Sorrento reports safety and pharmacokinetic data from Phase I study of STI-1558

Sorrento Therapeutics released Topline safety and pharmacokinetic data from the Phase I single ascending dose/multiple ascending dose study of STI-1558 conducted in 58 healthy volunteers in Australia. "Topline safety and PK data from the SAD and MAD portions of the study are now available. Overall, there were no changes in vital signs, physical examinations, or ECGs resulting from study participation. STI-1558 was well-tolerated at the doses studied, with most subjects reporting no AEs. There was no dose limiting toxicity and no severe or serious adverse events, premature discontinuation of STI-1558 due to an AE, or deaths. Most AEs were mild and unrelated. A total of 11 subjects reported an AE in the SAD part of the study, with 3 AEs of headache deemed related to STI-1558 – one moderate severity in the 600 mg cohort and two mild cases in the 1200 mg cohort – possibly due to restricted caffeine intake. In the MAD part of the study, 13 subjects reported AEs, with only two subjects experiencing related events of mild or moderate liver enzyme elevation without bilirubin elevation in the highest dose cohort, 800 mg BID, which is 33% higher for 50% longer than the planned treatment regimen for Phase II, 600 mg BID for 5 days. The liver enzyme elevations occurred late in study treatment and resolved without the need for any treatment," the company reported. "The unblinded safety and PK data in the Australia trial and the preliminary efficacy data from the China trial in participants infected with SARS-CoV-2 are very encouraging, and we are engaging with regulatory agencies on global Phase II/III trial design in order to initiate the STI-1558 Phase II/III trials in Mexico, the US and China as soon as possible," stated Henry Ji, Ph.D., President and CEO of Sorrento.