Novel TYK2 inhibitor ICP-488 shows efficacy, safety in plaque psoriasis

Key takeaways:

• Among ICP-488-treated patients, 77.3% to 78.6% achieved PASI 75 by week 12 vs. 11.6% of the placebo group.
• The majority of treatment-emergent and treatment-related adverse events were mild or moderate.

ICP-488 demonstrated “excellent” efficacy and safety for the treatment of moderate to severe plaque psoriasis in adults, InnoCare Pharma announced in a press release.

“Psoriasis requires long-term management, and there remains a significant unmet medical need for new treatments,” Jasmine Cui, PhD, co-founder, chairwoman and CEO of InnoCare, said in the release. “We are excited to see the positive results from the phase 2 study of ICP-488, and we will further accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases.”

The oral, novel tyrosine kinase 2 inhibitor was evaluated in this phase 2 study among 129 Chinese adult patients with moderate to severe plaque psoriasis. Patients were randomly assigned to receive 6 mg of ICP-488 once daily, 9 mg once daily or placebo for 12 weeks.

Results showed that the study achieved its primary endpoint with 77.3% and 78.6% of the 6 mg and 9 mg groups, respectively, achieving PASI 75 by week 12 vs. 11.6% of the placebo group (P < .0001).

Similarly, 36.4% and 50% of the 6 mg and 9 mg groups achieved PASI 90 and 11.4% and 11.9% achieved PASI 100 vs. 0% of the placebo-treated patients (P < .0001 and P < .05).

Static Physician Global Assessment 0/1 was also reached by 70.5% and 71.4% of the 6 mg- and 9 mg-treated patients compared with 9.3% of the patients in the placebo group (P < .0001).

According to the release, ICP-488 also demonstrated a good tolerability and safety profile with most treatment-emergent and treatment-related adverse events considered mild or moderate.