Initial Treatment Trials for COVID-19 by Sanofi and Regeneron
On 16 March 2020, Sanofi and Regeneron Pharmaceuticals Inc. stated that they will soon start examining an experimental treatment in patients admitted in hospitals with extreme COVID-19 infection.
The companies launched a later-stage clinical trial in almost 400 individuals for Kevzara, a fully-human monoclonal antibody that prevents the interleukin-6 (IL-6) pathway. However, Kevzara is already authorized to treat rheumatoid arthritis in adults.
The revelation was made as COVID-19 positive cases caused by the novel coronavirus exceeded 165,000 internationally, and fatalities reached 6,400. No drugs or vaccines have yet been authorized for COVID-19 treatment and relevant lung health problems.
Regeneron, which will be leading U.S.-based initial treatment trials, will immediately start enrolling patients across 16 sites, starting with medical centers in New York, which is one of the epicenters of the domestic COVID-19 outbreak. Sanofi will lead upcoming trials in the coming weeks outside of the U.S., including in countries like Italy, which is hit hard by this outbreak.
Before a broader sell-off triggered a market-wide trading halt, shares of Regeneron in New York and shares of Sanofi in Paris declined by 3.1% and 7% respectively.
The drug manufacturers said the pathway of the trial treatment may contribute to driving the overactive inflammatory response in the lungs of individuals who are severely or critically sick with COVID-19 infection.
Regeneron and France’s Sanofi based in Tarrytown, New York, will first evaluate how Kevzara impacts the patient’s fever and the need for oxygen supplement. The drugmakers will also evaluate the improvement in longer-term outcomes including preventing fatality as well as lowering the need for artificial ventilation, supplemental oxygen, and hospital stay.
George D. Yancopoulos, Co-Founder and President, Regeneron said, “The drug manufacture worked with the U.S. FDA and the Biomedical Advanced Research and Development Authority to swiftly start the clinical test for individuals who are badly affected by the coronavirus COVID-19.
Yancopoulos also added, Scientists identified a shred of preliminary evidence in a first, non-peer reviewed Chinese trial of 21 patients, that IL-6 might play an important function in inducing the inflammatory immune response that causes intense respiratory system distress in the individuals critically ill from COVID-19. Sanofi, as well as Regeneron, have launched the initial controlled trial in the UNITED STATES to determine the inhibition effect of IL-6 respectively in such individuals.
The drug manufacturers who have actually long partnered on Kevzara announced a new structure for their collaboration in late 2019. Regeneron would lead U.S.-based initiatives, while Sanofi, which had actually changed its emphasis to oncology under new management would certainly hold legal rights to the medicine outside of the U.S.
The pharmaceutical industries are developing other experimental treatments to fight against the coronavirus pandemic, in addition to Kevzara. Regeneron is focusing on an additional antibody for preventing and treating COVID-19 and Sanofi is experimenting om potential vaccine against COVID-19.
This month, the drug executives informed U.S. President Donald Trump that the antivirus medicines could be available for patients in a few months. But the vaccines, which would help to prevent healthy people from getting infected are further from reaching doctors and pharmacies.
Author: Namitha Thampi
