Plonmarlimab is a humanised immunoglobulin G1 (IgG1) antibody designed to act on the cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF), which is associated with autoimmune and inflammatory diseases.
GM-CSF neutralisation can suppress inflammatory responses and is expected to be clinically beneficially to patients with autoimmune disorders such as RA.
I-Mab CEO Dr Joan Shen said: “Plonmarlimab is the first antibody of its class entering clinical trials in China. We believe it has the great potential to become a new treatment option as a disease-modifying anti-rheumatic agent.
“Our intention is to achieve proof of concept in RA and expand to broad autoimmune diseases with unmet needs.”
The multi-centre, double-blind, placebo-controlled Phase Ib trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of the drug in 63 patients with RA.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData
Participants will be given a single dose or multiple doses of the therapy for up to eight weeks. The company has completed a first-in-human single ascending dose trial of plonmarlimab in healthy volunteers in the US.
Trial lead investigator Zhan-Guo Li said: “Studies have shown that GM-CSF has a profound role in modulating immune response and suppressing autoimmune diseases.
“We are eager to further investigate and characterise the safety and efficacy profile of plonmarlimab in treating patients with RA, a disease that continues to afflict five million people in China today.”
The company is currently conducting a Phase II trial to treat patients with Covid-19-related cytokine release syndrome in the US.
I-Mab filed an investigational new drug (IND) application with South Korea’s Ministry of Food and Drug Safety (MFDS) to perform a trial of TJM2 to treat cytokine storm in patients with severe or critical Covid-19.