PARIS, France — Sanofi Pasteur, the French pharmaceutical giant, said Tuesday that international Phase 3 clinical tests of its Kevzara drug for serious coronavirus disease-2019 (COVID-19) cases had proved inconclusive and it was halting the trial.
The Phase 3 test— normally the last before official approval for use— “did not meet the primary or secondary evaluation criteria compared with a placebo, and in both cases, compared with established hospital care,” it said in a statement.
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Phase 3 trials typically involve large populations using the drug or vaccine under study to test the product’s efficacy and safety.
Sanofi said neither the company nor its American partner in developing the drug, Regeneron, “envisage further clinical tests of Kevzara for the treatment of COVID-19.”
Although Kevzara “did not give us the results we were hoping for, we are proud of the work done by our team,” Dr. John Reed, Sanofi research head, said in the statement.
Since the outbreak of the coronavirus pandemic late last year in China, the deadly virus has claimed more than 800,000 lives and caused huge economic damage, sparking a global race to find a vaccine and effective treatments.
In the Philippines, COVID-19 cases have surged to 220,819, the largest in Southeast Asia, including 3,558 deaths as of Sunday afternoon.
Sanofi is one of many companies developing a vaccine but scientists are cautious in saying that at best, one may only be available by the end of this year for initial use. The Philippines is looking to become one of the first takers of a COVID-19 vaccine, allotting P2.5 billion for the purchase of still unavailable immunization next year.
Manila is also participating in third phase trials of another potential COVID-19 vaccine, that of Russia’s Sputnik V, which was already registered even in the absence of clear efficacy and safety study on a large population. — with Philstar.com