Sanofi and Regeneron Begin Initial Covid-19 Treatment Trials

(Bloomberg) --

Sanofi and Regeneron Pharmaceuticals Inc. will soon begin evaluating an experimental treatment in patients hospitalized with severe Covid-19, the drugmakers said Monday.

The companies initiated a later-stage clinical trial in up to 400 patients for Kevzara, a fully-human monoclonal antibody that inhibits the so-called interleukin-6 (IL-6) pathway. Kevzara is already approved to treat adults with rheumatoid arthritis.

The announcement was made as global confirmed cases of Covid-19, the disease caused by the novel coronavirus, surpassed 165,000 worldwide,and deaths topped 6,400. No drugs or vaccines have yet been approved for the novel coronavirus and related lung illness.

Regeneron, which will be leading U.S.-based trials, will immediately begin enrolling patients across 16 sites, beginning with medical centers in New York, one of the epicenters of the domestic outbreak. Sanofi will lead upcoming trials in coming weeks outside of the U.S., including in countries hardest hit by the outbreak, such as Italy.

Shares of Sanofi fell about 7% in Paris, while Regeneron declined 3.1% in trading in New York before a broader sell-off triggered a market-wide trading halt.

The pathway the experimental treatment is targeting may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with Covid-19, the drugmakers said in a statement.

France’s Sanofi and Regeneron, based in Tarrytown, New York, will first evaluate how Kevzara impacts patients’ fevers and need for supplemental oxygen. The drugmakers will also assess the improvement in longer-term outcomes including preventing death and reducing the need for mechanical ventilation, supplemental oxygen and hospitalization.

In order to quickly initiate the clinical trial for patients severely impacted by the novel coronavirus, the drugmakers worked closely with the U.S. Food and Drug Administration and the Biomedical Advanced Research and Development Authority, said Regeneron Co-Founder and President George D. Yancopoulos.

In an initial, non-peer reviewed Chinese trial of 21 patients, scientists identified preliminary evidence that IL-6 may play an important role in driving the inflammatory immune response that causes acute respiratory distress in patients critically ill from Covid-19. Sanofi and Regeneron have launched the first controlled trial in the U.S. to evaluate the effect of IL-6 inhibition prospectively in such patients, according to Yancopoulos.

The drugmakers, which have long partnered on Kevzara, announced a new structure for their collaboration in late 2019. Sanofi, which had shifted its focus to oncology under new leadership, would hold rights to the drug outside of the U.S., while Regeneron would lead U.S.-based efforts.

In addition to Kevzara, the pharmaceutical companies are developing other experimental therapies in response to the coronavirus pandemic. Sanofi is investigating potential vaccine candidates, while Regeneron is working on an additional antibody for prevention and treatment of Covid-19.

Drug executives told U.S. President Donald Trump this month that antiviral medications could be available for patients in a matter of months. Vaccines, which would prevent healthy people from contracting the disease, are further from reaching doctors’ offices and pharmacy shelves.

To contact the reporter on this story: Riley Griffin in New York at rgriffin42@bloomberg.net

To contact the editor responsible for this story: Timothy Annett at tannett@bloomberg.net

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