Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced the NMPA clearance of a Phase I study of its oral main viral protease (Mpro) inhibitor, STI-1558, in subjects with COVID-19 in a MAD study in China.
In a previously announced Australia Phase I study in healthy subjects, the SAD portion with four dose cohorts (300 mg, 600 mg, 1200 mg, and 2000 mg) has been completed. The MAD portion of the study is starting and STI-1558 has been well tolerated to date with only a few related adverse events, which have been transient and mild in severity. The PK profile has matched the predicted values based on the animal studies and confirms that STI-1558 is readily absorbed by humans with high bioavailability and no need for ritonavir, a potent cytochrome P450 3A4 inhibitor, to block metabolic clearance to maintain effective blood levels. In the NMPA cleared Phase I trial, STI-1558 will be administered to subjects with COVID-19 with mild or no symptoms in this MAD study, allowing for an evaluation of the safety, tolerability, and efficacy of STI-1558 as a standalone treatment without ritonavir as a booster.
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