Regeneron begins trials of COVID-19 antibody cocktail
Regeneron has said it has begun clinical trials of its antibody cocktail therapy for COVID-19, as pharma companies continue their search for treatments as the pandemic continues to cause havoc across the world.
With no end in sight to the global outbreak, the industry is pulling out all the stops to develop potential vaccines and therapies for the disease caused by the SARS-CoV-2 coronavirus.
Regeneron’s technology is based around anti-viral antibodies based on thousands produced by genetically modified mice with a “human” immune system, as well as antibodies isolated from humans who have recovered from COVID-19.
The company hopes the antibody could confer protection against infection as well as helping those with the disease to recover, and has told Reuters it could have enough data for approval by the end of summer.
Its scientists have selected the two most potent candidates and scaled up manufacturing with its in-house facility.
The antibodies bind to the part of the virus’s spike protein that binds with cells and allows them to infect them, an approach that diminishes the ability of mutant viruses to escape treatment.
Regeneron expects that the drug cocktail will have to be topped up as the antibodies will become depleted over time – but it could be an important weapon in a pharmaceutical arsenal against COVID-19 should it get approved.
The clinical programme will consist of four separate study populations: hospitalised COVID-19 patients, non-hospitalised symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure (such as healthcare workers or first responders) and uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate). The placebo-controlled trials will be conducted at multiple sites.
The first two adaptive phase 1/2/3 studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalised and non-hospitalised patients with COVID-19.
The phase 1 portion will focus on virologic and safety endpoints, and the phase 2 portion will focus on virologic and clinical endpoints.
Data from the phase 1 and phase 2 studies will be used to refine the endpoints and determine size for the phase 3 studies.