Regeneron Pharmaceuticals said Thursday that the first placebo-controlled study investigating its dual antibody cocktail, dubbed REGN-COV2, for the prevention and treatment of COVID-19 has started. According to the company, REGN-COV2 combines the REGN10933 and REGN10987 neutralising antibodies, which bind non-competitively to the receptor binding domain of the SARS-CoV-2 virus' spike protein.
Chief scientific officer George Yancopoulos suggested that besides potentially preventing and treating infection, REGN-COV2 may also be able to "preempt viral 'escape,' a critical precaution in the midst of an ongoing global pandemic." He added that the antibody cocktail approach could have "long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines."
Regeneron said that the clinical programme will consist of four separate study populations, with the first two adaptive Phase I/II/III trials evaluating the dual antibody cocktail as a treatment for hospitalised and non-hospitalised patients with COVID-19, who will be given a single intravenous infusion of REGN-COV2. Other populations to be studied include uninfected people who are at high-risk of exposure or who have close exposure to a COVID-19 patient, with these uninfected participants given smaller subcutaneous doses.
Key data by end of summer
"If it goes perfectly well, within a week or two we will move to the second phase," Yancopoulos said, adding that "within a month or so of that we will have clear data that this is or isn't working. By the end of summer, we could have sufficient data for broad utilisation."
The executive indicated that "REGN-COV2 could have a major impact on public health by slowing spread of the virus…and could be available much sooner than a vaccine." Meanwhile, he said Regeneron has cleared the way for production of the antibody compound at its New York manufacturing facility. In March, Regeneron said it aimed to have hundreds of thousands of doses ready for clinical testing in late summer.
Earlier this week, AstraZeneca said it planned to advance a combination of two monoclonal antibodies that bind to distinct parts of the SARS-CoV-2 spike protein into clinical testing within the next two months, while dosing has been initiated in Phase I studies of Eli Lilly's neutralising antibodies LY-CoV555 and JS016, with the latter partnered with Junshi Biosciences.
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