Accropeutics’ oral, selective TYK2/JAK1 inhibitor AC-201 has met the primary and key secondary endpoints in a Phase II psoriasis trial.
The study, which enrolled 145 patients with moderate to severe plaque psoriasis from sites across China, investigated three doses of the therapy (25mg twice daily, 50mg twice daily, and 100mg once daily) versus placebo.
The primary endpoint of Psoriasis Area and Severity Index (PASI)-75 was met with 31.4% for 25mg, 74.3% for 50mg and 59.5% for 100mg, compared to 8.1% for placebo after 12 weeks of treatment.
A key secondary endpoint, PASI-90, also showed improvement in the treatment group, with a response rate of 20% for 25mg, 48.6% for 50mg, and 24.3% for 100mg compared to 2.7% in the placebo arm.
The static Physician’s Global Assessment (sPGA)-0/1 endpoint also showed benefit with 31.4% for the 25mg dose, 71.4% for 50mg, and 59.5% for 100mg versus 5.4% for placebo.
Accropeutics said that efficacy and safety findings from the Phase II trial support advancing AC-201 into Phase III studies in plaque psoriasis.
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By GlobalDataAccropeutics co-founder and CEO Dr Xiaohu Zhang 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.”
Plaque psoriasis market set to grow to $46.1bn
Plaque psoriasis is characterised by well-defined, erythematous plaques covered with silvery scales. These can appear on various body parts but are most commonly found on the scalp, knees, and elbows. The severity of the disease is categorised based on the body surface area affected: moderate psoriasis involves 3% to 10% of the body surface area while severe psoriasis affects more than 10%.
According to GlobalData, the plaque psoriasis market size across the 68 markets in 2030 is set to reach $46.1bn. GlobalData is the parent company of Clinical Trials Arena.
One of the major therapies in the plaque psoriasis space in recent years has been Johnson & Johnson’s (J&J) Stelara (ustekinumab); however, its patent ran out in 2023. Despite this, J&J managed to fend off competition from biosimilars until this year. At least five Stelara biosimilars have since been approved and are now available on the US market.
In November 2024, J&J reported positive top-line data from a Phase III trial of icotrokinra, an investigational, oral peptide that selectively blocks the IL-23 receptor. In the study, around 64.7% of treated patients achieved clear or almost clear skin (IGA scores of 0/1) and 49.6% of patients achieved a PASI 90 response after 16 weeks.
