Innovent Biologics, Inc. (HKEX: 01801), a China-based biopharmaceutical company, announced on Thursday that it has dosed its first participant in a first-in-human (FIH) phase one clinical trial of IBI3002, a global first-in-class bispecific antibody targeting Interleukin 4 receptor alpha (IL-4R alpha) and thymic stromal lymphopoietin (TSLP), in Australia.
This FIH study (NCT06213844), a randomised, double-blind, placebo-controlled, single ascending dose (SAD) study, is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) (only in subjects with asthma) of IBI3002 in healthy subjects and participants with mild to moderate asthma, and to support the product's further global clinical development.
IBI3002, a humanised bispecific antibody targeting cell surface IL-4R alpha and the alarmin cytokine TSLP, has been discovered and developed by the firm for the treatment of inflammatory diseases, which includes asthma. It has high-efficient dual-blocking function on both IL-4R alpha and TSLP.
Dr Lei Qian, Innovent vice president of Clinical Development, said, 'In the last few decades, knowledge about both pathophysiological mechanisms, clinical phenotypes and therapeutic options for asthma have significantly increased. In particular, the introduction of biologics for severe asthma paved the way to a true revolution in the field of asthma management, by potentially allowing a precision medicine approach. Targeting specific steps of the immune-inflammatory cascade through highly selective drugs represents a true revolution in the field of severe asthma management, and brings with it the potential of achieving optimal disease control in different severe asthma inflammatory phenotypes. We are looking forward to the development of this molecule in asthma and other inflammatory diseases.'
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