Sorrento Therapeutics Inc. (NASDAQ: SRNE) gained 1.6% after announcing the UK’s regulatory agency Medicines and Healthcare products Regulatory Agency cleared its COVI-DROPS candidate for a second phase efficacy study.
MHRA clears Sorrento’s COVI-DROPS Application
The company submitted the application as a rolling application with the MHRA clearing the trial within a month following the first submission to the agency. The safety data from a healthy subject trial done in the US, which demonstrated a safety profile comparable to placebo with doses up to 60 mg, backed the application. There were no significant adverse events or dose-limiting toxicities in this research, and all adverse effects were minor. However, the study didn’t attain the maximum dose that could be tolerated.
The Phase 2 efficacy study is a massive double-blind clinical study that will enroll 350 COVID-19 asymptomatic outpatients or those with mild symptoms. The company will randomize patients in a 2:2:1 randomization with patients getting 10mg, 20mg, or placebo. This study will complement the Phase 2 study already underway in the US and another study that will begin in Mexico.
Sorrento to file EUA based n phase 2 results
COVI-DROPS uses the same neutralizing antibody-drug material as COVI-AMG, the intravenous formulation, and is provided as an intranasal insertion in each nasal passages to recently infected patients. The antibody is effective against both the original SARS-CoV-2 virus and the most common viral variants of concern (VOCs) now spreading in the United Kingdom and the United States.
The results of the second Phase trial in the UK will be compared to the Phase 2 trials in the United States and Mexico. If the findings show that COVI-DROPS is both effective and safe against SARS-CoV-2, Sorrento will file for a EUA in the UK, the US, Mexico, India, and the EU.