Sorrento Gets FDA OK for Phase 1 Trial of Covid Antibody Drug - TheStreet

Sorrento Gets FDA OK for Phase 1 Trial of Covid Antibody Drug

Sorrento is targeting a potential emergency use authorization submission as early as this year.
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Sorrento Therapeutics  (SRNE) - Get Report shares skyrocketed Thursday after the biopharmaceutical company received Food and Drug Administration approval for a Phase 1 trial of its neutralizing coronavirus antibody for hospitalized coronavirus patients.

The drug is called Covi-Guard (STI-1499).

Sorrento shares traded at $11.16, up 33.49%, in premarket trading. The stock has soared 147% year to date through Wednesday but has declined 33% over the past month.

“The initial trial is expected to enroll rapidly and is expected to be followed by large trials targeting a potential Emergency Use Authorization submission as early as ... this year,” the company said in a statement.

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

Sorrento has begun manufacturing 50,000 doses in anticipation of a potential emergency use authorization.

“As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in such preclinical in vitro studies,” the company said.

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

Dozens of other companies are working on coronavirus treatments/vaccines as well. President Trump has said a vaccine will be available in three to four weeks, but scientists scoff at that notion, saying it will take much longer.