COVID-19: Corona drug’S-217622′ clinical trial result: Shionogi Pharmaceutical
-Virus holders decreased by 60-80%-
Shionogi:
COVID-19 currently under development, S-217622, a drug for mildly ill patients.
January 31 About the final stage clinical trial
The data actually administered to the patient was published for the first time.
Results of administration of oral medicine S-217622:
Patients who received the oral drug S-217622
Compared to placebo patients,
The viral load decreased quickly in the body.
Infectious virus detection rate:
The percentage of people who have detected an infectious virus is
After 3 doses (4th day after starting to drink),
It is said that it was 60 to 80% less than those who received the placebo.
Data evaluation by Shionogi:
Shionogi explained, “We were able to confirm its effectiveness for humans.”
It has already been submitted to the Pharmaceuticals and Medical Devices Agency (PMDA).
“I want to aim for early approval application”
Final stage clinical trial method:
Shionogi has started the final stage of clinical trials since the end of September last year.
For 69 new Japanese corona patients
High-dose and low-dose groups of drugs,
Divide into 3 groups to administer placebo,
The antiviral effect when administered once a day for 5 days was examined.
Final Phase Clinical Trials-First Half:
According to the report, infectious virus was detected in about 70% of the placebo group after 3 doses.
It decreased to about 10 to 20% in the group to which the oral medicine was administered.
After 5 doses:
Infectious viruses were detected in about 30% of the placebo group and 0 to 10% of the oral drug group.
Also announced the effect of Omicron strain:
Most of this data comes from the Delta epidemic.
“Data that the effect on Omicron strain was also confirmed” was also released.
Final stage clinical trial-second half:
The second half of the final stage clinical trial
Targeting approximately 2000 patients at home and abroad
Compared with the placebo group, the period until symptom improvement is verified.
Shionogi’s medicine:
It is expected to be widely administered regardless of the risk of aggravation.
Mainichi Shimbun
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