Essex Bio-Technology announces phase 1/2 clinical trial of EB12-20145P (HLX04-O) is complete

Essex Bio-Technology Ltd announced a phase 1/2 clinical trial of EB12-20145P (HLX04-O), a recombinant anti-VEGF humanized monoclonal antibody injection jointly developed by the company and Shanghai Henlius Biotech Inc. has been completed in patients with wet age-related macular degeneration (wAMD).

According to a news release from the companies, the results of this study demonstrated the good safety and tolerability of HLX04-O. Moreover, the first patients in the United States, China, the European Union (EU) and Australia have been dosed in phase 3 clinical trials (NCT04740671)of EB12-20145P (HLX04-O) for the wAMD.

This single-arm, open-label, multicenter, phase 1/2 study aimed to evaluate the safety and preliminary efficacy of HLX04-O via intravitreal injection (IVT) in patients with active wAMD.

The companies noted the study consisted of two parts. Part 1 was a safety run-in stage that enrolled 6 patients. Part 2 was a single-arm, open-label, multicenter, phase II study and 20 patients (including 6 patients from part 1) were enrolled in this part. All patients received HLX04-O IVT (1.25 mg/0.05 mL) every four weeks until death, withdrawal of informed consent, loss to follow-up, study termination by sponsor, or completion of one-year treatment.

For part 1, the primary endpoint was safety event related to EB12-20145P (HLX04-O) that occurred within four weeks after the first dose of HLX04-O; secondary endpoints were the systemic pharmacokinetic characteristics of HLX04-O after the first and fourth IVT administration.

For part 2, the primary endpoint was the mean change of letters from baseline in best corrected visual acuity (BCVA) at week 12; secondary endpoints included other efficacy measures, safety, immunogenicity, and systemic pharmacokinetic characteristics. The results showed that HLX04-Owas safe and well tolerated in wAMD patients, and preliminary efficacy was observed.

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 signalling pathway, inhibit endothelial cell proliferation and reduce angiogenesis, thereby treating eye diseases associated with angiogenesis. According to the requirements of ophthalmic drugs,

Henlius 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.

As of now, the clinical trial applications of HLX04-O had been approved in Singapore and other countries and regions.

According to the news release, the companies will jointly manage progressively the global multi-center clinical trials of HLX04-O and apply marketing authorization in China, Australia, the EU, and the US around the globe based on the research results. HLX04-O has the potential to be one of the first bevacizumab approved for use in ophthalmic diseases, benefiting more patients with eye diseases worldwide.