Sorrento gets US FDA nod for Phase 1 clinical trial of neutralising antibody in COVID-19 patients

Sorrento Therapeutics announced that it received a study may proceed letter from the FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalised COVID-19 patients.

As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100 per cent in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in such preclinical in vitro studies.

STI-1499 was further evaluated in preclinical studies using multiple strains of SARS-CoV-2, including the highly contagious D614G variant. In these preclinical studies, the antibody has been 100 per cent effective against the highly contagious D614G variant strain at similar doses to those observed in experiments with the USA-WA1/2020 strain.

Animal data generated in Syrian Golden hamsters infected with SARS-CoV-2 was presented to the FDA in support of a post-exposure human treatment dose for the IND. The effective dose in the hamster model translates to a projected total dose of approximately 160mg for a human patient.

“The highest proposed dose (200 mg per patient) in the phase 1 trial is a lower dose than currently being tested for other known SARS-CoV-2 targeted antibodies or antibody cocktails in active clinical studies. The potentially high potency of STI-1499 antibody may allow for rapid scaling up of manufacturing operations,” informed the company through a statement.

The STI-1499 clinical program is being designed for rapid adaptive expansion, including international sites in Brazil to supplement the US program.