Innovent Biologics, Inc. issued the following announcement on March 20.
Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, today announced that the first patient has been successfully dosed in a Phase IIa clinical study of IBI306, a recombinant fully human anti-proprotein convertase substilisin/kexin type 9 (anti-PCSK9) monoclonal antibody, for the treatment of hypercholesterolemia.
The Phase IIa study conducted in the People's Republic of China (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 the treatment of patients with hypercholesterolemia. 60 patients with hypercholesterolemia will be enrolled in the study.
"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 I study of IBI306 has shown promising results. I hope IBI306，a recombinant fully human monoclonal antibody, will provide a better treatment option for patients with cardiovascular diseases," said Professor Yong Huo, Director of the Department of Cardiology, Peking University First Hospital.
"IBI306 was well tolerated and had an acceptable safety profile in the Phase 1 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," said Professor Yimin Cui, Director of the Department of Pharmacy at Peking University First Hospital.
"IBI306 is a Category 1 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 that IBI306 can eventually benefit patients with cardiovascular diseases," saidMichael Yu, Founder, Chief Executive Officer and Chairman of Innovent.
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 IBI306's mechanism of action. It specifically binds to proprotein convertase substilisin/kexin type 9 (PCSK9) molecules and reduces low-density lipoprotein cholesterol (LDL-C) levels by reducing PCSK9-mediated low-density lipoprotein (LDL) receptor endocytosis. The investigational new drug（IND）application for IBI306 was approved by the National Medical Products Administration (NMPA) in September 2017. IBI306 preliminary demonstrated good tolerability and acceptable safety profiles and delivered prolonged dose-dependent reduction of LDL-C levels in healthy subjects in Phase I study. One unique feature of IBI306 is it can be potentially dosed with a long dosing interval. This profile suggests that IBI306 could potentially provide additional benefits to patients with hypercholesterolemia, when compared with existing therapies.
Original source can be found here.