Accropeutics' TYK2/JAK1 Inhibitor Shows Promise in Phase 2 Psoriasis Trial

Chinese biotech company Accropeutics has announced positive results from a phase 2 clinical trial of its TYK2/JAK1 inhibitor, AC-201, for the treatment of moderate to severe plaque psoriasis. The study, conducted in China, met its primary and secondary endpoints, demonstrating significant improvements in psoriasis symptoms across multiple dosing regimens.

Trial Results and Efficacy

The phase 2 trial enrolled 145 Chinese patients with moderate to severe plaque psoriasis, who were randomized to receive one of three doses of AC-201 or placebo. The primary endpoint was the proportion of patients achieving a 75% improvement on the Psoriasis Area and Severity Score (PASI 75) at Week 12 compared to placebo.

Results showed that all three dose cohorts met the primary endpoint:

• 25 mg twice daily: 31.4% PASI-75 response rate
• 50 mg twice daily: 74.3% PASI-75 response rate
• 100 mg daily: 59.5% PASI-75 response rate
• Placebo: 8.1% PASI-75 response rate

The 50 mg twice-daily dose demonstrated the highest efficacy, with nearly three-quarters of patients achieving the PASI-75 threshold. This dosing regimen also showed the strongest performance in the secondary endpoint of PASI-90, with 48.6% of patients achieving a 90% improvement in psoriasis symptoms.

Safety Profile and Tolerability

AC-201 was reported to be well-tolerated across all dosing regimens. No serious adverse events or discontinuations due to adverse events were observed during the study. The most common treatment-emergent adverse events were mild to moderate in severity, primarily consisting of upper respiratory tract infections and elevated blood triglyceride levels.

Competitive Landscape and Future Development

The positive results for AC-201 position Accropeutics as a potential competitor in the growing market for TYK2 inhibitors. For comparison, Bristol Myers Squibb's Sotyktu (deucravacitinib), a selective TYK2 inhibitor approved for psoriasis in 2022, demonstrated PASI-75 response rates of 53% and 58% in its phase 3 trials at 16 weeks.

Accropeutics CEO and co-founder Xiaohu Zhang, Ph.D., expressed enthusiasm about the results, stating, "We are excited to see the positive results from the phase 2 study of AC-201, and we will accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases."

The company plans to advance AC-201's clinical development program, potentially expanding into other autoimmune indications. This progress comes on the heels of Accropeutics securing $12 million in Series B funding earlier this year, which was partly allocated to support the development of its pipeline, including AC-201 and other candidates targeting RIPK2 and RIPK1 for ulcerative colitis and acute graft-versus-host disease, respectively.