SRNE - Sorrento wins FDA go-ahead for early-stage STI-2099 COVID-19 trial

Sorrento Therapeutics (SRNE) has received clearance from the FDA for its Investigational New Drug application ((IND)) for its Phase 1 study of the safety and pharmacokinetics of intranasal ((IN)) STI-2099 ((COVIDROPS)) in both healthy volunteers and patients with mild COVID-19.Initial trials are expected to be followed by a Phase 2 trial in both mild and moderate COVID-19 patients, either as a stand-alone nasal application or as a combination nasal and intravenous administration.The company highlighted that this is the first FDA clearance of a clinical trial of intranasal administration of a neutralizing antibody against the SARS-CoV-2 virus.Shares up nearly 5% post market.The FDA had also cleared Sorrento to initiate clinical trail of internally developed anti-CD47 monoclonal antibody, STI-6643, earlier on Tuesday.

For further details see:

Sorrento wins FDA go-ahead for early-stage STI-2099 COVID-19 trial