IBI306 is a recombinant fully human immunoglobulin G 2 (lgG2) monoclonal antibody.
It can attach to and hinder proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9) mediated low-density lipoprotein receptor (LDL-R) endocytosis for lowering low-density lipoprotein cholesterol (LDL-C) levels.
The randomised, double-blind, placebo-controlled Phase III trial analysed the efficacy and safety of IBI306 in 148 Chinese participants with HeFH.
The percentage decrease from baseline in LDL-C following 12 weeks of therapy was the trial’s primary efficacy goal.
According to the data from the trial, IBI306 treatment lowered LDL-C levels substantially in HeFH patients who had prior statins and/or ezetimibe treatment, as against placebo.
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Furthermore, IBI306 showed a favourable safety profile, which is in line with previously reported safety outcomes of other marketed PCSK-9 inhibitors.
Innovent Biologics Special Diseases Medical Sciences and Strategies executive director Dr Lei Qian said: “As a novel PCSK-9 inhibitor developed by Innovent with independent intellectual property rights, previous study results showed that IBI306 could effectively reduce TC and LDL-C levels in patients with hypercholesterolemia, and the success of CREDIT-2 further validated the efficacy of IBI306 and was also a key step in the registration of IBI306.
“We hope to provide clinicians with an effective, safe, and more accessible treatment option through innovative development strategies and solid research design, so as to achieve the goal of benefiting more patients with hypercholesterolemia.”
IBI306 showed beneficial efficacy and favourable safety in a Phase I trial in healthy participants and a Phase IIa trial in hypercholesterolemia patients.
Familial hypercholesterolemia is an autosomal dominant inheritance ailment that is characterised by increased levels of blood cholesterol because of genetic abnormalities.
In March this year, Innovent dosed the first subject in a Phase Ia clinical trial of a potential recombinant anti-CD47/PD-L1 bispecific antibody (IBI322) in the US for treating patients with advanced malignancies.