Policy & Regulation
Innovent doses first hypercholesterolemia patient in China in Phase IIa Clinical Study of IBI306
21 March 2019 -

Biopharmaceutical company Innovent Biologics Inc (HKEX:01801) reported on Wednesday the start of treatment of the first patient under its Phase IIa clinical study of IBI306 for the treatment of hypercholesterolemia in China.

Hypercholesterolemia is a serious issue in China due to unhealthy diet and lifestyles and aging population. Dyslipidemia caused by hypercholesterolemia is a major risk factor for cardiovascular mortality. Although some lipid-lowering medicines are on the market, the overall control rate of dyslipidemia is not satisfactory.

The Phase IIa study, which will be conducted in China, is a randomized, double-blind, placebo-controlled, multiple ascending dose clinical study to evaluate the efficacy, safety, tolerability, as well as pharmacokinetics (PK) and pharmacodynamics (PD) profiles of IBI306, in repeatedly different doses, for treating hypercholesterolemia.

As part of the Phase IIa study, about 60 patients with hypercholesterolemia will be enrolled in the study in China.

According to the company, IBI306 is a recombinant fully human anti-proprotein convertase substilisin/kexin type 9 (anti-PCSK9) monoclonal antibody drug candidate for the treatment of hypercholesterolemia. Preclinical studies have confirmed that it reduces low-density lipoprotein cholesterol (LDL-C) levels by reducing PCSK9-mediated low-density lipoprotein (LDL) receptor endocytosis. IBI306 can be potentially dosed with a long dosing interval.