Accropeutics Announces Positive Data from Phase 2 Trial of AC-201, an oral, selective TYK2/JAK1 Inhibitor, for the treatment of Moderate-to-Severe Plaque Psoriasis

• Phase 2 primary endpoint of PASI-75 and key secondary endpoints met in all of the three dosing groups at Week 12
• AC-201 was generally well tolerated at all dose levels with no SAEs or AEs leading to discontinuation
• Efficacy and safety findings from this Phase 2 trial support advancing AC-201 into Phase 3 development for plaque psoriasis.

NEW YORK and SUZHOU, China, May 21, 2025 /PRNewswire/ -- Accro Bioscience (Suzhou) Limited (Accropeutics), a clinical-stage biotech company focused on molecular mechanisms of regulated cell death and related pathogenesis in human diseases, today announced positive results from their Phase 2 clinical trial of AC-201, an oral, selective TYK2/JAK1 Inhibitor, in moderate-to-severe plaque psoriasis. 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 3 dosing groups of AC-201.

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 QD versus placebo. The primary endpoint was PASI-75 at Week 12.

At week 12, PASI-75 response rates were 8.1% for placebo (PBO), 31.4% for 25mg BID (P=0.012 vs. PBO), 74.3% for 50mg BID (P<0.001 vs. PBO), and 59.5% for 100mg QD (P<0.001 vs. PBO). The PASI-90 response rate was 2.7% for placebo, 20% for 25mg BID (P=0.02 vs. PBO), 48.6% for 50mg BID (P<0.001 vs. PBO), and 24.3% for 100mg QD (P=0.007 vs. PBO). The percent of patients achieved sPGA-0/1 were 5.4% for placebo, 71.4% for 50mg BID (P<0.001 vs. PBO), 59.5% for 100mg QD (P<0.001 vs. PBO), and 31.4% for 25mg BID (P=0.004 vs. PBO).

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.

Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics, said, "We are excited to see the positive results from the phase II study of AC-201, and we will accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases."

About AC-201

AC-201 is a novel, highly selective and potent oral small-molecule inhibitor of TYK2/JAK1 that binds to the pseudo kinase domain (JH2) of TYK2/JAK1, without having any effects on the JAK2/JAK2 signaling pathway. It is currently being developed to treat immune mediated inflammatory diseases such as psoriasis and systemic lupus erythematosus. AC-201 has successfully completed long-term nonclinical in vivo toxicology testing, including reproductive toxicity. Phase 1 studies of AC-201 in healthy volunteers conducted in Australia and China demonstrated an excellent safety and tolerability profile, supporting advancement into Phase 2. These studies showed dose proportional PK, no significant drug accumulation upon multiple dosing, and absence of clinically relevant food effect. Low to middle doses of AC-201 were effective in inhibiting disease causing pro-inflammatory cytokines, consistent with AC-201's mechanism of action.

About Accropeutics

Accropeutics is a clinical-stage biotech company with core focus on the molecular mechanisms of regulated cell death and related pathogenesis in human diseases. The company has developed a robust portfolio of innovative drug candidates spanning from lead optimization to clinical development. The RIPK1 inhibitor AC-003 had completed phase 1 clinical trials in China and the United States, obtained Orphan Drug Designation from the FDA, and is currently in a phase 1b trial for the treatment of aGVHD patients. The RIPK2 inhibitor AC-101 completed phase 1 testing in Australia and China with excellent safety and PK/PD data, and the 1b trial in UC patients is ongoing. AC-201, a selective TYK2/JAK1 inhibitor with therapeutic potential across a broad range of immune mediated inflammatory diseases, has completed a phase 2 clinical trial in Psoriasis with first-rate efficacy and safety findings. Accropeutics owns global rights of all the abovementioned assets with 24 patents issued in China, Japan, Korea, US and EU.

Contact: [email protected]