MRM Health NV

GHENT, Belgium--(BUSINESS WIRE)-- MRM Health, a clinical-stage biopharmaceutical company, announced today that it has received regulatory and ethics committee approval to start an observational, cross-sectional clinical trial to study the role of the small intestinal microbiome in Parkinson’s Disease (PD) and to identify PD-specific microbial and metabolic fingerprints in small intestinal fluid and blood. The clinical research is being conducted in close collaboration with Nimble Science and the University of Calgary, Canada. The clinical study is expected to enroll up to 100 subjects, including an age-matched healthy volunteer cohort. The trial will run in Calgary Parkinson’s Research Initiative (CaPRI) with Dr. Davide Martino and is registered on Clinicaltrials.gov with number NCT06003608. MRM Health develops rationally-designed consortium therapeutics through its proprietary CORAL® technology, comprising well-characterized commensal strains, selected and optimized to tackle key disease-driving mechanisms with enhanced potency, resiliency, and engraftment. MRM Health’s breakthrough, scalable and standardized cGMP manufacturing platform enables the manufacturing of complete consortia as a single drug substance, which is designed to overcome historical limitations of microbiome therapy and establish a new standard for effective consortia therapeutics development. MRM Health recently obtained positive phase 2a clinical data with MH002 in Ulcerative Colitis and has an ongoing clinical study in Pouchitis. In addition to its clinical programs in Inflammatory Bowel Diseases and the program in Parkinson’s Disease, the Company has preclinical programs in autoimmune disorders and in metabolic diseases, being developed through a partnership with IFF Nutrition Biosciences. Sam Possemiers, Chief Executive Officer at MRM Health, said: “We are excited to collaborate with Nimble Science and the Calgary Parkinson’s Research Initiative on this project and to use the innovative SIMBA capsule to sample the small intestinal content. We expect that the data generated in this study will provide unique insights into the composition of the small intestinal microbiome, which is so far largely unexplored, and its connection to the pathophysiology of Parkinson’s Disease. It will feed into our existing program and enable us to fine-tune and accelerate the development of novel Live Biotherapeutic Products for the treatment of this progressive, neurodegenerative disease.” Dr. Davide Martino, from the Calgary Parkinson’s Research Initiative and Principal Investigator of the study, said: “There is a high unmet medical need for safe and effective treatments for this seriously debilitating disease, and novel therapeutic modalities will be very welcomed by patients and caregivers, especially if they are disease modifying. This observational study is expected to help generate novel hypotheses to potentially impact the pathophysiology of Parkinson’s Disease and provide disease modifying therapy.” Sabina Bruehlmann, Chief Executive Officer at Nimble Science Inc., said: “We are emboldened to use our Small Intestine MicroBiome Aspiration (SIMBA) system to gather more data in order to better understand the role of the microbiome in the small intestine of Parkinson’s Disease patients. Performing the study in collaboration with MRM Health will enable the integration of multi-omic data from the SIMBA capsule with additional ‘omics data.’” The SIMBA system is a single-use, ingestible passive capsule that allows for the non-invasive sampling of small intestinal contents. It is designed to open and absorb intestinal content after having passed the acid stomach environment and to mechanically seal before passing into the large bowel. It has distinct markers built in to allow radiographic tracking of its passage throughout the GI system. The SIMBA capsule was developed and validated by Nimble Science and has already shown its promise in retrieving specific small intestine material in previous studies. About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program, MH002, is in preparation for pivotal clinical development in Ulcerative Colitis, upon obtaining positive clinical results in a phase 2a clinical trial, and is being evaluated in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable, and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at . About Nimble Science Nimble Science is a digital health company delivering first-in-class at home capsule based small intestinal fluid biopsy and multi-omic microbiome data capabilities via its SIMBA™ GI Health platform. Nimble’s SIMBA™ capsule has been clinically validated to collect an uncontaminated sample from the deepest and previously inaccessible regions of the small intestine – housing one of the most bioactive and critical microbial environments. Nimble’s technology, ease of administration and actionable health data insights are unparalleled in comparison with competing solutions, and Nimble has been actively partnering with industry leaders around the world to empower breakthrough health innovation spanning pharmaceuticals, diagnostics and consumer health R&D programs. To learn more, please visit the website at . About Parkinson Disease Parkinson's disease is a progressive, irreversible brain disorder that causes unintended or uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination. Symptoms usually begin gradually and worsen over time. Current treatment aims to manage the symptoms and improve the quality of life for patients. Medications like levodopa and dopamine agonists can help alleviate motor symptoms by replenishing dopamine levels in the brain. There is still a high remaining unmet need for new therapies and interventions to improve the management of Parkinson's disease and enhance the overall well-being of affected individuals. No disease-modifying treatment is available to date. View source version on businesswire.com: Contacts MRM Health Dr Sam Possemiers – CEO Christiane Verhaegen – CFO Tel: +32.9.277.08.50 info@mrmhealth.com Stern Investor Relations Stephanie Ascher Stephanie.ascher@sternir.com +1 212-362-1200 Source: MRM Health View this news release online at:

MRM Health’s microbiome consortium therapy for ulcerative colitis has shown promise in a Phase IIa trial, triggering plans for late-stage development and potential partnerships. The Belgian biotech’s study set the treatment, dubbed MH002, against placebo in 45 people with mild-to-moderate UC. MH002 produced a 12% improvement in the Mayo Endoscopic Severity score, while the score worsened by 5% with placebo (p=0.05). The treatment also hit significance in the endpoint of stool consistency improvement after two weeks (p=0.006). You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

Primary endpoint reached: safe and well tolerated, no evidence of adverse reactions related to MH002 when administered for 16 weeks Initial efficacy observed in clinically relevant parameters, including 17% significant improvement over placebo at week 8 in centrally-assessed Mayo Endoscopic Severity score (p=0.05) and significant improvement of stool consistency seen as from 2 weeks of treatment (p=0.006) At a mechanistic level, anti-inflammatory effects demonstrated by 42% decrease in median fecal calprotectin (a bowel inflammation marker) relative to placebo (18%) Full analysis and presentation of the data by end 2023; Progression to Phase 2/3 development initiated MH002 is currently the most advanced rationally-designed microbiome consortium therapy in the UC field GHENT, Belgium--(BUSINESS WIRE)-- MRM Health NV, a clinical-stage biopharmaceutical company focused on developing next-generation live microbiome consortia therapeutics, today reports positive topline results from its Phase 2a clinical trial with MH002 in mild-to-moderate Ulcerative Colitis (UC). MRM Health’s MH002-UC-201 study was a multi-center, double-blind, randomized, placebo-controlled trial in 45 UC patients at multiple clinical sites in Belgium, Poland and Czech Republic. The study was designed to evaluate safety (primary endpoint), initial efficacy and mechanistic effects of MH002 over eight weeks, with a further eight-week extension period. More information about the trial is available at clinicaltrialsregister.eu. The primary endpoint was met with an excellent safety pro 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%. 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). As opposed to previous trials with other live biotherapeutics in UC, this study was performed successfully without vancomycin preconditioning. At a mechanistic level, anti-inflammatory effect was demonstrated with 42% decrease in median fecal calprotectin (a clinically relevant bowel inflammation marker) compared to 18% in placebo at week 8. “These early results indicate that MH002 is safe and well tolerated by patients, and has potential efficacy in mild-to-moderate UC patients who have not responded sufficiently to first-line treatment,” commented Séverine Vermeire, coordinating investigator of study MH002-UC-201 and Professor of Medicine at the KU Leuven, Belgium. “There is a significant absence of treatments for UC patients, particularly in this population, so I look forward to conducting the full analysis of the data and following MH002’s progression through the clinic.” Bruce Sands, Professor of Medicine at the Icahn School of Medicine at Mount Sinai, New York and paid consultant to MRM Health, 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.” 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. Ludo Haazen, Chief Medical Officer at MRM Health, added: “This first clinical study enables us to move forward with our clinical programme in UC. We are excited to see that MH002 differentiated in this early study significantly and consistently from placebo in clinically relevant parameters, including the centrally assessed MES, which was supported by the mechanistic parameters we have measured.” MH002 is currently the most advanced rationally-designed consortium therapy in the UC field. It was developed through MRM Health’s proprietary CORAL® Technology and comprises six well-characterized commensal strains, selected and optimized to tackle key disease-driving mechanisms with enhanced potency, resiliency, and engraftment. Production is via MRM Health’s breakthrough scalable and standardized cGMP manufacturing platform, allowing the manufacturing of complete consortia as a single drug substance. The ability of CORAL® to enable scalable, cost-effective manufacturing of complete optimized consortia in a single process is expected to provide both key regulatory and patient compliance advantages. In addition to the recently completed UC trial, MH002 is being tested in an ongoing multi-center, open label Phase 2 study enrolling patients with acute Pouchitis, a rare disease with high unmet medical need. Sam Possemiers, Chief Executive Officer at MRM Health, said: “These early clinical data are very important for the Company, since they further validate our proprietary CORAL® technology which underlies our portfolio of live biotherapeutic products. The data enables us to take the next steps in our business strategy where we will be engaging with regulatory agencies in all territories and potential new partners as well as driving forward the rest of our development portfolio.” -Ends- About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis, upon obtaining positive clinical results in a phase 2a clinical trial, and is being evaluated in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at . About IBD and UC Ulcerative colitis (UC) is a chronic, autoimmune, inflammatory bowel disease (IBD) characterized by mucosal inflammation of the colon resulting in debilitating diarrhea, abdominal pain, and rectal bleeding with significant impact on quality of life of patients and an increased risk of colorectal cancer development. Whereas many treatments exist and are in development for moderate-to-severe UC, only very limited options are available for mild-to-moderate disease. Current therapies have a merely symptomatic anti-inflammatory and/or an immunosuppressant effect and in many cases fail to induce enduring remission and/or cause potentially severe adverse events. These treatments also do not tackle what is considered as one of the core problems of UC, the overall poverty of microorganisms present in the gut of UC patients, also termed gut dysbiosis. MH002 is designed to enrich the gut microbiome of UC patients and thereby tackle what is considered a root cause of the disease. View source version on businesswire.com: Contacts For further information please contact: MRM Health Dr Sam Possemiers – CEO Christiane Verhaegen – CFO Tel: +32.9.277.08.50 info@mrmhealth.com Instinctif Partners (media) Melanie Toyne-Sewell Giulia Lasagni Tel: +44 207 457 2020 MRMHealth@instinctif.com Source: MRM Health NV View this news release online at: