Following a clinical trial, Japanese drugmaker Shionogi & Co. Ltd. has announced its experimental new pill has “demonstrated rapid clearance” of the virus that causes COVID-19.
Citing new data from the trial, the company claims S-217622 “demonstrated rapid clearance of the infectious SARS-CoV-2 virus,” Shionogi said in a statement Sunday.
“The Phase 2b study was conducted with 428 patients in Japan and South Korea,” Shionogi says. “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.”
In addition to rapid clearance, the findings showed “there was no significant difference in the total score of 12 COVID-19 symptoms between treatment arms, however, S-2176622 showed improvement in a composite score of five ‘respiratory and feverish’ symptoms.”
According to Shionogi, clinical trials showed the pill “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,” according to the statement.
“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,” said Isao Teshirogi, Ph.D., President and CEO at Shionogi & Co., Ltd. “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.”
“We look forward to continued study of this antiviral in Phase 3 trials,” Teshirogi said.
In March, Shionogi stated it would launch a global trial for the antiviral, with U.S. government support, and Teshirogi has stated production could be as high as 10 million doses per year, according to Fox Business.
Shionogi shares were up Friday, following reports the U.S. government is in talks with the company to purchase supplies of the drug.
It’s a welcome turn of events for the drugmaker after it watched its stocks tumble by as much as 16% on April 13 on reports that preclinical data suggested the drug could pose risks to pregnancies.
In an April 13 statement, Shionogi confirmed that “fetal skeletal morphological abnormalities” were observed in a non-clinical safety study of S-217622.
“This non-clinical study was conducted as one of the regulatory safety studies required in drug development,” Shionogi said. “These observations were made at doses higher than the clinical dose, exceeding the expected human blood concentration and administration period.”
“Pregnant, lactating, and potentially pregnant women are typically excluded from clinical trials and this has been the case for S-217622,” Shionogi stated, adding that “results from this non-clinical study were promptly reported to the medical institutions conducting the clinical trial, and clinical subjects were informed of risk-related information, including this result, and then participated in the clinical trial after their informed consent.”
“The clinical implications of this non-clinical finding will be comprehensively judged in the ongoing approval review by the PMDA, and the contents of the package insert will be decided through that process,” said Shionogi.
Going forward, the company says, “A separate global Phase 3 study of S-217622 is underway aiming to recruit participants globally to support regulatory filings this year.”
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