Huaotaibio Announces Completion of Full Patient Enrollment in Pivotal Phase II Trial of HB0034 (Anti-IL-36R Monoclonal Antibody) for Generalized Pustular Psoriasis

Nov 08, 2024 17:26 CST Updated 17:26

Huaota

Biological New Drug Developer

Abstract

A subsidiary of Zhejiang Huahai Pharmaceutical Co., Ltd.,Shanghai Huaota Biopharmaceutical Co., Ltd.(hereinafter referred to as "Huaota") announced: The pivotal Phase II clinical trial of HB0034 (anti-IL-36R monoclonal antibody) for the treatment of acute exacerbation of generalized pustular psoriasis (GPP) (HB0034-04, NCT06231381）InAll subjects were successfully enrolled on November 8, 2024.

This is the first pivotal clinical trial of a domestically developed anti-IL-36R monoclonal antibody in China.

This pivotal clinical study, led by Professor Zhang Jianzhong from Peking University People's Hospital, was conducted across 29 clinical centers in China. It aimed to evaluate the efficacy and safety of HB0034 in patients with acute exacerbations of moderate to severe generalized pustular psoriasis.

About Generalized Pustular Psoriasis

Generalized Pustular Psoriasis (GPP) is a severe and potentially life-threatening rare skin disease.In China, approximately 14 out of every 1 million people suffer from GPP, with around 20,000 patients. The main characteristic of GPP is the sudden appearance of visible pustules on the skin, which gradually increase and aggregate into extensive and dense "pus lakes." This may be accompanied by systemic symptoms such as fever, fatigue, and joint pain, and in severe cases, it can even be life-threatening.

Generalized Pustular Psoriasis has been included in China's "Second Batch of Rare Disease Catalog" in 2023.

About HB0034

HB0034 is a humanized monoclonal antibody of the IgG1 type targeting IL-36R independently developed by Huaota. It has high affinity for IL-36R, can specifically bind to IL-36R, and competitively blocks the binding of receptor agonists (IL36α, β, and γ) to IL-36R. Numerous studies have shown that the IL-36 signaling pathway is closely related to the pathogenesis of GPP, and IL-36 is a key cytokine leading to inflammatory cycles, skin inflammation, pustule formation, and abnormal tissue remodeling. Therefore, blocking the IL-36 inflammatory pathway signal can reduce the release of pathogenic cellular inflammatory factors in inflammatory diseases, thereby achieving therapeutic effects.

HB0034 has been obtainedOrphan Drug Designation by the U.S. Food and Drug Administration (hereinafter referred to as "U.S. FDA") for the treatment of Generalized Pustular Psoriasis (GPP)。

About Huaota

Huaota Biopharmaceuticals is a biopharmaceutical company focused on independent research and development with a global outlook, specializing in the development of novel biologics for cancer and autoimmune diseases.Currently available11Projects in the clinical stage: including those that have entered pivotal clinical trials, the first self-developed treatment in China for pustular psoriasis (a rare disease).IL-36RMonoclonal antibody; and currently in clinicalIIIn the period, positive signals have been observed in multiple tumor diseases such as endometrial cancer and non-small cell lung cancer.PD-L1/VEGFDual Antibody: The First with Dual Killing Effects Targeting Refractory TumorsCD73-ADCAnd other core projects.

Huaota is currently actively seeking domestic and international partners to jointly advance and co-develop, aiming to provide high-quality, advanced biopharmaceuticals to the global market. The goal is to meet the widespread patient demand for accessible and affordable biologics, striving to change the world through innovation!