Huaota Bio's IL-36R Monoclonal Antibody HB0034 Granted FDA Orphan Drug Designation for Generalized Pustular Psoriasis

Oct 20, 2023 09:34 CST Updated 09:34

Huahai Pharmaceutical

Medical and Health Product Provider

Huaota

Biological New Drug Developer

On October 18, Huahai Pharmaceutical announced that its subsidiary, Huaota Biopharmaceutical, is currently researchingAnti-IL-36R Monoclonal AntibodyHB0034 Injection Granted Orphan Drug Designation by U.S. FDA forTreatment of Generalized Pustular Psoriasis (GPP)According to the announcement by Huahai Pharmaceutical, the granting of FDA Orphan Drug Designation to HB0034 injection will provide opportunities to benefit from relevant policy support in terms of product development, registration, and commercialization.

GPP is a rareCommon Skin DiseasesUnlike common psoriasis, this disease is clinically characterized by widespread outbreaks of pus-filled blisters (pustules) on the skin, accompanied by pain, and may be associated with systemic symptoms such as high fever. GPP can present as recurrent or persistent episodes during its course, potentially leading to hospitalization and even life-threatening complications, including heart failure, renal failure, and sepsis. The unpredictable nature and severity of the disease greatly impact the patient's quality of life.

HB0034 is a humanized IgG1 (Immunoglobulin G1) monoclonal antibody targeting IL-36R (Interleukin-36 Receptor). It can specifically bind to IL-36R and block the signaling of the IL-36 inflammatory pathway.. This product competitively blocks the binding of receptor agonists (IL36α, β, and γ) to IL-36R by binding to IL-36R, downregulates downstream pro-inflammatory and pro-fibrotic signaling pathways, and inhibits epithelial cell/fibroblast/immune cell-mediated inflammatory responses, therebyReduce Inflammatory Diseases/Skin Conditions(Including generalized pustular psoriasis, inflammatory bowel disease, systemic lupus erythematosus, fibrotic diseases)The release of cell inflammatory factors driven by central mechanisms, to achieve the purpose of controlling the disease.

Preclinical studies have demonstrated,HB0034Significantly inhibits imiquimod-induced psoriasis-like symptoms in cynomolgus monkeys, such as erythema, scaling, and skin thickening, indicating its strong biological activity in vivo.。At the same time, by modifying the Fc segment, the HB0034 was reduced or even eliminated to a certain extent.Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC)AndComplement-Dependent Cytotoxicity (CDC)Function, good safety and tolerability, with potential for development as an anti-inflammatory agent.

In July 2022, the National Medical Products Administration (NMPA) of China approved to conduct in ChinaHB0034 InjectionPhase 1b Clinical Trial. This is a multicenter, open-label, single-arm study evaluating the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in patients with moderate to severe generalized pustular psoriasis experiencing acute flares.

References:

[1]Huahai Pharmaceutical Co., Ltd. Announcement on Subsidiary's Product Receiving U.S. FDA Orphan Drug Designation. Retrieved Oct 18, 2023, From http://www.cninfo.com.cn/new/disclosure/detail?stockCode=600521&announcementId=1218058311&orgId=gssh0600521&announcementTime=2023-10-18

[2] China's First IL-36R-Targeted Monoclonal Antibody Administers First Dose to a Subject in New Zealand. Retrieved Dec 9, 2022, from https://www.huaota.com/newsshow/125.html

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