Phase 2 Trial Demonstrates Efficacy in Psoriasis Treatment

Accropeutics, a Chinese biotech company, announced that its TYK2/JAK1 inhibitor, AC-201, successfully met the primary endpoints in a phase 2 clinical trial targeting moderate to severe plaque psoriasis. The study enrolled 145 patients who were assigned to receive one of three different doses of AC-201 or a placebo. All dosage groups achieved significant improvements in the Psoriasis Area and Severity Index (PASI 75) by Week 12 when compared to placebo. Specifically, the PASI-75 response rates were 31.4% for the 25 mg twice-daily group, 74.3% for the 50 mg twice-daily group, and 59.5% for the 100 mg once-daily group, versus an 8.1% response in the placebo cohort. These results compare favorably with Bristol Myers Squibb’s TYK2 inhibitor Sotyktu, approved in 2022, which demonstrated PASI-75 response rates of 53% and 58% in two phase 3 trials conducted over

 16 weeks.

Secondary Endpoints and Safety Profile

Beyond the primary endpoint, AC-201 also achieved its secondary endpoint measured by PASI 90 across all dosage cohorts, with the highest response of 48.6% observed in the 50 mg twice-daily group. Accropeutics reported that AC-201 was generally well tolerated. No serious adverse events or treatment discontinuations due to side effects were recorded. Most treatment-emergent adverse events were mild to moderate, commonly involving upper respiratory tract infections and elevated blood triglycerides.

Company Outlook and Pipeline Development

In a statement, Accropeutics’ CEO and co-founder, Dr. Xiaohu Zhang, expressed enthusiasm for the trial results and confirmed the company’s intention to expedite clinical development of AC-201 to address psoriasis and other autoimmune diseases. AC-201 stands as the company’s lead candidate. Earlier in March, Accropeutics raised $12 million in Series B financing, intended to advance the clinical development of its RIPK2 inhibitor, AC-101, currently in a phase 1b trial for ulcerative colitis. Additionally, Accropeutics is developing a RIPK1 inhibitor, AC-003, which is undergoing a phase 1b trial for acute graft-versus-host disease.

Competitive Landscape

In the same therapeutic category, Roivant is developing brepocitinib, another TYK2/JAK1 inhibitor licensed from Pfizer in 2022. Although Roivant discontinued brepocitinib’s development for lupus after a phase 2 failure, the drug remains under evaluation for non-infectious uveitis and dermatomyositis.

Highlights

• Accropeutics’ AC-201 met primary and secondary endpoints in a phase 2 trial for moderate to severe plaque psoriasis with significant PASI-75 and PASI-90 improvements.
• The 50 mg twice-daily dose achieved the highest efficacy with a 74.3% PASI-75 and 48.6% PASI-90 response rate.
• AC-201 was well tolerated, with no serious adverse events or treatment discontinuations reported.
• The company plans to accelerate AC-201’s clinical development for psoriasis and other autoimmune diseases.
• Accropeutics’ pipeline includes RIPK2 inhibitor AC-101 in phase 1b for ulcerative colitis and RIPK1 inhibitor AC-003 in phase 1b for graft-versus-host disease.
• Roivant’s brepocitinib remains in development for non-infectious uveitis and dermatomyositis after lupus program discontinuation.