Huaota Biopharma Launches Phase 3 Trial of IL-17A Monoclonal Antibody HB0017 with Potential for Once Every 2–3 Months Dosing

China Drug Clinical Trial Registration and Information Disclosure Platform official website disclosed that Huabio and Huaota Bio have initiated a clinical evaluation of HB0017 injection for treatment.Moderate to Severe Plaque PsoriasisA multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study on the efficacy and safety of HB0017, which is independently developed by Huaota.Monoclonal Antibody Targeting Interleukin-17A (IL-17A), intended for development to treat moderate to severe plaque psoriasis and ankylosing spondylitis. In previous Phase 1 clinical studies, the product demonstrated an advantage in terms of half-life,There is hope for a maintenance treatment regimen that supports dosing once every 2-3 months in future clinical practice, greatly improving the convenience of medication for patients.。

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure

Psoriasis is a chronic, recurrent, inflammatory, and systemic disease induced by the interaction of genetic and environmental factors and mediated by the immune system. Clinically, it presents as scaly erythematous plaques or patches that may be localized or widely distributed. Psoriasis can be associated with systemic diseases, significantly impacting the patient's quality of life.IL-17A is a hallmark cytokine involved in the generation of inflammation and disease progression in psoriasis and ankylosing spondylitis, playing a cornerstone role in the pathogenesis.。

HB0017 is aAnti-IL-17A monoclonal antibody. The product has currently completed a Phase 1a study in healthy subjects conducted in New Zealand, and a Phase 1b study in patients with moderate to severe plaque psoriasis conducted in China. Meanwhile, explorationHB0017Phase 2 Clinical Study on Different Dosing Regimens for Moderate to Severe Plaque Psoriasis Completes Enrollment of All Patients

This Phase 3 clinical study initiated by Huaota Biopharmaceutical in China aims to demonstrate the efficacy endpoint of HB0017 Injection in treating moderate to severe plaque psoriasis at Week 12.Clearance of Skin Symptoms（The responder rate of PASI75 and sPGA 0/1 was superior to placebo. The secondary objective was to evaluate other efficacy endpoints, long-term safety, tolerability, pharmacokinetic characteristics, immunogenicity, and pharmacodynamics of HB0017 injection for the treatment of moderate to severe plaque psoriasis. The principal investigator of this study isProfessor Jianzhong Zhang from Peking University People's Hospital。

November 2023,Huaota Biopharmaceuticals AnnouncesIn international academic journalsBritish Journal of DermatologyPublished a Phase 1 clinical study article on HB0017. The study evaluated the efficacy and safety of HB0017 in healthy subjects and patients with moderate to severe plaque psoriasis. The research showed that HB0017 had good safety and tolerability, particularly in terms of pharmacokinetics, with a significantly longer half-life compared to other drugs targeting the same pathway.This will support the maintenance treatment regimen of HB0017 administered once every 2 to 3 months in future clinical use.At the same time, the preliminary significant efficacy results confirmed the therapeutic potential of HB0017 in moderate to severe plaque psoriasis.Patients in the 300mg dose group achieved 100% skin symptom clearance (PASI 90).。

Huaota Biopharmaceuticals stated in an earlier press release that based on HB0017's current strong performance, it has the potential to offer patients suffering from long-term chronic pain worldwide a more durable, safe, and effective treatment option.