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Covid-19 antibody therapy shows encouraging results in separate trials



Also on Wednesday, biopharmaceutical company Regeneron reported that its monoclonal antibody cocktail therapy can help people with mild and moderate Covid-19.

In laboratories around the world, there are at least 78 Covid-19 monoclonal antibody treatments at different stages of development, but the monoclonal antibody treatments produced by Eli Lilly and Regeneron have received the closest attention. Both Lilly and Regeneron have applied to the U.S. Food and Drug Administration (FDA) for emergency use authorization, which will open up their antibody treatments to more people using Covid-19.
Eli Lilly’s results were published in the New England Journal of Medicine on Wednesday. The company̵
7;s interim analysis showed that its monoclonal antibody treatment appears to reduce the risk of hospitalization for a small number of patients (mild to moderate Covid-19 cases) and relieve some symptoms.

The phase 2 trial involved 452 patients, some of whom received treatment and some received a placebo, but no effect. Only 1.6% of the treated patients developed enough symptoms to be admitted to the hospital or emergency room. For patients receiving a placebo, this ratio was 6.3%.

For patients in the high-risk category-65 years of age or older or obese-4% of patients received treatment. For those who took a placebo, it was 15%. Compared with patients receiving placebo, patients receiving treatment also had milder symptoms.

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The main purpose of the study was to test whether the therapy eliminated the virus on the 11th day. By then, the vast majority of patients have eliminated or almost no such virus. Although hospitalization data is a secondary endpoint, study co-author Dr. Peter Chen described the difference as “dramatic” and “significant.”

More studies are needed on more patients to determine whether this therapy, called bamlanivimab, is really effective, but scientists who were not involved in the trial said these early results are encouraging.

Dr. Jeanne Marazzo, head of the Department of Infectious Diseases at the University of Alabama Medical School of Medicine at Birmingham, said: “The devil will be the details, and of course the cost/benefit ratio of these very expensive drugs.” The email said. Marrazzo did not participate in the trial.

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On Wednesday, Eli Lilly and Company announced that it has reached a $375 million deal with the government to purchase 300,000 bottles of antibody therapeutics, subject to emergency use authorization from the US Food and Drug Administration, and will be delivered in two months. Eli Lilly applied for emergency use authorization in October. The company said it plans to provide 100,000 doses within a few days of approval and will produce one million doses by the end of 2020. The treatment will be provided to patients free of charge.
On Monday, Eli Lilly announced the termination of another trial of its antibody therapy. As the results showed that the treatment did not help patients with severe symptoms, the trial on hospitalized patients was stopped.

Eli Lilly’s large-scale trial for patients with mild to moderate Covid-19 is still ongoing, and trials of this therapy in long-term trial facilities are also ongoing. Another experiment is testing the monoclonal antibody in combination with another monoclonal antibody. The test is also suitable for patients with mild to moderate disease.

Regeneron results

Regarding Regeneron’s antibody therapy, the company said that the results of its late-stage trials show that it reduces medical visits for patients with mild to moderate Covid-19.

The company announced the news in a press release on Wednesday. The details of the data have not been published in medical journals and have not been peer reviewed.

Regeneron said that this treatment method greatly reduces the viral load and reduces the need for patients to go to the hospital, emergency room, emergency room or doctor’s office.

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The analysis involved nearly 800 patients. Compared with patients taking a placebo, the average viral load of the treated patients on the 5th day was reduced by more than 10 times on average, while the placebo was helpless. Patients with a higher viral load at baseline may benefit more from treatment. The company said that this therapy has reduced the number of Covid-19-related medical visits for patients with a risk factor for serious illness by 72%.

Dr. George D said: “Today’s analysis involves more than 500 additional patients and prospectively confirms that REGN-COV2 can indeed significantly reduce viral load, and further shows that the reduction of these viruses is related to a significant reduction in further medical needs. Yancopoulos, President and Chief Scientific Officer of Regeneron, said in a statement. “We continue to see that due to high viral load, ineffective antibody immune responses at baseline or pre-existing risk factors, the effect is the strongest among patients most likely to lead to a poor prognosis.”

The results did not show any significant difference between high and low doses, and due to the limited supply of regenerative therapy, Regeneron is reviewing the dose it will use in ongoing outpatient trials.

Regeneron said it has shared its results with the FDA as part of the documents submitted in its emergency use authorization request. The company said it will also submit these results for publication.

In July, Regeneron reached a $450 million deal with the government. Once approved, the government will provide Americans with free therapeutic or preventive doses. The company began to expand the production of antibody treatments in the spring.

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