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.
Akeso presents positive results from registrational Phase III study of ivonescimab
FDA grants Priority Review to Genentech's Enspryng for MOGAD
Seismic Pharmaceuticals enrols first patient in istaroxime global Phase 3 trial in cardiogenic shock
BioEdge Research Labs advances transparency in research compound documentation
Insilico Medicine doses first patient in Phase III trial of rentosertib
BridgeBio reports exploratory PROPEL 3 data showing wider clinical trends for oral infigratinib
Tyra Biosciences declares positive Phase 2 results for oral dabogratinib in bladder cancer
Harbour BioMed partner raises USD225m to advance neoadjuvant immuno-oncology therapy porustobart
Kazia Therapeutics doses first patient in paediatric AT/RT study
Fusion Antibodies secures Canadian patent for OptiMAL
Revvity to acquire Human Cell Design to expand metabolic disease drug discovery capabilities
Biophytis expands BIO101 obesity study to assess weight regain
THX Pharma secures European patent for Batten-1 in juvenile Batten disease
Orphalan commences Phase 3 study of trientine therapy in Wilson disease