Trial of arthritis drug to treat coronavirus stopped short after it failed to help severely-ill patients on ventilators and left some with dysfunctioning organs and high blood pressure
- Regeneron and Sanofi announced Thursday that they are stopping a 194-patient trial for the arthritis drug, Kevzara
- 80% of patients given the drug developed side effects
- Four percent had high blood pressure and six percent developed multi-organ dysfunction syndrome
- Shares of Regeneron fell three percent in after-hours trading following the companies' announcement
Regeneron Pharmaceuticals Inc and Sanofi said on Thursday their rheumatoid arthritis drug Kevzara failed to meet the main goals of a US study testing it in the most critically ill COVID-19 patients.
Previous trial results had shown that the drug did not help patients with less severe COVID-19, the disease caused by the novel coronavirus, and shares of Regeneron fell about 3 percent in after hours trading.
Kevzara belongs to a class of drugs called interleukin-6 inhibitors that are being tried to help regulate a dangerous overreaction to the virus by the body's immune system called 'cytokine storm.'
Critically ill coronavirus patients given the drug fared marginally better than those who got a placebo, but the benefit was not statistically significant, Regeneron said in a Thursday press release.
What's more, patients on Kevzara also suffered more side effects, including serious ones like altered function of multiple organs. The trial was stopped short as a result.
Regeneron and Sanofi announced Thursday that their arthritis drug Kevzara failed to improve survival odds for coronavirus patients and may have increased their risks for problems like multi-organ dysfunction and high blood pressure. The trial was stopped short
All 194 people recruited to the trial were already severely ill and on mechanical ventilators when they joined.
Eighty percent of the trial patients who got Kevzara experienced adverse events, compared to 77 percent of patients who received a placebo.
Serious adverse events were more common in the Kevzara group as well.
Six percent developed multi-organ dysfunction syndrome - a condition in which more than one organ starts behaving abnormally, which may be reversible, but can become life-threatening - compared to five percent in the placebo group.
High blood pressure was seen in four percent of the Kevzara-treated patients, compared to three percent of those on a placebo.
Other drugs in the same class, including Roche Holding AG's Actemra, are also being studied as treatments for COVID-19.
Acterma has shown more promise on small study's so far.
A separate Sanofi-led trial of Kevzara outside of the United States in hospitalized patients with severe and critical COVID-19 using a different dosing regimen is ongoing, the companies said.
Shares of Regeneron fell three percent in after-hours trading following the announcement of the trial failure. It comes after months of steadily climbing share-prices for the company
Patients who required mechanical ventilation or high-flow oxygen therapy or treatment in an intensive care unit were considered critically ill.
Those who required oxygen without mechanical or high-flow oxygenation were considered severely ill.
More than three dozen US states were seeing a rise in COVID-19 cases, according to a Reuters analysis on Thursday, the latest grim sign that the coronavirus pandemic, once thought to be waning, was again spreading rapidly.
Worldwide, the virus has infected 10.76 million people, resulting in 516,600 deaths.
Shares of Regeneron were down $17.20 at $605.25 after hours.
They are up about 67 percent so far this year, driven in part by hopes that the one of the company's drugs would help ease coronavirus's potentially life threatening symptoms.
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