Sorrento Therapeutics Inc (NASDAQ: SRNE) has revealed the NMPA clearance of a first phase study of the oral main viral protease inhibitor, STI-1558, in individuals with COVID-19 in a MAD trial in China.
The SAD component with four dose groups (300 mg, 600 mg, 1200 mg, and 2000 mg) has now been finished in a previously disclosed Australia Phase I research in healthy patients. There weren’t any serious adverse events or severe treatment-emergent adverse events in the SAD portion of the study.
Sorrento is currently conducting the MAD part of the study.
The MAD part of the trial is currently underway, and STI-1558 has so far demonstrated a good tolerability profile with just a few minor and temporary side effects. In addition, it has been confirmed by the PK profiles that STI-1558 is absorbed quickly by humans, has a strong bioavailability, and does not require the powerful cytochrome P450 3A4 inhibitor ritonavir to prevent metabolic elimination from keeping its effective blood levels.
The double-blind, placebo-controlled MAD study will include 56 patients with minor or no complaints and divided into three dose groups. The viral load of subjects will also be assessed to compare the antiviral effectiveness of STI-1558 therapy in participants with COVID-19 to control therapy, in addition to tolerability and safety evaluations.
Study to support EUA application in China
A Sorrento company, ACEA Therapeutics Inc and the Third Shenzhen Hospital in Shenzhen, China, will carry out the study, supporting the company’s application for an Emergency Use Authorization (EUA) in china. Dr. Lu Hangzhou, president of The Third Shenzhen Hospital and a fellow at the American Academy of Microbiology, will oversee the study.
CEO and President of Sorrento Henry Ji said, “The trial in China will allow us to evaluate STI-1558 antiviral activity in patients together with safety, tolerability and pharmacokinetics in different dose levels. We are looking forward to seeing the results in COVID-19 patients, which we expect to facilitate our planned STI-1558 Phase II/III trials in Mexico and the U.S.”