Biopharmaceutical company Regeneron on Wednesday reported that its monoclonal antibody cocktail treatment has helped mild and moderate covid-19 people.
The Phase 2 trial involved 452 patients, some of whom received treatment and some received a placebo, which does nothing. Only 1.6% of patients receiving treatment had sufficient progression of symptoms whether they were hospitalized or had to be cared for in an emergency room. The number of patients who received a placebo was 6.3%.
For the high-risk category patients – who were 65 years of age or older or obese – 4% of those who received treatment were hospitalized. For those who got a placebo, it was 15%. Those who received treatment also had slightly less severe symptoms than those who received placebo.
This study was mainly done to check whether the virus was eradicated by therapy by day 11. 11. Most patients had cured or detected the virus by then. While hospital admissions data was a secondary endpoint, the study’s lead author, Dr. Peter. Peter Chen described the difference as “dramatic” and “meaningful.”
More research is needed in a large number of patients to determine if the treatment known as Bamlanivimab actually works, but scientists involved in the trial said the initial results were “encouraging.”
The devil will be in the details and in the ratio of cost / benefit with these very expensive drugs, said Dr. Ginny Marazo, director of the Department of Infectious Diseases at the University of Alabama at the Birmingham School of Medicine. Said an email. Marazzo did not work on the trial.
To test the therapy in long-term care facilities, a large trial of green with mild to moderate covid-19 patients is still ongoing. The second trial is testing a monoclonal antibody in combination with another monoclonal antibody. That trial is also in patients with mild to moderate disease.
Regeneration results
As for Regeneron’s antibody therapy, the company said the results of its later-stage trials showed it reduced the need for medical visits in mild to moderate Covid-19 patients.
Regeneron said the treatment has greatly reduced the viral load and reduced the patient’s need to travel to a hospital, emergency room, emergency care or doctor’s office.
About 800 patients were involved in the analysis. Treatment patients had an average 10-fold reduction in viral load over 5 days compared to those taking placebo, which did nothing. Patients with a higher viral load at baseline benefited greatly from the treatment. The therapy resulted in a 72% reduction in Covid-19-related medical visits in patients with a risk factor for serious disease, the company said.
“Today’s analysis, involving more than 500 additional patients, potentially confirms that REGN-COV2 can actually significantly reduce viral load and further shows that this viral reduction is associated with a significant reduction in the need for further medical assistance,” Dr. George said. D. Yankopolos, president and chief scientific officer of Regeneran, said in a statement. “We continue to see strong effects in patients who are most at risk for a weak outcome due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors.
The results did not show any significant difference between the high and low doses of the treatment and is therefore reviewing the dosage of Regeneron that will be used in the ongoing outpatient trial, as there is a limited supply of treatments.
Regeneron said he shared the results with the FDA as part of a paper he submitted in his request for authorization of emergency use. The company said it would also submit these results for publication.
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