Regeneron has begun clinical development of its anti-SARS-CoV-2 antibody combination REGN-COV2. The adaptive phase 1/2/3 clinical trials will assess the effects of the antibodies on hospitalized and nonhospitalized COVID-19 patients.
Having validated the application of its platform to infectious diseases with an Ebola drug, Regeneron quickly emerged as a front-runner in the race to develop antibodies against the coronavirus. Eli Lilly ultimately became the first company to get an anti-SARS-CoV-2 antibody candidate into humans, but Regeneron has followed close behind by hitting its mid-June target.
Regeneron is kicking its clinical development program off with two trials, one in hospitalized patients and another in nonhospitalized patients. In the first part of the trial, Regeneron will look at virologic and safety endpoints before adding clinical endpoints into the mix in phase 2. The phase 1 and 2 trials will inform the design and size of phase 3 studies in each population.
Decoding COVID-19’s Achilles’ Heel to Inspire New Treatments
As the highly infectious novel coronavirus continues to spread, scientists are looking for new ways to kill the virus. While Gilead Sciences’ repurposed antiviral remdesivir has shown activity against COVID-19, its clinical benefits may be limited, creating a demand for better treatments.Now, Ernesto Estrada at the University of Zaragoza in Spain has found what could be the Achilles’ heel of SARS-CoV-2, the virus that causes COVID-19. It’s a protein that’s essential for the reproduction of the virus, making it an excellent target for potential drugs, he believes.The protein is called the main protease (Mpro). It’s an enzyme that cuts precursor molecules that are translated from viral RNA to make functional viral proteins. Proteases are attractive drug targets because of their vital role in viral replication.
NIH Launches Study to Assess Drug for Children with COVID-19
The National Institutes of Health (NIH) on Wednesday launched a study to evaluate drugs prescribed to treat COVID-19, the respiratory disease caused by the new coronavirus, among children and adolescents across the United States.The medical research center said researchers will investigate several treatments, including antiviral and anti-inflammatory drugs, and will leverage an existing clinical trial examining off-label drugs prescribed to them for various other medical conditions.NIH, a component of the U.S. Department of Health and Human Services, said the study will analyze drug dosage and safety for special populations, including premature infants, critically ill children, children with down syndrome, and obese children.