Immunophage's Second-Tier Global Innovative Drug for IBD Treatment Receives Clinical Trial Approval from the U.S. FDA

Mar 21, 2023

Return to list

Recently, Nanjing Immunophage Biotech Co.,Ltd (referred to as "Immunophage") announced that their globally innovative drug, IPG11406, developed for the treatment of inflammatory bowel disease (IBD), has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). The company will now proceed with clinical trials in the United States. The approved clinical trial in the U.S. will evaluate the safety, tolerability, and pharmacokinetics of IPG11406 in healthy adult subjects. It will be a randomized, double-blind, placebo-controlled, single-dose and multiple-dose escalating Phase I clinical trial.

As one of Immunophage's second-tier projects, IPG11406 is a novel small-molecule GPCR antagonist developed for autoimmune diseases, including IBD. It can block the downstream signaling pathway mediated by the GPCR, inhibit the migration and proliferation of various immune cells (such as monocytes/macrophages, helper T cells, etc.) to the inflammatory lesions, completely clear the inflammatory cells at the lesion site of autoimmune diseases, reduce the expression of pro-inflammatory cytokines, and effectively alleviate the progression of autoimmune diseases. IPG11406 has excellent physicochemical properties, high activity, good target specificity, and a wide safety window. It has demonstrated dose-dependent significant efficacy in preclinical studies of various autoimmune diseases, including systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease, and rheumatoid arthritis, with effective doses as low as 0.1 mg/kg. Following the completion of Phase I clinical trials as advised by the FDA, we will submit applications for Phase II clinical trials for other autoimmune diseases. Compared to marketed drugs such as adalimumab, vedolizumab, ustekinumab, and tofacitinib, IPG11406 has significant advantages in terms of safety, efficacy, and durability, making it a disease-modifying drug. So far, no other antagonist targeting the same pathway has entered the clinical trial stage, highlighting Immunophage's position globally.

Related news