Innovent Announces First Patient Dosed in a Phase IIa Clinical Study of IBI306, an Anti-PCSK9 Monoclonal Antibody
SUZHOU,China,March 21,2019 --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 IIaclinical 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. Wehope that IBI306 can eventuallybenefit patients with cardiovascular diseases," said Michael Yu,Founder,Chief Executive Officer and Chairman of Innovent.
About IBI306
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. IBI306preliminarydemonstrated 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.
About Innovent
Inspired by the spirit of "Start with Integrity,Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011,Innovent is committed to developing,manufacturing and commercializing high quality innovative medicines for the treatment of oncology,autoimmunity and other major diseases. On October 31,2018,Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since it was founded,Innovent has developed a fully-integrated platform which includes R&D,CMC (Chemistry,Manufacturing,and Controls),clinical development and commercialization capabilities. Leveraging the platform,the company has built up a robust pipeline of 20 innovative assets in the fields of oncology,ophthalmology,autoimmunity,and cardiovascular diseases. Fourteen assets have entered into clinical development,four have entered Phase III clinical trials,two monoclonal antibodies have their New Drug Application (NDA) under review,and one,Tyvyt® (sintilimab injection),is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).
Innovent has built an international team of advanced talents in high-end biological drug development and commercialization,including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company,Adimab,Incyte,Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry,improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information,please visit：www.innoventbio.com.
