US biotech company Regeneron Pharmaceuticals has started the first clinical trial of its investigational dual antibody cocktail REGN-COV2 (REGN10933+REGN10987) for the prevention and treatment of COVID-19.
The REGN-COV2 clinical program will feature four separate study populations, which include hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure, and uninfected people with close exposure to a COVID-19 patient.
The placebo-controlled COVID-19 clinical trials will be carried out at various sites.
According to Regeneron Pharmaceuticals, the first two adaptive phase 1/2/3 studies will assess REGN-COV2 as a treatment for hospitalized and non-hospitalized patients with novel coronavirus. The phase 1 part will focus on virologic and safety endpoints, while the phase 2 part will focus on virologic and clinical endpoints.
The findings from the phase 1 and phase 2 studies will be used for refining the endpoints and determine the size for the phase 3 studies.
Regeneron Pharmaceuticals said that its scientists examined thousands of fully-human antibodies generated by its VelocImmune mice, which have been modified genetically to have a human immune system, and also antibodies isolated from humans who have recovered from coronavirus.
The scientists selected the two most potent, non-competing, and virus-neutralizing antibodies and have scaled them up for use in clinical trials with the company’s in-house VelociMab and manufacturing capabilities.
The US biotech company said that the two antibodies REGN10933 and REGN10987 non-competitively bind to the critical receptor binding domain (RBD) of the coronavirus’ spike protein, which diminishes the ability of mutant viruses to escape treatment, as shown in upcoming Science publications of preclinical research.
George D. Yancopoulos – Co-Founder, President and Chief Scientific Officer of Regeneron Pharmaceuticals said: “We have created a unique anti-viral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral ‘escape,’ a critical precaution in the midst of an ongoing global pandemic.
“REGN-COV2 could have a major impact on public health by slowing spread of the virus and providing a needed treatment for those already sick – and could be available much sooner than a vaccine. The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines.
“Ultimately, the world needs multiple solutions for COVID-19, and the innovative biopharma industry is collectively working hard to help as many people as possible with a variety of complementary approaches.”