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.
UCB reports positive Phase 3 results for fenfluramine in CDKL5 deficiency disorder
WuXi AppTec's Nantong site receives 2025 Architizer A+Award
MGI partners with Negedia to enhance genomic sequencing in Italy
Speranza Therapeutics partners with Sunshine Labs for harm reduction solutions
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Aptamer Group signs development and licensing deal with global life sciences partner
Scancell expands Phase 2 SCOPE trial with new intradermal dosing arm for iSCIB1+
Telix Pharmaceuticals delivers first commercial doses from Belgian manufacturing hub
CivicaScript introduces low-cost multiple sclerosis treatment
Innovent presents mazdutide Phase 3 clinical study results at ADA 85th Scientific Sessions
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress