Immunobiome's 'IMB002' Receives Phase 1 Clinical Approval... "Accelerating Therapeutic Development"

Microbiome-based new drug developer Immunobiome is set to officially begin domestic clinical trials.

On the 21st, Immunobiome announced that it received approval from the Ministry of Food and Drug Safety for the phase 1 clinical trial application (IND) of 'IMB002,' a new drug candidate for inflammatory bowel disease (IBD) and intractable autoimmune diseases.

In this phase 1 clinical trial, IMB002 will be administered to healthy adults to verify changes in gut microbiota composition and safety. Immunobiome aims to complete the phase 1 trial of IMB002 within next year and proceed with multinational phase 2 clinical trials.

The company plans to gradually expand the indications of IMB002 based on its anti-inflammatory mechanism of action to autoimmune diseases and rare diseases. For rheumatoid arthritis (RA), the IND submission is scheduled for the fourth quarter in accordance with the research progress.

IMB002 works by activating dendritic cells (DC) present in the gut and inducing the differentiation of immune regulatory T cells to suppress inflammatory responses. Immunobiome confirmed in preclinical studies the alleviation of inflammatory bowel disease symptoms, reduction of intestinal tissue damage compared to control groups, decrease in inflammatory cytokines, and expression of genes related to intestinal epithelial tissue recovery. Currently, new drugs targeting inflammatory bowel disease, RA, and rare diseases are under development.

A company representative stated, "Starting with this domestic clinical trial, we will also make thorough preparations for global clinical trials," adding, "We will prove the safety and efficacy of IMB002 and develop the first microbiome therapy in Korea." They further added, "We plan to complete the phase 1 clinical trial of IMB002 within next year and actively pursue an IPO for KOSDAQ listing."

Meanwhile, Immunobiome is developing treatments for intractable diseases through its proprietary Avatiome platform. Avatiome combines advanced technologies such as germ-free and humanized mouse models and AI-based prediction to derive candidate substances, elucidate mechanisms of action (MoA), and enhance clinical trial design based on these findings.

Using the Avatiome platform, Immunobiome has discovered candidate substance IMB001 alongside IMB002, and is conducting research to develop various high-activity microbial consortia and candidate combination drugs to be administered together with them.

This content was produced with the assistance of AI translation services.