On the day when the first doses of monoclonal antibodies arrive in some regions, new data emerge on a cocktail not yet approved but in the testing phase, casirivimab and imdevimab. The data comes from the companies that are studying them, Regeneron in partnership with Roche, and concerns two studies. The first, phase III, involved administering the drugs to non-hospitalized high-risk patients with COVID-19 whose symptoms began for less than 7 days and showed that the cocktail reduced the risk of hospitalization or death of the 70% compared to placebo. The second showed that the drugs have the ability to reduce the duration of symptoms from 14 to 10 days (median numbers). In addition, a complementary phase II study in symptomatic or asymptomatic low-risk outpatient patients with COVID-19 showed significant and comparable viral load reductions at doses between 300 and 2,400 mg.
The detailed results – the companies know – will be shared with regulatory authorities and reviewed as soon as possible. Regeneron will share new data with the US Food and Drug Administration (FDA) and Roche and Regeneron will continue to work with the European Medicines Agency (EMA) and other health authorities around the world. At the end of February, the European Agency’s Committee for Medicinal Products for Human Use had already issued a scientific opinion supporting the use of casirivimab and imdevimab as a treatment option for patients with Covid-19 without the need for oxygen.
Other trials are also underway: a Phase II / III clinical trial for the treatment of COVID-19 in hospitalized patients in the UK and a Phase III trial for the prevention of the disease in family contacts of patients. To date, more than 25,000 people have participated in clinical studies on casirivimab and imdevimab and the safety profile – the pharmaceuticals always report – continues to remain constant.
The two neutralizing antibodies casirivimab and imdevimab were designed to bind uncompetitively to the critical receptor binding domain of the virus spike protein. This is believed to decrease the ability of mutated viruses to escape treatment and protect against spike protein variants, which may emerge in the population.
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