Innovent Biologics has dosed the first subject in a first-in-human Phase I trial of IBI3002 to treat asthma.
The double-blind, randomised, placebo-controlled, single ascending dose (SAD) trial has begun dosing participants in Australia.
It is designed to assess the tolerability, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of IBI3002 in both healthy individuals as well as those with mild to moderate asthma.
IBI3002 is an interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP) directed bispecific antibody.
IL-4Rα and TSLP are both implicated in the pathophysiology of type 2 (T2) inflammatory disorders.
The antibody’s mechanism involves the dual-blocking of IL-4Rα and TSLP, which are central to cytokine signalling pathways in T2 inflammation, a common feature in asthma.
In-vitro assays have indicated that IBI3002 may have superior efficacy compared to existing monoclonal antibodies targeting the same molecules.
The potential of IBI3002 to suppress both T2 and non-T2 inflammation could represent a significant advancement in the treatment of inflammatory ailments.
Innovent Clinical Development vice-president Dr Lei Qian 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.”
Last month, Innovent reported positive results from its Phase III RESTORE-1 clinical trial of IBI311 in Chinese patients with thyroid eye disease (TED), meeting the primary endpoint.
The RESTORE-1 trial was a randomised, multicentre, placebo-controlled double-masked study evaluating the safety and efficacy of IBI311 for TED.
