China-based Qyuns Therapeutics (HKEX: 2509) reported detailed Phase III results for oturkibart (QX005N), its anti-IL-4Rα monoclonal antibody, in adults with moderate-to-severe prurigo nodularis (PN), presenting the data as a late-breaking oral at the 35th European Academy of Dermatology and Venereology Congress in Vienna.
The multicenter, randomized, double-blind, placebo-controlled study enrolled 412 patients across 62 centers in China and randomized them 1:1 to 450 mg oturkibart or placebo subcutaneously every two weeks. Participants had an inadequate response to topical therapies such as medium-to-high potency topical corticosteroids or were considered unsuitable for such treatment.
At Week 24, 74.5% of oturkibart-treated patients achieved a ≥4-point reduction in weekly average Worst Itch Numerical Rating Scale (WI-NRS) score versus 29.0% on placebo (P<0.0001), meeting the primary endpoint. The key secondary endpoint was also met, with 34.7% versus 11.1% achieving an Investigator's Global Assessment Prurigo Nodularis Stage score of 0 or 1 (P<0.0001).
At Week 52, 95.5% of patients receiving continuous oturkibart and 90.6% of those who switched from placebo achieved a ≥4-point WI-NRS reduction from baseline. Qyuns said treatment-emergent and serious adverse events at Week 24 were similar to placebo, most adverse events were mild to moderate, and no new safety signals emerged during longer-term treatment.
Oturkibart (QX005N; Huadong Medicine development code HDM3016) is a recombinant humanized monoclonal antibody targeting IL-4Rα, blocking signaling mediated by both IL-4 and IL-13.