Sorrento Therapeutics is set to commence a Phase I clinical trial of its oral therapy, STI-1558, for Covid-19 in China.
The latest development comes after the company received approval from the China National Medical Products Administration (NMPA) for its investigational new drug (IND) application for STI-1558.
The double-blind, placebo-controlled, multiple ascending dose (MAD) trial will enrol 56 patients with mild or no Covid-19 symptoms.
It will have three dose cohorts to analyse 300mg, 600mg, and 800mg twice-a-day doses of STI-1558 and a placebo arm.
To be carried out by the Sorrento company, ACEA Therapeutics, and the Third Shenzhen Hospital in Shenzhen, China, the trial will evaluate the efficacy, safety, and tolerability of STI-1558 for Covid-19.
The viral load in subjects will also be analysed to evaluate STI-1558’s antiviral activity versus a placebo.
The trial is expected to aid in seeking Emergency Use Authorisation (EUA) for STI-1558 in the country.
STI-1558 is an inhibitor of the main viral protease (Mpro).
Sorrento Therapeutics president and CEO 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 US.”
The single ascending dose (SAD) portion of the Phase I trial in Australia that enrolled healthy subjects has concluded.
According to the findings, STI-1558 was found to be well tolerated so far, with a reduced number of associated adverse events, which were transient and mild in nature.
The pharmacokinetics (PK) profile was in line with the predicted values as per the animal studies.
In addition, STI-1558 was found to be absorbed by humans with increased bioavailability, without requiring ritonavir for preventing metabolic clearance to preserve efficient blood levels.
In June this year, the company dosed the first subject in a Phase I trial of STI-1558 for Covid-19 in healthy subjects.