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July 4, 2022

Innovent Phase II ulcerative colitis antibody trial doses first subject

The trial is assessing the safety and efficacy of IBI112 to treat moderate-to-severe active UC.

Innovent Biologics has dosed the first patient in a Phase II clinical trial of its antibody, IBI112, in China enrolling patients with moderate-to-severe active ulcerative colitis (UC), a chronic inflammatory ailment.

IBI112 is a new recombinant anti-interleukin 23p19 subunit antibody injection.

It attaches to the IL-23p19 subunit to hinder IL-23 from binding to cell surface receptors, resulting in the IL-23 receptor-mediated signalling pathway inhibition. 

The randomised, multicentre, parallel, double-blind, placebo-controlled trial is assessing the safety and the efficacy of IBI112 to treat moderate-to-severe active UC. 

Analysing the safety, efficacy, immunogenicity and pharmacokinetics of IBI112 induction and maintenance treatment in Chinese participants with this disease is the trial’s primary objective.

The latest trial is the first Phase II study of domestic drugs that act on IL-23p19 for patients with UC in the country. 

According to preclinical findings, IBI112 was found to possess a clear target and well-elucidated mechanism of action and substantial anti-inflammatory effect. 

Furthermore, the product was demonstrated to be safe and well-tolerated in the Phase I trial. 

Innovent Clinical Development vice-president Dr Qian Lei said: “Ulcerative colitis is a kind of inflammatory bowel disease characterised by persistent and recurrent diarrhoea, mucus pus and bloody stool, abdominal pain and severe internal emergency. 

“IBI112 plays an anti-inflammatory role by blocking IL-23-mediated signalling pathway and has the potential to treat autoimmune diseases such as inflammatory bowel disease including ulcerative colitis and psoriasis.”

In February this year, the company dosed the first participant in the Phase Ia/Ib trial of its antibody, IBI325, for advanced solid tumours.

This first-in-human, open-label, dose-escalation trial was designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of IBI325 as a single agent and along with sintilimab in patients with advanced solid tumours.

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