China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its multi-center, double-blinded, randomized, placebo-parallel controlled pivotal study for HB0034, a Category 1 biologic product for acute generalized pustular psoriasis (GPP), has achieved the primary efficacy endpoint and all secondary efficacy endpoints.
Study Results
GPP is a rare, life-threatening, systemic neutropenic skin disease characterized by systemic erythema and pustules, accompanied by systemic inflammatory symptoms. The acute onset of GPP is directly related to death and can lead to sepsis and multiple system organ failure if not controlled in a timely manner.
In the study, HB0034, the first home-grown anti-IL-36R antibody, achieved clearance of pustules in patients with GPP within the first week after a single intravenous administration compared to placebo, reaching the pre-set primary endpoint. Additionally, the drug demonstrated a good safety profile with no new safety signals observed.-Fineline Info & Tech
Leave a Reply