GHENT, BELGIUM--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.