Sorrento Completes Successfully the SAD Study and Initiates the MAD Phase 1 Study with STI-1558, An Oral M(pro) Inhibitor as a Standalone Treatment and Prevention of COVID-19 without the Ritonavir as Booster
Single ascending dose (SAD) Phase 1 Study completed in Australia with a maximum dose of 2,000 mg.
Pharmacokinetics (PK) were dose proportional and PK modeling and preclinical data support a 600 mg twice daily dose.
There were no serious AEs (SAEs) or severe TEAEs and the maximum tolerated dose (MTD) was not reached.
Initiation of the multiple ascending dose (MAD) portion of the STI-1558 study has been initiated.
Excerpt from the Press Release:
SAN DIEGO, Aug. 03, 2022 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced the completion of the SAD portion of the Phase 1 study of its oral main viral protease (Mpro) inhibitor, the STI-1558.
The Phase 1 safety and PK study in healthy volunteers was conducted in Australia. The MPR-COV-101AU study is entitled: “A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of STI-1558 in Healthy Volunteers”. In the SAD portion of the study, 4 dose-escalation cohorts (single oral dose of 300, 600, 1200, and 2000 mg STI-1558 or placebo) with 8 subjects in each cohort randomized 3:1 (except for Cohort 2 for the fasted and fed dosing with 10 subjects randomized 4:1).
Only the preliminary blinded safety and PK data from the SAD portion of the study is available. Overall, there were no changes in vital signs, physical examinations, ECGs or safety clinical labs resulting from study participation. The preliminary overall summary of treatment-emergent adverse events (TEAEs), showed that there were no serious AEs (SAEs) or severe TEAEs and the maximum tolerated dose was not reached. No dose limiting toxicity was noted and there were no premature terminations from the study post treatment and no deaths during the study.
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