GHENT, Belgium--(뉴스와이어)--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 www.mrmhealth.com.

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 www.nimblesci.com.

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.

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