In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|October 1, 2021
REGEN-COV Shows Promising Results in Hospitalized COVID-19 Patients
Author(s)BioPharm International Editors
Rengeron’s trial found that REGEN-COV significantly reduced viral load of patients with COVID-19.
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Regeneron announced that a trial assessing investigational REGEN-COV (casirivimab and imdevimab) in hospitalized COVID-19 patients met its primary endpoint on Sept. 30, 2021. Additionally, the company indicated that it noted improvements across all clinical endpoints.
REGEN-COV is an investigational medicine for the treatment of people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. It was granted emergency use authorization by FDA, but it is still in FDA’s review process for use in hospitals.
According to a company press release, REGEN-COV significantly reduced viral load in patients who entered the trial without having mounted their own antibody response (seronegative) and required low-flow or no supplemental oxygen. Patients who received REGEN-COV in this trial experienced a 36% reduced risk of dying within 29 days of receiving treatment, while those who were seronegative when they entered the trial had a 56% reduced risk.
Serious adverse events occurred in 21% of REGEN-COV patients (n=285) and 26% of placebo patients (n=174). While doses of both 2400 and 8000 mg were administered to patients, researchers did not notice any clinical difference between dosage groups.
“These data show that REGEN-COV can benefit certain patients even after they are hospitalized, reducing the amount of virus and clinical consequences,” said Eleftherios Mylonakis, primary investigator of the trialand professor of Medicine, Molecular Microbiology, and Immunology, and director of Infectious Disease at Brown University and the Lifespan hospitals, in the press release. “Taken together with results announced earlier this year from the
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