#China #Suzhou #Accropeutics #Plaque Psoriasis #AC-201

Positive Phase 2 Trial Results for AC-201

Accro Bioscience (Suzhou) Limited, widely known as Accropeutics, has achieved significant success in its Phase 2 clinical trial for AC-201, an oral selective inhibitor targeting TYK2/JAK1. This promising treatment is designed for moderate to severe plaque psoriasis, a chronic inflammatory skin condition that afflicts millions worldwide. The results revealed that the therapy met its primary and key secondary endpoints, showing effective reduction in psoriasis symptoms following a 12-week treatment regimen.

Trial Overview

The Phase 2 trial was a multicenter, randomized, double-blind, placebo-controlled study that enrolled 145 patients from China suffering from moderate to severe plaque psoriasis. Participants were assigned to receive one of three AC-201 dosing regimens: 25mg BID, 50mg BID, or 100mg QD, or a placebo. The primary endpoint focused on the achievement of a PASI-75 response at the 12-week mark, an indicator of significant improvement in the severity and extent of psoriasis plaques.

According to the data released, the PASI-75 response rates at week 12 were remarkably positive: the placebo group achieved an 8.1% response rate, while the 25mg BID group reached 31.4%. The 50mg BID group showed an impressive 74.3% response (P<0.001 vs. placebo), and the 100mg QD group achieved a 59.5% response rate (P<0.001 vs. placebo). Furthermore, the results indicated that 48.6% of participants on the 50mg BID dosage achieved a PASI-90 response, further showcasing the treatment's effectiveness.

Safety and Tolerability

AC-201 was well tolerated across all dosage levels in the study, with no serious adverse events (SAEs) or adverse events (AEs) resulting in treatment discontinuation. The majority of treatment-emergent adverse events (TEAEs) were mild to moderate in nature; notably, upper respiratory tract infections were the most frequently reported TEAE, alongside incidents of hypertriglyceridemia. These results suggest a favorable safety profile, reinforcing the potential for this therapy in treating psoriasis sufferers.

Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics, expressed optimism regarding the trial outcomes, stating, "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.”

Insights on AC-201

AC-201 stands as a novel, highly selective, oral small-molecule inhibitor that primarily targets the TYK2 and JAK1 pathways while avoiding interference with the JAK2/JAK2 signaling pathway. Its mechanism of action positions it as a potential game-changer in treating various immune-mediated inflammatory diseases, including systemic lupus erythematosus and more. Previous Phase 1 studies in healthy volunteers indicated an excellent tolerability profile, setting a strong foundation for advancing to the next clinical phase.

As part of its broader development strategy, Accropeutics is committed to addressing a range of immune-mediated inflammatory conditions. The company has successfully navigated the regulatory landscape, holding 24 issued patents across several countries such as China, the United States, Japan, Korea, and throughout the EU. This broad patent protection underscores their competitive edge in the biotech field.

Conclusion

As Accropeutics gears up for Phase 3 trials of AC-201, the results of this Phase 2 study offer a promising glimpse into the potential impact of this therapy for those suffering from plaque psoriasis. The journey from clinical trials to market can be long and arduous, but with a solid foundation of effectiveness and a favorable safety profile, AC-201 could soon provide a new lease on life for patients battling this chronic condition.