Sorrento Therapeutics has initiated a Phase 2 trial of its CoviDrops intranasal neutralizing antibody in COVID-19 patients in the UK, the company said. The trial is expected to enroll 350 COVID-19 patients who have mild symptoms or are asymptomatic who will get either 10 mg or 20 mg of CoviDrops via nasal instillation or placebo. Treatment and assessment will take place in the patients’ homes.
Phase 2 trials are also getting underway in the US, Sorrento said, adding that if results of the Phase 2 trials are positive, it will apply for Emergency Use Authorization in the US, UK, Canada, India, Mexico, and the European Union.
According to Sorrento, a Phase 1 study conducted earlier this year demonstrated that the safety of doses up to 60 mg was comparable to placebo. Preclinical data presented in October 2020 showed that the neutralizing antibody was effective against the SARS-CoV-2 virus in a hamster model. The company says that subsequent tests have shown that that CoviDrops is effective in vitro and in animal models against the Alpha and Delta variants as well as the original virus.
Read the Sorrento Therapeutics press release.
