Japanese drugmaker Shionogi & Co. said Monday that it plans to start a global Phase 3 trial of its Covid-19 pill as soon as late February and is in discussions with U.S. and European regulators over the trial.
Shionogi said a Phase 2a trial showed that the virus was eliminated more quickly on average in a group of patients who took the pill compared with a group that took a placebo. The company didn't release data on whether the pill prevented complications of Covid-19 or deaths from the disease.
Currently, Shionogi is conducting what it calls a Phase 2b/3 trial in Japan and some other countries but not in the U.S. That trial is expected to end by late July this year, it said. Separately, it said it is talking to the Food and Drug Administration and the European Medicines Agency about a global Phase 3 trial that it targets to begin in late February.
Shionogi said it plans to manufacture enough pills for a million patients by March. It said it is still in discussions with global pharmaceutical companies about a partnership deal.
Pfizer Inc. is already marketing a Covid-19 pill called Paxlovid that has a similar mechanism to Shionogi's pill, which is code-named S-217622.
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