Innovent Biologics has announced that the first patient has been successfully dosed in a Phase IIa clinical study of IBI306, a recombinant anti-proprotein convertase substilisin/kexin type 9 (anti-PCSK9) monoclonal antibody, to treat hypercholesterolemia.
The placebo-controlled, double-blind, randomised, multiple ascending dose clinical trial is being conducted in China.
Under repeatedly different doses, the trial will evaluate the efficacy, tolerability, safety, as well as pharmacodynamics (PD) and pharmacokinetics (PK) profiles of IBI306.
IBI306 binds to proprotein convertase substilisin/kexin type 9 (PCSK9) molecules. Furthermore, by reducing PCSK9-mediated low-density lipoprotein (LDL) receptor endocytosis, IBI306cuts down low-density lipoprotein cholesterol (LDL-C) levels.
Under the Phase I study, IBI306 preliminarily indicated good tolerability and acceptable safety profiles and offered prolonged dose-dependent reduction of LDL-C levels in healthy subjects.
The Phase IIa study will see enrollment of 60 patients with hypercholesterolemia.
Peking University First Hospital director of the department of pharmacy Yimin Cui said: “IBI306 was well tolerated and had an acceptable safety profile in the Phase I trial in healthy subjects. Furthermore, it reduces blood lipid levels in a dose-dependent manner. One unique feature of IBI306 is it can be potentially dosed with a long dosing interval. The results are encouraging.”
Innovent chairman, founder and CEO Michael Yu said: “IBI306 is a Category I biological innovative drug candidate developed by Innovent for the treatment of hypercholesterolemia. It has shown acceptable safety and good tolerability profile in Phase Ia study. We are looking forward to rapidly moving IBI306 into late-stage clinical development. We hope IBI306 can eventually benefit patients with cardiovascular diseases.”
Hypercholesterolemia is considered to be a grave issue in China as a result of unhealthy diet, lifestyles and aging population.
Dyslipidemia caused due to hypercholesterolemia is considered to be a major risk factor for cardiovascular mortality.