development of Korea-Japan, the efficacy of COVID-19 drugs

Japan's Shionogi Announces Phase III Clinical Results

Symptom improvement period, shorter than placebo

Capture the Shionogi homepage.

The difference in clinical design from Lagevrio and Paxlovid and the stop of the spread of COVID-19 are also variables.

 

The results of phase 3 clinical trials of Xocova, a candidate for oral COVID-19 treatment under joint development by Ildong Pharmaceutical with Shionogi, Japan, have been announced.

 

In the pharmaceutical industry, it is interpreted that it is one step closer to approval for emergency use in that it has produced meaningful results in shortening the period of symptom improvement, the primary evaluation variable.

 

Some predict that it is difficult to guarantee Emergency Use Authorization because there is a difference in clinical design from Emergency Use Authorized MSD's Lagevrio and Pfizer's Paxlovid, and there was no permission or approval from the U.S.

 

and Europe.

 

◆Xocova, similar mechanism to Paxlovid, clinical design is different Shionogi announced the results of phase 3 clinical trials of Xocova on its website on the 28th.

 

In a clinical trial of 1,821 mild and moderate patients in Korea, Japan, and Vietnam, patients who administered Xocova showed significantly lower time than those who administered placebo until the five major symptoms of COVID-19 (nose congestion, runny nose, sore throat, cough, and fever) subsided.

 

The time to suppress symptoms was 167.9 hours (about 7 days) in the group administered low dose Ensitrelvir and 192.2 hours (about 8 days) in the group administered placebo.

 

The results of examining how much viral RNA was reduced on the 4th day of administration also showed that the Ensitrelvir administration group decreased significantly compared to placebo.

 

Xocova is designed to block the activity of 3CL protease, a key enzyme needed when the COVID-19 virus (SARS-CoV-2) proliferates in cells.

 

The mechanism is similar to Xocova and Paxlovid, but there is a large difference in clinical design.

 

In the case of Paxlovid, the risk of hospitalization and death decreased by 89% as of the 28th day of administration.

 

As of the 29th day of administration, Lagevrio's risk of hospitalization and death decreased by 30%.

 

There is also a result that additional clinical trials conducted in India and other countries showed 65% effect.

 

Xocova is expected to be less burdened by taking drugs than Paxlovid and Lagevrio.

 

Paxlovid and Lagevrio have many drugs to take at once.

 

Paxlovid is taken twice a day for a total of 5 days as a set of Nirmatrelvir and Litonavir.

 

The total number of pills to be taken for five days is 30.

 

4 capsules of Lagevrio is taken twice a day for 5 days.

 

The total number of pills taken during the treatment period amounts to 40 capsules.

 

Xocova is taken once a day for a total of 5 days.

 

The number of pills to be taken per episode has not been clearly determined, but it is known that three tablets are taken on the first day and one tablet is taken every day since then.

 

If Xocova is approved EUA in Korea, it will be the third drug for oral COVID-19.

 

The Ministry of Food and Drug Safety conducted EUA on Paxlovid in December last year and Lagevrio in March this year.

 

In the case of Paxlovid, the EUA was decided five days after the request of the Korea Centers for Disease Control and Prevention (December 22, 2021).

 

It is only 48 days, including the period of preliminary review by the Ministry of Food and Drug Safety.

 

Lagevrio took a total of 127 days from the request of the Korea Centers for Disease Control and Prevention (November 17, 2021) to the EUA decision of the Ministry of Food and Drug Safety.

 

Considering the previous cases, Xocova is also expected to take two to four months to make the EUA decision.

 

However, the pharmaceutical industry's prospects are mixed as to whether the Ministry of Food and Drug Safety will finally decide Xocova's EUA.

 

A pharmaceutical industry official said, "When Japan withheld its judgment on EUA in July, we agreed to wait for phase 3 results to see more accurate data and make a final decision," adding, "We confirmed the effect of improving symptoms through large-scale clinical trials, so the possibility of EUA in Japan has increased.

 

If the EUA is decided in Japan, it will also help the EUA in Korea, he predicted.

 

Some predict that the EUA will be difficult considering the domestic COVID-19 epidemic.

 

Paxlovid & Lagevrio

Shionogi applied for Xocova's conditional permission to the Japanese Ministry of Health, Labor and Welfare in February this year.

 

Since then, the EUA application bill in Japan has been passed, and in June and July, the Ministry of Health, Labor and Welfare and Food Sanitation Council discussed whether to do so.

 

The Pharmaceutical Affairs Council mainly said, "It is effective in reducing the amount of the virus, but there is not enough data to improve clinical symptoms." In Korea, Ildong Pharmaceutical plans to launch EUA regardless of Shionogi.

 

In August, domestic clinical trials were completed.

 

Ildong Pharmaceutical plans to apply for EUA in Korea by submitting the results of phase 3 clinical trials in Japan along with domestic clinical results.