InnoCare Pharma has announced that its Phase II clinical study of the Tyrosine Kinase 2 (TYK2) inhibitor ICP-488 for psoriasis treatment met the primary endpoint.
The multicentre, randomised, double-blind, placebo-controlled study was designed to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ICP-488 in adult Chinese patients with moderate-to-severe plaque psoriasis.
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This study enrolled a total of 129 patients, who were randomised in a 1:1:1 ratio to three treatment groups to receive 6mg once-daily, 9mg once-daily and a placebo for 12 consecutive weeks.
The results demonstrated that ICP-488 has an excellent efficacy and safety profile in the treatment of psoriasis.
ICP-488 achieved multiple efficacy endpoints including significant improvements in the Psoriasis Area and Severity Index (PASI) scores and the static Physician’s Global Assessment (sPGA) scores in both dosing groups.
After 12 weeks of treatment, PASI 75 was achieved by 77.3% and 78.6% of patients in the 6mg and 9mg groups, respectively, compared with just 11.6% in the placebo group.
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By GlobalDataPASI 90 was reached by 36.4% and 50% of patients, respectively, with no patients in the placebo group reaching this level.
Additionally, PASI 100 was achieved by 11.4% and 11.9% of patients, respectively, and sPGA 0/1 was reached by 70.5% and 71.4%, compared with 9.3% for placebo.
The safety profile of ICP-488 was also found to be favourable with most treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) being mild or moderate.
An oral, selective TYK2 allosteric inhibitor, ICP-488 functions by binding to the JH2 domain, blocking signal transduction of various inflammatory cytokines, and thereby inhibiting the pathological process of autoimmune and inflammatory diseases.
InnoCare co-founder, chairwoman and CEO Dr Jasmine Cui said: “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.”
