QX004N, a humanized immunoglobulin G1 gamma monoclonal antibody targeting interleukin-23 (IL-23), has shown promising results in a Phase 1 clinical trial for the treatment of moderate to severe plaque psoriasis. The study, conducted by researchers at the First Hospital of Jilin University in Changchun, China, suggests that QX004N could be a safe and effective alternative to existing IL-23 inhibitors like risankizumab (Skyrizi).
The trial consisted of two parts: a Phase 1a study in healthy participants and a Phase 1b study in patients with plaque psoriasis. The Phase 1b study, a 24-week, double-blind, randomized, placebo-controlled, multiple dose-escalation trial, involved 30 patients with moderate to severe plaque psoriasis. Patients were assigned to receive either 150 mg, 300 mg, or 600 mg of QX004N, or placebo, administered as single injections at weeks 0, 2, and 4.
Efficacy Outcomes
The results of the Phase 1b trial demonstrated significant efficacy for QX004N. Notably, 100% of patients in the 150 mg, 300 mg, and 600 mg QX004N groups achieved PASI 75 at week 12 and PASI 90 at week 16, compared to only 33.3% in the placebo group. Furthermore, all patients in the QX004N groups reached an Investigator's Global Assessment (IGA) score of 0 or 1, while the highest proportion in the placebo group achieving the same was 66.7%.
Safety Profile
In terms of safety, 87.5% of QX004N-treated patients reported treatment-emergent adverse events, compared to 66.7% in the placebo group. In the Phase 1a study with healthy volunteers, the most commonly reported drug-related treatment-emergent adverse events included hypertriglyceridemia, hyperuricemia, hematuria, increased blood uric acid and decreased neutrophil count. Most adverse events were considered grade 1 or 2, with one grade 3 event (hypertriglyceridemia) and one serious adverse event (biochemical pregnancy/abortion) deemed possibly unrelated to the study drug. No deaths were reported.
Implications for Psoriasis Treatment
"These results support the continued development of QX004N as a potential treatment option for patients with moderate to severe plaque psoriasis, demonstrating its potential to substantially improve patient outcomes," the authors concluded. The efficacy and safety profile observed in this Phase 1 trial warrants further investigation in larger, Phase 2 and 3 clinical trials to confirm these findings and establish the optimal dosing regimen for QX004N.
