Oral TYK2 inhibitor has ‘outstanding efficiency’ in plaque psoriasis

Key takeaways:

• Once-daily ICP-488 significantly improved PASI scores in patients with plaque psoriasis compared with placebo at week 12.
• The safety profile of ICP-488 was similar to placebo.

ORLANDO — A once-daily, oral tyrosine kinase 2 inhibitor was safe and “highly effective” in adults with moderate to severe plaque psoriasis, according to a presenter at the American Academy of Dermatology Annual Meeting.

For the phase 2 trial, Xiaoguang Zhang, MD, PhD, a researcher at The Second Hospital of Hebei Medical University, and colleagues randomly assigned 129 participants aged 18 to 70 years with moderate to severe plaque psoriasis in a 1:1:1 ratio to receive a daily dose of 6 mg ICP-488 (InnoCare), 9 mg ICP-488 or placebo for 12 weeks. After treatment, the researchers followed participants for 28 days to conduct a safety analysis.

The primary endpoint was the proportion of participants who achieved a 75% or greater improvement in PASI scores at week 12. The findings were presented during a late-breaking session at the meeting.

Overall, there was a significant improvement in total PASI score from baseline to week 12 in the 6 mg group (–78%) and 9 mg group (–82.3%) compared with the placebo group (–26.5%), Zhang reported.

She said a high proportion of participants who received ICP-488 achieved the primary endpoint — 77.3% in the 6 mg group and 78.6% in the 9 mg group compared with 11.6% in the placebo group.

There was also a significantly higher proportion of participants in the ICP-488 groups who achieved:

• PASI 50, with 88.6% in the 6 mg group and 92.9% in the 9 mg group vs. 25.6% in the placebo group;
• PASI 90, with 36.4% in the 6 mg group and 50% in the 9 mg group vs. 0% in the placebo group; and
• PASI 100, with about 11% in both ICP-488 groups vs. 0% in the placebo group.

Additionally, more patients in the 6 mg (70.5%) and 9 mg (71.4%) groups achieved a static Physician’s Global Assessment of 0 or 1 compared with placebo (9.3%), meaning their psoriasis cleared or almost cleared, Zhang said.

ICP-488 was safe, with no serious treatment-emergent adverse events related to the drug, she said. Most of the moderate treatment-emergent adverse events were not associated with ICP-488, and no one discontinued treatment due to treatment-related adverse events. Overall, “the safety profile was comparable to placebo,” Zhang added.

“A high proportion of patients achieved PASI 75 in both 6 mg [once-daily] and 9 mg [once-daily] groups — outstanding efficiency observed in main efficiency analyses,” Zhang concluded. “I hope you found the findings as fascinating as we did.”