Accropeutics’ oral, selective tyrosine kinase 2 (TYK2) inhibitor /Janus kinase (JAK)1 Inhibitor hit the primary and key secondary endpoints in a Phase 2 clinical trial in moderate-to-severe plaque psoriasis.
This multicenter, randomized, double-blind, placebo-controlled trial randomized (1:1:1:1) 145 Chinese patients with moderate-to-severe plaque psoriasis to receive AC-201 25mg BID, 50mg BID or 100mg daily versus placebo. The primary endpoint was PASI-75 at Week 12. Primary and key secondary endpoints including Psoriasis Area and Severity Index (PASI)-75, PASI-90(75% and 90% reduction in PASI) and static Physician’s Global Assessment (sPGA)-0/1 (score of 0 ‘clear’ or 1 ‘almost clear’) were achieved following 12 weeks of treatment in all three dosing groups of AC-201.
At week 12, PASI-75 response rates were 8.1% for placebo (PBO), 31.4% for 25mg BID, 74.3% for 50mg BID, and 59.5% for 100mg QD. The PASI-90 response rate was 2.7% for placebo, 20% for 25mg BID, 48.6% for 50mg BID, and 24.3% for 100mg daily. The percent of patients achieved sPGA-0/1 were 5.4% for placebo, 71.4% for 50mg BID, 59.5% for 100mg daily, and 31.4% for 25mg BID.
Treatment with AC-201 was well tolerated. There was no serious adverse event (SAE) or AE leading to permanent discontinuation in the study. Majority of treatment emergent adverse events (TEAEs) were mild or moderate in severity. The most common TEAEs reported were upper respiratory tract infection and hypertriglyceridemia.
