Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a pivotal Phase III clinical study. The multi-center, randomized, double-blinded, placebo-controlled trial is designed to evaluate the efficacy of QX005N, a monoclonal antibody (mAb) targeting IL-4Rα for the treatment of nodular prurigo (NP), a skin disease.
In a previous Phase II study for NP, QX005N demonstrated significant efficacy with a higher proportion of effective subjects across the dosage groups (300 mg, 450 mg, 600 mg) compared to the placebo group at week 16, as measured by the Worst Itch Numeric Rating Scale (WI-NRS). The drug also showed an overall good safety and tolerability profile.
QX005N has been granted breakthrough therapy designation (BTD) in China for the treatment of NP and has received approval to advance into clinical studies for a range of other conditions, including moderate to severe atopic dermatitis, adolescent atopic dermatitis, chronic sinusitis with nasal polyps, spontaneous urticaria, asthma, and chronic obstructive pulmonary disease.- Flcube.com
