MH002 / MRM Health - LARVOL DELTA

A SIX-STRAIN COMMENSAL BACTERIAL CONSORTIUM (MH002) ENHANCES ANASTOMOTIC HEALING IN A MURINE ANASTOMOTIC LEAKAGE MODEL (UEGW 2026) - "These findings demonstrate that MH002 improves anastomotic healing by reducing colonic inflammatory gene expression and reinforcing barrier function. Ongoing analyses of microbiota composition, fecal metabolomics and additional in vitro studies will be essential to understand the mechanisms underlying the beneficial effects of MH002."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CCL2 • MIP-2 • MMP9 • TJP1

DESIGN OF A CONFIRMATORY PHASE 2 TRIAL TO ASSESS MH002, AN OPTIMIZED LIVE BIOTHERAPEUTIC PRODUCT, VERSUS PLACEBO IN MILD-TO-MODERATE ULCERATIVE COLITIS (UEGW 2026) - "Post-hoc analysis of the first clinical trial suggests that a treatment period longer than 8 wks may be warranted to reach more pronounced microbiome shifts as well as enabling patients with MES=3 to achieve clinical remission. These insights led to the design of the STARFISH-UC study as a 12-week induction study, followed by a 40-week open-label extension phase. Results from this ongoing trial should enable to confirm the promising benefit/risk profile observed in a first study."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MRM Health Strengthens Board with Michel Detheux as Chairman and Hans-Jürgen Wörle as Independent Director as MH002 Advances Through Phase 2b (Businesswire) - "Werner played an important role during a period of significant growth, including successful financing rounds and the continued advancement of MH002 toward late-stage clinical development."

Clinical • Trial status • Ulcerative Colitis

MRM Health’s Lead Candidate MH002 Granted Fast Track Designation by U.S. FDA for the Treatment of Mild-to-Moderate Ulcerative Colitis (Businesswire) - "The designation was supported by results from a completed Phase 2a clinical trial in mild-to-moderate UC....MRM Health will be presenting at upcoming Digestive Disease Week (DDW) 2026, taking place from May 2nd – May 5th in Chicago, IL, USA."

Fast track • P2a data • Ulcerative Colitis

StarFish-UC: Confirmatory Clinical Study in Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: MRM Health NV | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MH002, an optimized live biotherapeutic product, for the treatment of mild to moderate Ulcerative Colitis: exploratory insights from a first-in-disease, double-blind, randomized clinical trial (ECCO-IBD 2026) - "Also, absence of a vancomycin microbiome depletion allows to study the general microbiome recovery in patients. These data allow optimization of the next clinical study protocol."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MRM Health…announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its lead program MH002 (Businesswire) - "This enables the initiation of the STARFISH-UC Phase 2b clinical trial in patients with mild-to-moderate ulcerative colitis, marking a significant step forward in the development of next-generation therapies for inflammatory bowel diseases (IBD)."

IND • Trial status • Ulcerative Colitis

StarFish-UC: Confirmatory Clinical Study in Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=204 | Not yet recruiting | Sponsor: MRM Health NV

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MRM Health Raises €55 Million Series B to Advance Best-in-Class Microbiome-Based Biotherapeutic Product Pipeline (Businesswire) - "Funding to support Phase 2b trial with MRM Health’s lead program MH002 in ulcerative colitis and advance two additional programs to IND approval; Strategic partnership with Biocodex in biotherapeutics development and manufacturing adds significant non-dilutive funding in addition to the Series B financing; Investment fuels expansion of proprietary CORAL platform and pipeline."

Financing • Ulcerative Colitis

MH002, a Novel Butyrate-Producing Consortium of Six Commensal Bacterial Strains Has Immune-Modulatory and Mucosal-Healing Properties. (PubMed, Int J Mol Sci) - "Finally, MH002 protected mice and rats from chemically induced colitis. Altogether, results showed that MH002 presents a novel therapeutic avenue for the treatment of IBD."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

MH002, AN OPTIMIZED LIVE BIOTHERAPEUTIC PRODUCT, FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASES, HAS MODE-OF-ACTIONS LINKED TO RESTORATION OF INTESTINAL DYSBIOSIS, MUCOSAL INTEGRITY, AND IMMUNE HOMEOSTASIS (UEGW 2024) - "These observations suggest that MH002-treated patients had positive changes in gut microbial diversity and overall microbiome composition, coinciding with clinical improvement and downregulation of genes involved in immune and inflammatory responses, antimicrobial defense mechanisms, and resulting in dampening of immune cells’ activity, and associated with UC. MH002, therefore, represents a promising new treatment for mild-to-moderate UC patients insufficiently controlled with 5-ASA. These results warrant further development in a phase 2/3 study."

Dysbiosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • REG1A • REG3A • SAA1 • SAA2 • SAA4

SAFETY AND TOLERABILITY OF MH002, A LIVE BIOTHERAPEUTIC PRODUCT, IN INFLAMMATORY BOWEL DISEASE: SUMMARY OF DATA FROM TWO PHASE 2 CLINICAL TRIALS (UEGW 2024) - "MH002 was well tolerated and safe in the first-in-disease phase 2 clinical trials conducted in UC and PC. MH002 may exhibit a particularly favourable safety profile if these results are confirmed in larger, late-stage clinical studies."

Clinical • P2 data • Cardiovascular • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders • Pain • Pulmonary Arterial Hypertension • Septic Shock • Type 2 Diabetes Mellitus • Ulcerative Colitis

MH002, AN OPTIMIZED LIVE BIOTHERAPEUTIC PRODUCT, PROVIDES EFFICACY IN ACUTE POUCHITIS: RESULTS FROM A PILOT STUDY (UEGW 2024) - P2 | "In this exploratory study in patients with acute pouchitis, 8-wk treatment with MH002 resulted in consistent and clinically meaningful improvements with a remission rate of 46% according to the mPDAI. These results warrant further development of MH002 in a phase 2/3 study."

Clinical • Gastrointestinal Disorder • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

SAFETY AND EFFICACY OF MH002, AN OPTIMIZED LIVE BIOTHERAPEUTIC PRODUCT, FOR THE TREATMENT OF MILD TO MODERATE ULCERATIVE COLITIS: A FIRST-IN-DISEASE, DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL (DDW 2024) - "MH002 was safe and well tolerated: a TEAE was reported in 11/31 (35%) patients with MH002 and in 8/14 (57%) with PBO. Most TEAEs were mild and unrelated to study treatment. Early discontinuations (7/45; 16%) occurred similarly in both groups."

Clinical • Late-breaking abstract • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MH002, AN OPTIMIZED LIVE BIOTHERAPEUTIC PRODUCT FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASES, HAS MODE-OF-ACTIONS LINKED TO RESTORATION OF INTESTINAL DYSBIOSIS, MUCOSAL INTEGRITY, AND IMMUNE HOMEOSTASIS (DDW 2024) - "In vitro administration of MH00 to patient-derived colonic microbiomes restored within 1d butyrate production and increased efficiency to improve epithelial barrier integrity modulate T cell-mediated immune responses and promote mucosal wound healing in in vitro cell cultures (Table 1). DSS intake induced a significant decrease in relative BW and an increase in DAI. A significant recovery (BW DAI stool consistency) was observed at Day11 for MH00 and 5-ASA."

Dysbiosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

MRM Health to Present Positive Clinical Data from MH002 in Ulcerative Colitis at Digestive Disease Week (DDW) (Businesswire) - P2a | N=45 | "MRM Health NV...announced it will present positive data for its lead asset, MH002, a live microbial consortium therapy for Inflammatory Bowel Diseases, in two oral presentations during the 2024 Digestive Disease Week (DDW) meeting, being held May 18-21, 2024 in Washington, D.C. at the Walter E. Washington Convention Center....Initial efficacy on disease activity was evidenced in clinically relevant parameters, including a 12% improvement in Mayo Endoscopic Severity (MES) score (p=0.05, 1-sided Wilcoxon rank sum test), while placebo worsened by 5%. Stool consistency significantly improved in the MH002 treatment group as from week 2 (p=0.006; 1-sided Student t-test). At the end of the eight-week period, 18% of subjects achieved clinical remission compared to 0% of the placebo group (Per-protocol analysis). In contrast to previous trials with other live biotherapeutics in UC, this study was performed successfully without vancomycin preconditioning."

P2a data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MRM Health Reports Safety and Positive Efficacy Data in Pouchitis in Phase 2a Clinical Study with MH002 (Businesswire) - P2 | N=14 | "MRM Health NV...reports positive topline results from its Phase 2a clinical trial with MH002 in the orphan disease indication Pouchitis....The trial met its primary objective with an excellent safety and tolerability at a fixed dose of 400mg per day over 8 weeks’ administration. Treatment-Emergent Adverse Events (TEAE) reported were predominantly mild and unrelated, and there was no evidence of adverse reactions related to MH002."

P2a data • Immunology • Inflammatory Bowel Disease

MH002, an optimized live biotherapeutic product, for the treatment of inflammatory bowel diseases, has mode-of-actions linked to restoration of intestinal dysbiosis, mucosal integrity, and immune homeostasis (ECCO-IBD 2024) - P1/2 | "Conclusion By restoring intestinal dysbiosis and epithelial integrity, and attenuating local inflammation, MH002 treatment should lead to lower disease activity and, ultimately, to clinical remission without immune suppression. Indeed, study MH002-UC-201 in mild-to-moderate UC was completed with favourable treatment effects (endoscopic improvement, faecal calprotectin normalization, improved stool consistency) and no safety concerns (Abstract Vermeire et al.; EudraCT 2020-004355-33)."

Dysbiosis • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Safety and efficacy of MH002, an optimized live biotherapeutic product, for the treatment of mild to moderate ulcerative colitis: a first-in-disease, double-blind, randomized clinical trial (ECCO-IBD 2024) - "MH002 therefore represents a promising new treatment for mild to moderate UC patients insufficiently controlled with 5‑ASA. These results warrant further development in a phase 2/3 study."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MRM Health Reports Positive Topline Results from Phase 2a Clinical Study with MH002 in Mild-to-Moderate Ulcerative Colitis (Businesswire) - "Bruce Sands...added: 'MH002's mechanism of action and anti-inflammatory effect in UC look very promising, with the potential of a highly favorable benefit/risk balance, pending larger confirmatory studies. These topline results also suggest that this formulation could have applications across a wider range of other inflammatory bowel disorders, including pouchitis, in which MH002 is also being tested.'"

Media quote • P2a data

MRM Health Reports Positive Topline Results from Phase 2a Clinical Study with MH002 in Mild-to-Moderate Ulcerative Colitis (Businesswire) - P2a | N=45 | "MRM Health NV...reports positive topline results from its Phase 2a clinical trial with MH002 in mild-to-moderate Ulcerative Colitis (UC)....The primary endpoint was met with an excellent safety profile and tolerance at a fixed dose of 400mg per day over 16 weeks administration. Treatment-Emergent Adverse Events (TEAE) were reported in 35% of patients allocated to MH002 treatment compared to 57% when treated with placebo and there was no evidence of adverse reactions related to MH002. Initial efficacy on disease activity was evidenced in clinically relevant parameters, including a 12% improvement in Mayo Endoscopic Severity (MES) score (p=0.05, 1-sided Wilcoxon rank sum test), while placebo worsened by 5%....Full analysis and presentation of the data is expected by the end of 2023. The Company has initiated to progress the program into Phase 2/3 development."

P2a data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MRM Health Completes Patient Recruitment in Ulcerative Colitis Study, Secures Financing and Provides Outlook for 2023 (Businesswire) - "Completed patient enrollment in its phase 2a trial in Ulcerative Colitis with next- generation live microbiome consortia therapeutic MH002, with topline results expected in Q3 2023. Has ongoing patient enrollment in its open-label phase 2 trial in the rare disease indication Acute Pouchitis....op-line data from Phase 2a trial with MH002 in Ulcerative Colitis in Q3 2023 and mechanistic readouts in Q4 2023; Initial data from open label Phase 2 trial with MH002 in Acute Pouchitis in Q4 2023."

Enrollment closed • P2 data • P2a data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MRM Health Starts Clinical Trial with Next-Generation Optimized Consortium Therapeutic MH002 in Pouchitis (Businesswire) - '"With no registered oral treatment available for Pouchitis, a strong medical need exists for an effective and safe new medicinal product for the treatment of this serious disease. With its differentiating mode-of-action, MH002 has a high potential to fill that need and may become a novel tool in the first-line treatment of Pouchitis,' said Prof. Severine Vermeire (MD, PhD)..."

Media quote

MRM Health to Present at the 6th Microbiome Movement Drug Development Europe Summit (GlobeNewswire) - "MRM Health...announced that it will present scientific data from its portfolio at the 6th Microbiome Movement Drug Development Europe Summit, resulting from its proprietary and unique CORAL™ platform technology...Regarding the ongoing Phase 1b/2a double-blind, randomized placebo-controlled trial with MH002 in Ulcerative Colitis, enrollment is progressing well and all trial sites in Belgium, Poland and Czech Republic are being initiated."

Enrollment status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MRM Health Announces First Patient Dosed with Next Generation Live Microbiome Consortia Therapeutic MH002 in Phase 1b/2a Study in Patients with Ulcerative Colitis (GlobeNewswire) - "MRM Health...announced that the first patient received MH002 in a phase 1b/2a multi-center clinical trial in mild-to-moderate Ulcerative Colitis. MH002 is MRM Health’s first clinical product candidate resulting from its proprietary and unique CORAL™ platform technology...MRM Health’s MH002-UC-201 study is a multi-center, double-blind, randomized, placebo-controlled trial in multiple clinical sites in Belgium, Poland and Czech Republic and will enrol 45 mild-to-moderate UC patients."

Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis