Seeking a shortcut to treatment for the novel coronavirus pandemic, Sanofi and Regeneron spied promising results in severe patients with their shared arthritis med Kevzara. Now, they're hustling the med into immediate clinical trials to put that promise to the test.
Sanofi and Regeneron are ready to enroll a phase 2/3 clinical program studying arthritis med Kevzara as a therapy for patients hospitalized with severe COVID-19, Sanofi said Monday.
In a two-part U.S. arm of the Kevzara program, the drugmakers will evaluate the drug as an add-on to supportive care in around 400 patients across 16 states. The first segment of the trial will study Kevzara's impact on fever and patients’ need for supplemental oxygen while a second segment will focus on longer-term outcomes, including preventing death and cutting the need for supportive care such as mechanical ventilation, supplemental oxygen and/or hospitalization, the partners said.
Sanofi also isn't stopping at a therapeutic alone. As FiercePharma has reported, it's "leveraging previous development" of a vaccine for SARS to help unlock a possible COVID-19 vaccine as well, John Reed, Sanofi's global R&D head, said in a release. It's working on the shot in partnership with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority unit.
Sanofi and Regeneron's effort to repurpose Kevzara in the COVID-19 response has drawn the praise of market watchers, including Evercore ISI analyst Josh Schimmer, who last week called Regeneron's strategy, in particular, a "national strategic asset."
Kevzara, approved in 2017, might hold promise in helping patients’ immune systems stop attacking healthy cells, Sanofi’s global head of development for immunology and inflammation Naimish Patel told The Wall Street Journal. The move comes after a rival drug, Roche’s Actemra, notched a recommendation from China’s National Health Commission for patients with serious lung damage earlier this month.
Roche’s Genentech is weighing studies of the drug in COVID-19 patients, a spokesperson told the WSJ.
Kevzara has already posted two "encouraging case reports" in COVID-19 patients in Italy, Schimmer wrote in a note to investors last week. Clinical trials may lead to an approved indication in severe patients that could eventually expand to a larger approval in acute respiratory distress syndrome, Schimmer wrote.
A possible head start on a COVID-19 therapeutic could go a long way toward soothing investor worries after an Evercore survey released Monday revealed a general fear of U.S. cases reaching a peak in the coming months. In its survey, most investors said they expected a "large" or "very large" impact on U.S. gross domestic product from the pandemic with respondents forecasting up to 50,000 new cases reported in the coming month, Evercore said.