InnoCare Pharma has announced positive results from its Phase II clinical trial of ICP-488, a novel Tyrosine Kinase 2 (TYK2) inhibitor, for the treatment of moderate-to-severe plaque psoriasis. The study, conducted in Chinese adult patients, met its primary endpoint, demonstrating significant efficacy and a favorable safety profile. These findings suggest ICP-488 could offer a valuable new oral treatment option for the millions affected by psoriasis.
The multicenter, randomized, double-blind, placebo-controlled trial enrolled 129 patients who were assigned in a 1:1:1 ratio to receive either 6mg of ICP-488 once daily, 9mg of ICP-488 once daily, or a placebo for 12 weeks. The primary endpoint was based on improvements in the Psoriasis Area and Severity Index (PASI) score.
Significant Efficacy Demonstrated
The results showed that ICP-488 achieved multiple efficacy endpoints. Specifically, after 12 weeks of treatment, 77.3% and 78.6% of patients in the 6mg and 9mg groups, respectively, achieved PASI 75, compared to only 11.6% in the placebo group (p<0.0001). Furthermore, PASI 90 was reached by 36.4% and 50.0% of patients in the 6mg and 9mg groups, respectively, versus 0% in the placebo group (p<0.0001).
Notably, PASI 100, representing complete skin clearance, was achieved by 11.4% and 11.9% of patients in the 6mg and 9mg groups, respectively, compared to 0% in the placebo group (p<0.05). Additionally, a static Physician’s Global Assessment (sPGA) score of 0 or 1 (clear or almost clear) was reached by 70.5% and 71.4% of patients in the 6mg and 9mg groups, respectively, compared to 9.3% in the placebo group (p<0.0001).
Favorable Safety Profile
ICP-488 also demonstrated good tolerability and a favorable safety profile. Most treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) were reported as mild or moderate.
Mechanism of Action
ICP-488 is an oral, potent, and selective TYK2 allosteric inhibitor. It functions by binding to the JH2 domain, which blocks the signal transduction of IL-23, IL-12, type 1 IFN, and other inflammatory cytokines, thereby inhibiting the pathological processes underlying autoimmune and inflammatory diseases.
Addressing Unmet Needs in Psoriasis Treatment
Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, emphasized the importance of these findings, stating, "Psoriasis requires long-term management, and there remains a significant unmet medical need for new treatments. We are excited to see the positive results from the phase II study of ICP-488, and we will further accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases."
With approximately seven million people in China living with psoriasis and the number on the rise, the need for effective and convenient treatments is significant. Current treatment options often fall short, leaving many patients undertreated, particularly those with moderate-to-severe psoriasis. The availability of a new oral medication like ICP-488 could greatly improve the management of this chronic condition.
