A New Hope for Colitis: Microbiome Pill Advances to Key FDA Trial

GHENT, Belgium – January 09, 2026

Belgian biopharmaceutical company MRM Health has received a critical green light from the U.S. Food and Drug Administration (FDA) to advance its novel ulcerative colitis treatment, MH002. The clearance of its Investigational New Drug (IND) application paves the way for a large-scale Phase 2b clinical trial, marking a significant milestone for a new class of therapies that leverage the gut microbiome to combat chronic inflammatory diseases.

The upcoming trial, dubbed STARFISH-UC, will evaluate MH002 in patients with mild-to-moderate ulcerative colitis (UC), a debilitating form of inflammatory bowel disease (IBD) affecting millions worldwide. This development positions MH002 as a potential frontrunner among next-generation Live Biotherapeutic Products (LBPs), offering the promise of a targeted, oral treatment without the systemic side effects of many current medications.

A New Frontier in IBD Treatment

For decades, the standard of care for mild-to-moderate UC has centered on 5-aminosalicylates (5-ASA), which act directly on the inflamed colon lining. However, a substantial number of patients either fail to respond to these drugs or see their effectiveness wane over time, leaving them to face treatment with corticosteroids or more potent immunosuppressants. While biologics and other advanced therapies can be effective, they often work by systemically suppressing the immune system, which can increase the risk of infections and other complications.

MRM Health is pursuing a fundamentally different approach. Instead of suppressing the immune response, MH002 is designed to restore it. Described as a rationally designed live microbial consortium, the drug is a precisely formulated oral capsule containing six specific, well-characterized commensal bacterial strains. These strains were selected to work synergistically to address the underlying drivers of the disease, aiming to re-establish a healthy gut environment and promote mucosal healing.

This innovative therapy is the product of MRM Health's proprietary CORAL® platform, a technology that enables the company to design and manufacture a complete consortium of bacteria as a single, consistent drug substance. This approach overcomes a major hurdle in microbiome therapy development: the difficulty of producing complex, multi-strain products at a commercial scale with consistent quality, potentially offering a more reliable and cost-effective solution than earlier-generation microbiome treatments.

Building on Promising Early Results

The FDA's decision to grant IND clearance was based on a robust foundation of promising preclinical and clinical data. A previous Phase 2a trial in 45 UC patients across Europe provided compelling early evidence of both the safety and efficacy of MH002.

In that eight-week study, 18% of patients receiving MH002 achieved clinical remission, compared to zero percent in the placebo group. The treatment also demonstrated a significant anti-inflammatory effect, with patients on MH002 showing a 42% median reduction in fecal calprotectin—a key biomarker for bowel inflammation—while the placebo group saw only an 18% decrease. Furthermore, endoscopic assessments indicated a 17% significant improvement in mucosal healing over placebo.

Crucially, the therapy was well-tolerated. The rate of treatment-emergent adverse events was lower in the MH002 group (35%) than in the placebo group (57%), with no adverse reactions attributed to the drug itself. This strong safety profile was achieved without the need for vancomycin preconditioning, an antibiotic treatment sometimes used in other LBP trials to clear the existing gut microbiome, which can carry its own risks. The company also reported positive results from a separate open-label study in acute pouchitis, another inflammatory condition, suggesting the therapeutic potential of MH002 may extend to other IBD-related indications.

The Patient Perspective and Unmet Needs

For individuals living with ulcerative colitis, the daily reality can be a struggle against symptoms like abdominal pain, fatigue, and persistent, urgent bowel movements that severely impact their quality of life. The search for a treatment that is both effective and sustainable is a constant challenge. Many patients find themselves caught in a cycle of treatments that either provide incomplete relief or come with a heavy burden of side effects.

"There is a clear and urgent need for new therapies for our patients with mild-to-moderate UC who have an inadequate response to first-line agents," commented one gastroenterologist not involved with the study. "The ideal treatment would not only induce and maintain remission but do so with a favorable safety profile that avoids systemic immunosuppression. A convenient oral therapy that restores gut health from within would be a transformative addition to our treatment toolkit."

MH002 aims to be that solution. By offering a "one-pill," immune-sparing approach, MRM Health hopes to provide an effective option for patients who are not adequately controlled by 5-ASA drugs, potentially preventing or delaying the need for more aggressive, system-wide immunosuppressive therapies.

Strategic Backing and a Competitive Landscape

The advancement of MH002 is bolstered by strong financial and strategic confidence in MRM Health's platform. In September 2025, the company successfully closed a €55 million Series B financing round. The round was led by French pharmaceutical group Biocodex and German-based ATHOS, with participation from new and existing investors. This infusion of capital in a challenging biotech market underscores a belief in the company’s science and its potential to become a leader in the microbiome space.

The funds are primarily dedicated to advancing MH002 through its pivotal clinical trials. MRM Health is not alone in this emerging field; other companies, such as Microbiotica with its MB310 candidate, are also developing consortium-based therapies for UC. However, with its Phase 2b trial now cleared to proceed, MH002 is among the most clinically advanced rationally designed LBPs in development for IBD.

"Receiving IND clearance from the FDA is a testament to MH002’s robust clinical foundation and its potential to transform the lives of those living with UC," stated Sam Possemiers, CEO of MRM Health, in a recent announcement. "The upcoming STARFISH-UC study is a critical next step in our mission to deliver a convenient, immune-sparing, one-pill solution for IBD patients."

The STARFISH-UC trial is a randomized, double-blind, placebo-controlled study that will enroll approximately 204 patients across Europe and the United States. It will feature a 12-week induction phase followed by a 40-week open-label extension, designed to confirm the promising signals from earlier studies. With patient enrollment expected to begin in mid-2026, the results of this trial will be closely watched by patients, clinicians, and investors alike, as they could herald a new era in the management of inflammatory bowel disease.