.
Increased risk of life-threatening respiratory failure is a clinical feature of patients with COVID-19, thought to be in part regulated by elevated abundancies of proinflammatory molecules such as IL-6. Kevzara is a fully-human monoclonal antibody that acts through binding the IL-6 receptor on normal cells to inhibit the inflammatory response characteristic of rheumatoid arthritis, and is therefore a candidate for eliciting a similarly targeted response in COVID-19 patients and to translate into better clinical outcomes.
“We are working at a record pace with our private sector partners to speed development of therapeutic treatments for people with COVID-19,” commented BARDA Director Rick A. Bright. “By repurposing a currently approved product, we may be able to expedite development and make treatments available quickly.”
The trial will determine if Kevzara can be used safely and effectively to reduce the amount of time that a person infected with the novel coronavirus remains ill, and will be divided into two parts: 1) evaluation of the impact Kevzara has on a patient’s fever and their need for supplemental oxygen; and 2) evaluation of any improvement in longer-term outcomes, including overall survival and reduction in any need for routine mechanical ventilation, supplemental oxygen, and/or hospitalisation.
This collaboration is among the first issued by BARDA to receive funding from the H.R.6074 – Coronavirus Preparedness and Response Supplemental Appropriations Act passed by the U.S. Congress on March 6th, 2020. HSS Secretary Alex Azar lamented the efforts: “The close collaboration between BARDA, the FDA, and Regeneron to initiate this trial as soon as possible again demonstrates the speed at which we are responding to this pandemic.”