In topline phase 3 results, nomelcitinib improved PASI 90 and PGA 0/1 responses versus placebo in plaque psoriasis

1. Nomelcitinib, a tyrosine kinase 2 (TYK2) inhibitor, achieved significantly higher Psoriasis Area Severity Index (PASI) 90 and Physician Global Assessment (PGA) 0/1 response rates than placebo at week 16 (p<0.0001).

2. The company reported no new safety signals during the study, but full results have not been peer reviewed.

Evidence Rating Level: 2 (Good)

2MM Brief: InventisBio Co. reported topline results from a registrational Phase III study of nomelcitinib in patients with moderate-to-severe plaque psoriasis. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 391 patients, who were randomly assigned in a 1:1:1 ratio to two nomelcitinib treatment groups or placebo; follow-up for the primary analysis was through week 16. Nomelcitinib is an oral selective TYK2 inhibitor. The primary endpoint was the percentage of patients achieving at least a 90% improvement from baseline in PASI score (PASI 90), or PASI 90, at week 16. The key secondary endpoint was the percentage achieving a PGA score of 0 or 1 with a reduction of ≥2 points from baseline, or PGA 0/1, at week 16. Both nomelcitinib treatment groups achieved PASI 90 in over 70% of patients, significantly exceeding the placebo group (p<0.0001). More than 80% of patients in the nomelcitinib groups achieved PGA 0/1, also significantly exceeding placebo (p<0.0001). The company reported that other secondary efficacy endpoints consistently favored nomelcitinib and that, by week 4, both treatment groups had significantly higher proportions of patients achieving PASI 90 and PGA 0/1 than placebo. Exact response estimates, confidence intervals and P values beyond those reported above were not provided. Nomelcitinib was described as well tolerated, with no new safety signals identified during the study. These are topline results from InventisBio and have not been peer reviewed; the release did not provide detailed adverse-event data, treatment discontinuation data or longer-term follow-up. This study supports further evaluation of nomelcitinib for moderate-to-severe plaque psoriasis, but the available findings do not establish its comparative efficacy against an active treatment.

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