COVID-19：电晕药物“S-217622”临床试验结果：盐野木制药
-病毒持有者减少了60-80%-
盐野木：
目前正在开发的COVID-19，S-217622，一种用于轻症患者的药物。
1月31日 关于终期临床试验
首次公布实际给予患者的数据。
口服药物 S-217622 的给药结果：
接受口服药物 S-217622 的患者
与安慰剂患者相比，
体内的病毒载量迅速下降。
传染性病毒检出率：
检测到传染性病毒的人的百分比是
服用 3 剂后（开始饮用后的第 4 天），
据说它比接受安慰剂的人减少了 60% 到 80%。
Shionogi的数据评估：
Shionogi解释说，“我们能够确认它对人类的有效性。”
它已经提交给药品和医疗器械局（PMDA）。
“我想以早期批准申请为目标”
终期临床试验方法：
Shionogi 于去年 9 月底开始了临床试验的最后阶段。
为69名日本新冠患者
高剂量和低剂量组药物，
分成3组给予安慰剂，
检查了当每天一次给药持续5天时的抗病毒效果。
终期临床试验-上半年：
据报道，在服用3剂后，大约70%的安慰剂组检测到了传染性病毒。
在给予口服药物的组中，它下降到约10％至20％。
5剂后：
安慰剂组约 30% 和口服药物组 0% 至 10% 检测到传染性病毒。
还公布了Omicron应变的作用：
这些数据大部分来自三角洲疫情。
“也证实了对Omicron菌株的影响的数据”还发布了。
最后阶段临床试验-下半年：
末期临床试验下半年
面向国内外近2000名患者
与安慰剂组相比，验证了直到症状改善的时期。
Shionogi的药物：
无论恶化的风险如何，预计它都会被广泛使用。
每日新闻
https://mainichi.jp/articles/20220131/k00/00m/040/198000c
Shionogi Presents Clinical Trial Results of the COVID-19 Therapeutic Drug S-217622
January, 31, 2022
Shionogi announced that
Shionogi presented the results up to day 6 of the Phase 2a part of a Phase 2/3 clinical trial of S-217622,
an orally administered antiviral drug for COVID-19, in its third quarter financial results1.
During the presentation, the antiviral and safety results from the Phase 2a part were announced.
This study
is a randomized, placebo-controlled, double-blind study in Japanese adults,in which the antiviral effects and safety of this drug given orally once daily for 5 days were evaluated.
The information presented is outlined below.
・ A rapid virus reduction effect was confirmed in the S-217622 group compared to placebo.
・ A rapid decrease in proportion of patients with viral titer positively in the S-217622 group compared to placebo.
・ No high-grade or serious adverse events were observed and tolerability was observed in this trial.
As expressed in the related notifications2, 3,
Shionogi has already been submitting these clinical data to the Pharmaceuticals and Medical Devices Agency (PMDA).
Shionogi will continue to submit clinical trial data sequentially, as it is obtained.
We will continue to consult closely with the Ministry of Health, Labor and Welfare, PMDA and other organizations regarding future aspects of the submission process and timing.
About 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 Phase 2b/3 part of a Phase 2/3 clinical trial is currently underway in mild, moderate, or asymptomatic COVID-19 patients4, 5.
Shionogi & Co., Ltd. OSAKA, Japan,
https://www.shionogi.com/global/en/news/2022/01/20220131_2.html