Nanjing Immunophage Biomedical Co., Ltd. (“Immunophage”) today announced that its first-in-class drug candidate, EBI2 (GPR183) antagonist IPG11406, has achieved positive efficacy data and a favorable safety profile in a Phase 2a clinical trial for systemic lupus erythematosus with lupus nephritis. Based on this, the Company has planned to initiate and advance two randomized, double-blind, placebo-controlled studies: a Phase 2b study in lupus nephritis and a Phase 2 study in moderate to severe ulcerative colitis.
The Phase 2a trial in systemic lupus erythematosus with lupus nephritis was conducted at Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, with Professor Lingyun Sun, Vice President of Nanjing Drum Tower Hospital and Clinical Director of the Institute of Rheumatology and Immunology at Nanjing University, as the principal investigator. A total of 24 patients received IPG11406. The treatment period was 4 weeks, with the follow-up period of 4 weeks. In the Phase 2a trial, IPG11406 demonstrated favorable safety, tolerability, and efficacy.
About IPG11406
Autoimmune diseases are major chronic diseases driven by a breakdown of immune tolerance, sustained amplification of inflammation, and target organ damage, encompassing systemic lupus erythematosus, lupus nephritis, inflammatory bowel disease, multiple sclerosis, and others. These diseases are characterized by a prolonged course, high relapse rate, and high disability; patients often require lifelong treatment, constituting a heavy societal and medical burden.
IPG11406 is the first and only small molecule EBI2 antagonist in clinical development globally. EBI2 is expressed on various immune cells, including B and T cells. In autoimmune disease, EBI2 plays a dual role: it mediates the migration and aberrant activation of B and T cells in lymph nodes, initiating the autoimmune cascade; and it drives the infiltration of pathogenic immune cells into target tissues, causing tissue inflammation and damage. By selectively blocking EBI2 signaling, IPG11406 prevents aberrant B and T cell activation and differentiation upstream in lymph nodes, and inhibits the migration and proliferation of multiple immune cell types downstream in target organs, thereby clearing inflammatory cells, reducing pro-inflammatory cytokine expression, and slowing disease progression, representing a “disease-modifying” therapeutic strategy.
A randomized, double-blind, placebo-controlled Phase 2b study in patients with lupus nephritis is currently advancing rapidly at Nanjing Drum Tower Hospital, aiming to further validate the efficacy and safety of IPG11406.
Concurrently, another randomized, double-blind, placebo-controlled Phase 2 study in moderate to severe ulcerative colitis is being advanced, with Professor Hong Yang of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, as the principal investigator, aiming to evaluate the efficacy and safety of IPG11406 in ulcerative colitis.
Executive Quote
Dr. Guohuang Fan, Founder, Chairman, and CEO of Immunophage, said: “Autoimmune disease drug development is undergoing a profound paradigm shift from ‘broad immunosuppression’ to ‘precise modulation of key pathological pathways.’ The Phase 2a data of IPG11406 validate our core scientific hypothesis — by targeting EBI2 to precisely regulate the migration of pathogenic immune cells, rather than simply suppressing the entire immune system, patients may achieve deep disease remission and long-term disease control. The Phase 2b study in lupus nephritis and the Phase 2 study in ulcerative colitis are now in full acceleration. We look forward to this oral small molecule-based strategy of precise immune cell migration modulation offering patients with autoimmune diseases an innovative treatment option that can be used long-term to fundamentally prevent organ damage.”
About Immunophage
Nanjing Immunophage Biomedical Co., Ltd. (“Immunophage”) was founded in 2016. It is a clinical-stage biopharmaceutical company with a base in China and a global outlook, dedicated to developing first-in-class new drugs for autoimmune diseases, oncological diseases, and neurodegenerative diseases. Immunophage has obtained more than 40 invention patents. There are 7 pipeline programs, with novel drug candidates including IPG11406, IPG1094, IPG7236, IPG8294 and others now in clinical development. The Company is a National High-Tech Enterprise, a Jiangsu Provincial Emerging Enterprise, and a Nanjing Municipal Foreign-Funded R&D Center. It has received key support from the Jiangsu Provincial “Innovation and Entrepreneurship Program,” has been recognized as a “Jiangsu Provincial Potential Unicorn Enterprise,” honored as a “Most Valuable Investment Enterprise in China,” and consistently listed among the Top 100 Innovative Enterprises in the Chinese biopharmaceutical industry.
