Japanese drugmaker’s COVID-19 pill ready to move to final trial phase
Bloomberg February 7, 2022
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Japanese drugmaker Shionogi said its antiviral pill for COVID-19 is ready to move to the third and final stage of development.
"We expect it to be an effective treatment," CEO Isao Teshirogi said in a briefing in Tokyo on Monday on the state of clinical trials that are generally required to seek approval.
Shionogi plans to begin a phase 3 global trial this month, following the completion of phase 2b on Tuesday, the company said in a statement. The drugmaker is also in discussions with the regulators in the U.S. and Europe, and is seeking a partner to commercialize the pill globally.
The viral load reduction for Shionogi's treatment, called S-217622, is similar to Pfizer's rival pill Paxlovid, which was a surprise, Akash Tewari, an equities analyst at Jefferies, wrote in a note to clients. Shionogi's stock jumped 10% after it released the data, the biggest gain in more than 18 months.
Data from the 2b phase of the trial will be ready to be submitted within a couple of weeks, Teshirogi said.
Patients who received a high dose of the experimental drug were 80% less likely to be shedding infectious virus four days later than those given a placebo, while a lower dose cut the risk by 63%, the company said in earnings presentation documents on Jan. 31.
In Japan, Shionogi is preparing to make the pill for 1 million people by the end of March, and plans to eventually produce it for 10 million people every year.
Shionogi is behind schedule in developing the pill after it struggled to find patients to enroll in clinical trials in Japan. The company submitted data from an earlier trial to the regulators in January and has begun talks on how it will submit data from later trials.