A PHASE 2 clinical trial has demonstrated that a once-daily oral tyrosine kinase 2 (TYK2) inhibitor significantly improves symptoms in adults with moderate to severe plaque psoriasis, achieving high clearance rates with a safety profile comparable to placebo.
Presented at the American Academy of Dermatology Annual Meeting, the study evaluated 129 patients aged 18 to 70 who were randomly assigned to receive 6 mg or 9 mg of ICP-488, or a placebo, for 12 weeks. The primary endpoint was achieving at least a 75% reduction in Psoriasis Area and Severity Index (PASI 75) at week 12.
Both ICP-488 groups showed substantial PASI score reductions from baseline to week 12, with the 6 mg group improving by 78% and the 9 mg group by 82.3%, compared to 26.5% in the placebo group. A high proportion of patients receiving ICP-488 reached PASI 75 (77.3% in the 6 mg group, 78.6% in the 9 mg group) versus just 11.6% in the placebo group.
Additional efficacy endpoints also favored ICP-488, with more patients in the treatment groups achieving:
PASI 50: 88.6% (6 mg) and 92.9% (9 mg) vs. 25.6% (placebo)
PASI 90: 36.4% (6 mg) and 50% (9 mg) vs. 0% (placebo)
PASI 100: ~11% in both treatment groups vs. 0% in placebo
Moreover, physician assessments indicated that 70.5% of patients in the 6 mg group and 71.4% in the 9 mg group achieved almost complete or full clearance, compared to just 9.3% in the placebo group.
ICP-488 was well tolerated, with no serious treatment-related adverse events. The majority of moderate adverse events were not linked to the drug, and no patients discontinued treatment due to adverse effects.
These findings highlight ICP-488 as a promising potential treatment for moderate to severe plaque psoriasis, offering strong efficacy with a favorable safety profile.
Reference: Healio. Diversity remains paramount in research from basic to clinical stages. March 11, 2025. Available at: https://www.healio.com/news/dermatology/20250309/oral-tyk2-inhibitor-has-outstanding-efficiency-in-plaque-psoriasis. Last accessed: March 11, 2025.
Anaya Malik | AMJ
