Shanghai, China, April, 8th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient was dosed in a global multicentre phase 3 clinical trial of HLX04-O, a recombinant anti-VEGF humanised monoclonal antibody injection jointly developed by the company and Essex, in Latvia, a member of the European Union (EU), for the treatment of wet age-related macular degeneration (wAMD). In November 2021, the first patient has been dosed in a phase 3 clinical trial in China for HLX04-O for the treatment of wAMD.
This two-part, multicentre, global phase 3 study aims to compare the efficacy and safety of HLX04-O with ranibizumab in patients with wet age-related macular degeneration (wAMD). Part 1 is an open-label safety run-in portion, of which the primary objective is to evaluate the safety and tolerability of HLX04-O. Eligible patients will receive intravitreal injection of HLX04-O (1.25 mg) every 4 weeks for up to 1 year. Part 2 is a randomised, double-blind, active-controlled, non-inferiority study. Eligible patients will be randomised 1:1 to receive intravitreal injection of HLX04-O (1.25 mg) or ranibizumab (0.5 mg) every 4 weeks for up to 1 year. The primary objective is to compare the efficacy of HLX04-O with ranibizumab at Week 48 in patient’s study eye with wAMD. The primary endpoint is the mean change from baseline in the best-corrected visual acuity (BCVA) at Week 48. Secondary objectives include the evaluation of other efficacy endpoints, safety, tolerability and pharmacokinetic profiles.
In addition to Latvia, the clinical trial applications of HLX04-O had been approved in the United States, the EU (Spain, Czechia, Poland, etc.), Australia, Singapore and other countries and regions. Through the cooperation with Essex, Henlius will speed up the global multicentre clinical trials of HLX04-O and apply marketing authorization in China, Australia, the European Union and the United States around the globe based on the research results. HLX04-O has the potential to be one of the first bevacizumab approved for ophthalmic diseases, benefiting more patients with eye diseases worldwide. Looking forward, Henlius will continue advancing the development of innovative biologics on the basis of its established and integrated innovation platform, underscoring its long-term commitment to providing affordable and effective therapies for patients worldwide.
About wAMD
Age-related macular degeneration is one of the leading causes of visual impairment and blindness in the elderly worldwide[1]. According to the World Health Organization (WHO), about 30 million people have suffered from AMD globally, and about half a million people become blind due to AMD each year[2]. Wet age-related macular degeneration (wAMD) is characterized by the formation of subretinal choroidal neovascularization (CNV) and is responsible for approximately 90% of cases of AMD-related blindness. Due to an aging population, wAMD has become a serious social medical problem and indicated a huge burden of unmet need[3]. With the development of treatment for fundus diseases, anti-VEGF drugs are becoming the first-line therapy for the management of wAMD[4], and the efficacy and safety of vitreous injection of bevacizumab for wAMD have been verified in multiple clinical studies[5-11].
About HLX04-O
HLX04-O is a recombinant anti-VEGF humanized monoclonal antibody injection constructed using genetic engineering technology independently developed by Henlius. HLX04-O can inhibit VEGF’s binding to its receptor Flt-1(VEGFR-1) and KDR(VEGFR-2) on endothelial cells to inhibit the activation of its tyrosine kinase signaling pathway, inhibit endothelial cell proliferation and reduce angiogenesis, thereby treating eye diseases associated with angiogenesis. According to the requirements of ophthalmic drugs, the Company has developed HLX04-O which optimizes the prescription, specifications and production processes of HANBEITAI, assuming that the active ingredients remain unchanged. Through a series of comparability analysis, it is proved that the changes in the production process and prescription of the preparation have no adverse impact on the quality, safety and efficacy of the preparation.
Reference
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