Qyuns Therapeutics (QYUNS-B) reported that its China Phase III trial of Oturkibart (QX005N), a humanised anti-IL-4Rα monoclonal antibody, met primary and key secondary endpoints in adults with moderate-to-severe prurigo nodularis (PN) who were inadequately controlled on topical corticosteroids.

The multicentre, randomised, double-blind, placebo-controlled study enrolled 412 patients across 62 sites. Participants received either 450 mg Oturkibart or placebo every two weeks for 24 weeks, followed by a 28-week open-label extension and an 8-week safety follow-up.

Efficacy highlights • Primary endpoint achieved: 74.5 % of Oturkibart-treated patients recorded a ≥4-point reduction from baseline in weekly average Worst Itch Numerical Rating Scale (WI-NRS) at Week 24 versus 29.0 % on placebo (P<0.0001). • At Week 52, itch response (≥4-point WI-NRS reduction) rose to 95.5 % in the continuous-treatment cohort and 90.6 % in patients who switched from placebo to Oturkibart. • Deep itch relief (WI-NRS ≤2) at Week 52 was achieved by 76.7 % of continuous-treatment patients and 63.5 % of crossover patients; WI-NRS ≤1 was reached by 55.1 % and 41.3 %, respectively. • Key secondary endpoint met: 34.7 % of Oturkibart patients achieved Investigator’s Global Assessment PN-Stage (IGA PN-S) of 0/1 at Week 24 versus 11.1 % on placebo (P<0.0001). • Lesion clearance continued to improve; Week 52 IGA PN-S 0/1 rates were 66.9 % in the continuous-treatment group and 49.2 % in the crossover group. • Quality-of-life, anxiety and depression metrics showed statistically significant improvements as early as Week 4, with gains sustained through Week 52.

Safety profile Treatment-emergent adverse events and serious adverse events through Week 24 were comparable between Oturkibart and placebo; most events were mild to moderate. No new safety signals emerged over 52 weeks.

Next steps Given the sustained efficacy and favourable tolerability, Qyuns Therapeutics plans to accelerate registration activities for Oturkibart, targeting new-drug application submissions in 2026.