On June 14th, Gallopharm (02509.HK) announced that the phase II clinical trial (CTR20223174) of QX005N injection for the treatment of nodular prurigo (PN) was orally presented at the 29th Annual Meeting of Chinese Dermatological Association. This trial is the first clinical trial of biologics for PN indications conducted by a Chinese company. Based on the data of this trial, QX005N was included in the list of breakthrough therapeutic drugs by the drug evaluation center of the National Medical Products Administration on January 31st this year.

This clinical study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study designed to evaluate the effectiveness and safety of multiple subcutaneous injections of QX005N injection in adult PN patients, as well as to observe pharmacokinetic characteristics, pharmacodynamics effects and immunogenicity. A total of 120 subjects were randomly assigned to the 300mg group (first dose of 600mg), 450mg group, 600mg group and placebo group in a 1:1:1:1 ratio. They were given medication every two weeks for 16 weeks, followed by an 8-week follow-up period, for a total study duration of 24 weeks.

The results of the study showed that the primary endpoints of all dose groups were fully achieved. In terms of WI-NRS score, the proportions of patients achieving an improvement of ≥4 points compared to baseline at week 16 were 76.7%, 83.3% and 76.7% in the 300mg, 450mg and 600mg groups, respectively, which were significantly better than the 30.0% in the placebo group (P<0.0001), demonstrating the significant efficacy of QX005N in relieving itching. In addition, QX005N quickly took effect in the first week of medication and maintained its efficacy in relieving itching until the end of the 24-week follow-up after the medication was stopped at week 16.

In terms of improving skin lesions, the proportions of patients achieving an IGAPN-S score of 0 or 1 at week 16 were 26.7%, 30.0%, 16.7% and 6.7%, respectively, in the 300mg, 450mg, 600mg and placebo groups; the proportions of patients achieving an IGAPN-A score of 0 or 1 at week 16 were 30.0%, 50.0%, 33.3% and 10.0%, respectively, in the four groups, both of which were significantly better than those in the placebo group.

In terms of safety, the administration of QX005N injection for 16 weeks was safe and well tolerated, with no grade 3 or higher drug-related adverse events (AEs), no drug-related serious adverse events (SAEs), and no other special safety signals observed.