- The stock price of Sorrento Therapeutics Inc (NASDAQ: SRNE) increased by 6.65% today. This is why it happened.
The stock price of Sorrento Therapeutics Inc (NASDAQ: SRNE) increased by 6.65% today. Investors responded positively to Sorrento Therapeutics announcing that the Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom’s regulatory agency, cleared Sorrento’s COVI-DROPS product candidate for a Phase 2 efficacy trial.
The application was submitted as a rolling application and the MHRA cleared the study in under a month from Sorrento’s first submission to the MHRA. And the application was supported by the safety data from a healthy subject study completed in the US — which showed a safety profile comparable to placebo with doses up to 60 mg. In the study, there were no serious adverse effects or dose-limiting toxicities and all adverse effects were mild in severity. The maximum tolerated dose was not reached.
The Phase 2 efficacy trial is a large double-blind clinical trial enrolling 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms in a 2:2:1 randomization with patients receiving 10mg, 20mg, or placebo. This trial complements the Phase 2 trial currently being started in the US and a separate trial to be started in Mexico.
COVI-DROPS are administered as an intranasal instillation in each nares to recently infected patients and utilize the same neutralizing antibody drug substance as COVI-AMG (the intravenous formulation). And the antibody is active against the original SARS-CoV-2 virus as well as the most prevalent viral variants of concern (VoCs) currently infecting the UK and the US. These variants include the UK (Alpha) and the India (Delta) variants of concern.
The results of the Phase 2 trial in the UK will be combined with the results of the US and Mexico Phase 2 trials. And if the results of these studies demonstrate that COVI-DROPS is both safe and effective against SARS-CoV-2, then Sorrento will apply for Emergency Use Authorization in the US, India, UK, Mexico and European Union as well as other territories.
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.
