Sorrento Therapeutics Inc. (NASDAQ: SRNE) stock surged by 1.6% at the last close while the SRNE stock price rises by 5.07% in the after-hours trading session. Sorrento is a pharmaceutical company that focuses on making new and effective treatments for cancer and CVID-19. SRNE is basically an antibody-centric company.
The Medicines and Healthcare Products Regulatory Agency in the United Kingdom has authorized Sorrento’s COVI-DROPS product candidate for a Phase 2 efficacy study, according to SRNE. The proposal was filed on a rolling basis, and the MHRA approved the research in less than a month after Sorrento’s initial submission. The safety results from a healthy subject trial done in the United States, which demonstrated a safety profile equivalent to placebo with dosages up to 60 mg, backed up the application. There were no major adverse events or dose-limiting toxicities in this research, and all adverse effects were minor. The maximum dose that could be tolerated was not attained.
The Phase 2 efficacy experiment is a major double-blind clinical experiment that enrolled 350 COVID-19 patients who were asymptomatic or had minor symptoms in a 2:2:1 randomization with patients getting 10mg, 20mg, or placebo. This trial will complement the Phase 2 study that is already underway in the United States and a second experiment that will begin in Mexico.
COVI-DROPS uses the same neutralizing antibody-drug material as COVI-AMG, the intravenous formulation, and is provided as an intranasal insertion in each nares to newly infected individuals. The antibody is effective against both the original SARS-CoV-2 virus and the most common viral versions that are now infecting the United Kingdom and the United States. Concerning versions include the UK/Alpha and India/Delta variations.
The outcomes of this Phase 2 study in the UK will be integrated with the results of Phase 2 trials in the United States and Mexico, and if the findings show that COVI-DROPS is both medically beneficial and effective against SARS-CoV-2, Sorrento will apply for Emergency Use Authorization in the United States, India, the United Kingdom, Mexico, and other territories.