Enanta Pharmaceuticals Inc (ENTA)

[DewDiligence]

SRNE encounters some safety questions in phase-1b trial of SARS-CoV-2 protease inhibitor:

https://www.globenewswire.com/news-release/2023/01/09/2585304/0/en/Sorrento-Releases-Positive-Results-from-a-Phase-1b-Study-in-China-in-COVID-19-Patients-and-is-Ready-for-Pivotal-Phase-3-trials-with-OVYDSO-STI-1558-an-Oral-Mpro-Inhibitor-as-a-Stan.html

A total of 12 subjects reported an AE in the SAD portion of the study, with one AE of elevated blood thyroid-stimulating hormone (TSH) deemed related to STI-1558 in the 2000 mg cohort.

…In the MAD portion of the study in COVID-19 patients, 20 subjects from a total of 46 subjects reported AEs, with only four subjects experiencing STI-1558-related events. These four AEs included two subjects with mild or moderate liver enzyme elevation (ALT/AST) without bilirubin elevation in the 300 BID and 800 BID cohorts, one subject with mild hyperuricemia in the 600 mg BID cohort and one subject with mild rash in the 800 mg BID cohort.

This trial was conducted entirely in China.