COVID Pill Shows Rapid Clearance Of Infection: Japanese Pharma Firm
A COVID pill by Japan's pharmaceutical firm Shionogi & Co Ltd has shown rapid clearance of the viral infection, the company said.
New Delhi: A COVID pill by Japan’s pharmaceutical firm Shionogi & Co Ltd has shown rapid clearance of the viral infection, the company said. The COVID pill, S-217622, “demonstrated rapid clearance of the infectious SARS-CoV-2 virus in Phase-2b results from the Phase II/III clinical trial” of the drug, Shionogi said in a statement.
“There was no significant difference in total score of 12 COVID-19 symptoms between treatment arms, however, S-217622 showed improvement in composite score of five ‘respiratory and feverish symptoms (post-hoc analysis)’,” Shionogi said.
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Both the Phase 1 and 2a/b parts of the Phase 2/3 clinical trials showed that S-217622 was well-tolerated, with few discontinuations due to drug, and no reports of serious adverse events or death. Treatment-emergent adverse events in these trials were generally mild to moderate, and resolved without treatment.
The Phase 2b study was conducted with 428 patients in Japan and South Korea. Its main purpose was to confirm the antiviral effect and clinical symptom improvement of S-217622 when orally administered once daily for five days, versus placebo.
“These results demonstrate that S-217622 rapidly eliminates SARS-CoV-2 in patients versus placebo, marking its potential, if approved, as an effective treatment option for COVID-19. As infections continue to rise in areas worldwide, it is important we have access to a range of easily administered treatment options to ease the pressures on our healthcare systems,” Isao Teshirogi, Ph.D., president and CEO at Shionogi & Co., Ltd said. “We look forward to continued study of this antiviral in Phase 3 trials.”
About COVID pill S-217622
S-217622, a therapeutic drug for COVID-19, is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus. S-217622 suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease, the company had said in its statement.
Shionogi has already been submitting the non-clinical, manufacturing/CMC data, and clinical trial data obtained so far to the PMDA. Currently, the Phase 3 part of a Phase 2/3 clinical trial in patients with mild/moderate symptoms and the Phase 2b/3 part in patients with asymptomatic/only mild symptoms are in progress.
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