HB0034 / Zhejiang Huahai Pharma - LARVOL DELTA

Efficacy and Safety of HB0034 in Patients with Generalized Pustular Psoriasis (GPP) (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Trial primary completion date: Aug 2025 ➔ Feb 2025

Trial primary completion date • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Huaotai Pharmaceutical's subsidiary's innovative drug for rare diseases HB0034 injection has made significant progress in clinical trials [Google translation] (Sina Corp) - P2 | N=33 | NCT06231381 | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | "The announcement shows that the HB0034 injection independently developed by Shanghai Huaotai Biopharmaceutical Co., Ltd...has made significant progress in the key clinical trial for the treatment of acute attacks of generalized pustular psoriasis (GPP)...The specific results of this study will be announced at a medical conference to be held in the near future...The results of the clinical trial showed that compared with the placebo, in the first week after a single intravenous administration of HB0034, the skin pustules of patients with GPP attacks were significantly cleared, achieving the primary study endpoint present in the protocol, and the safety performance was good, and no new safety signals were found....The announcement pointed out that the company's HB0034 has been recognized as an orphan drug by the U.S. Food and Drug Administration (FDA) for the treatment of GPP."

Orphan drug • P2 data • Psoriasis

Peripheral B cell in the patients with generalized pustular psoriasis (GPP) :associated with disease severity and decrease after the treatment of HB0034 (AAD 2025) - P1 | "B cells may contribute to the pathogenesis of GPP. The sample size of our study is limited and further studies are needed."

Clinical • Dermatology • Immunology • Psoriasis • Pustular Psoriasis • CD4 • CD8

A Study to Evaluate HB0034 in Healthy Chinese Adult Participants (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate HB0034 in Healthy Chinese Adult Participants (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

New P1 trial

Dual blockade of IL-17A and IL-36 pathways via a bispecific antibody exhibits enhanced anti-inflammatory potency. (PubMed, Front Immunol) - "To investigate whether dual targeting interleukin-17 (IL-17) and IL-36 enhances anti-inflammatory activity, bispecific Ab HB0043 was generated by linking the single chain fragment variables (scFvs) from humanized anti-IL-36R antibody (HB0034) to the C-terminus of the heavy chain of anti-IL-17A IgG1 (HB0017) Fc using a flexible peptide linker...In a mouse model of Oxazolone (OXA)-induced atopic dermatitis and Imiquimod (IMQ)-induced skin inflammation, administration of both anti-IL17A mAb HB0017 and anti-mouse IL-36R surrogate antibody HB0034SA showed improved effectiveness in alleviating skin thickening and inflammation based on histological assessment...Together, dual blockade of IL-17A and IL-36R in the form of a bispecific antibody may have advantages in blocking the overlapping and non-overlapping functions of these two cytokines in skin inflammation that could not optimally be curtailed with single mAbs. In conclusion, as monotherapy may reach therapeutic celling..."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Fibrosis • Immunology • Inflammation • CXCL8 • IL17A • IL6

Limited Self-Resolution of GPP Flare with Moderate-to-Severe Intensity: An Analysis from the HB0034 Phase Ib Study (EADV 2024) - P1 | "The study suggests that spontaneous resolution of moderate-to-severe GPP flares is limited, which highlights the necessity of therapeutic intervention in managing GPP. This observation aligns with the findings from the placebo group in two other GPP trials (Effisayil TM 1 and the GEMINI-1 study) . However, the small sample size necessitates further research to confirm these results."

P1 data • Dermatology • Immunology • Psoriasis • Pustular Psoriasis • Rheumatology

Long-Term Safety and Efficacy of HB0034 in Subjects with Generalized Pustular Psoriasis (clinicaltrials.gov) - P2/3 | N=33 | Recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

New and Emerging Treatments for Generalized Pustular Psoriasis: Focus on IL-36 Receptor Inhibitors. (PubMed, Pharmaceutics) - "Until recently, no specific treatment modalities were available, and treatment for GPP followed the guidelines for the treatment of plaque psoriasis, consisting of conventional treatments, such as retinoids, methotrexate, and even biologics, which although effective in some cases, may be associated with significant side effects, necessitating more effective and safe options...Spesolimab and imsidolimab, two recently developed therapeutic agents, target the IL-36 inflammatory pathway by binding to the IL-36 receptor (IL-36R)...IL-36 receptor inhibitors demonstrated great efficacy and good safety profile in the management of patients with GPP, demonstrating their potential to emerge as a leading treatment option. This review aims to explore and summarize the current scientific literature on the most recently developed treatments for GPP."

Journal • Review • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis (clinicaltrials.gov) - P2/3 | N=33 | Not yet recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

New P2/3 trial • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

HB0034 improves patient-reported outcomes in patients with generalized pustular psoriasis: Results from the HB0034 Ib study (EADV-Sp 2024) - P1 | "Patients with GPP treated with HB0034 achieved improvements in PROs by Week 1, which continued to improve and sustain over 12 weeks. Sex and works or school were mostly impacted in DLQI. We first demonstrated the positive correlation between PROs and disease severity in GPP."

Clinical • Patient reported outcomes • Dermatology • Immunology • Inflammation • Psoriasis • Pustular Psoriasis

Efficacy and Safety of HB0034 in Patients With Generalized Pustular Psoriasis (GPP) (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Efficacy and Safety of HB0034 in Patients With Generalized Pustular Psoriasis (GPP) (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

New P2 trial • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

HB0034 in Patients With Generalized Pustular Psoriasis (GPP) (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Mar 2023 ➔ Jun 2023

Trial completion date • Trial primary completion date

Zhejiang Huahai Pharmaceutical Co., Ltd. Announcement on Subsidiary Products Obtaining Orphan Drug Designation from the U.S. FDA [Google translation] (Shanghai Securities News) - "Recently, Shanghai Huaotai Biopharmaceutical Co., Ltd...released its product HB0034 injection ( Anti-IL-36R monoclonal antibody) has received orphan drug designation from the U.S. Food and Drug Administration (hereinafter referred to as "U.S. FDA") for the treatment of generalized pustular psoriasis (GPP)."

Orphan drug • Immunology • Psoriasis

HB0034, a novel anti-IL-36R inhibitor, showed a promising efficacy in controlling acute GPP flare (EADV 2023) - "HB0034 demonstrated favorable safety, and PK properties in Phase Ia study. Preliminary results from on-going Phase Ib study showed promising efficacy in controlling the GPP flare and improving quality of life. However, further studies are required to determine the clinical efficacy, duration of effect, and adverse events associated with the drug."

Clinical • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Mar 2023 | Trial primary completion date: Oct 2023 ➔ Mar 2023

Trial completion • Trial completion date • Trial primary completion date

HB0034 in Patients With Generalized Pustular Psoriasis (GPP) (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Oct 2022 ➔ Oct 2023

Enrollment open • Trial primary completion date • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate HB0034 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Sep 2022

Trial completion • Trial completion date

HB0034 in Patients With Generalized Pustular Psoriasis (GPP) (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

New P1 trial • Dermatology • Immunology • Psoriasis

A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

New P1 trial

A Study to Evaluate HB0034 in Healthy Adult Participants (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open