MRM Health Starts Clinical Trial with Next-Generation Optimized Consortium Therapeutic MH002 in Pouchitis
MRM Health, a clinical-stage biopharmaceutical company developing next-generation live microbiome consortia therapeutics, announced today that they have received regulatory approval from the Federal Agency for Medicines and Health Products (FAMHP) in Belgium to start a Phase 2 trial with the novel next-generation optimized consortium therapy, MH002, in patients with Pouchitis.
MH002 is the first, rationally designed, consortium therapy, in which key disease-driving mechanisms guide therapeutic microbial strain selection, to enter clinical development in Pouchitis. Pouchitis (inflammation of the surgically constructed pouch after colectomy) is the most prominent complication after surgical removal of the large bowel (colectomy) that is performed as a last resort treatment in Ulcerative Colitis (UC). Pouchitis occurs in up to 50% of these patients within 1-2 years after surgery. Disease mechanisms include impaired gut wall barrier function linked to gut microbiome dysbiosis, translocation of microbial products and resulting immune cell activation, leading to chronic inflammation in the gut wall. To date, no registered oral therapeutics are available for Pouchitis, resulting in a significant unmet need for patients suffering from this highly debilitating, yet understudied rare disease indication.
Developed through MRM Health’s proprietary CORAL® Technology, MH002 consists of 6 well-characterized commensal strains that are optimized to form a synergistic microecosystem driving differentiated potency, resiliency, and engraftment. Combining rational selection of disease-modifying strains with consortium optimization to ensure live delivery, engraftment, and durability is expected to result in greater efficacy than conventional microbiome therapeutics. MH002 is produced using MRM Health’s breakthrough scalable, robust, and standardized cGMP manufacturing platform, overcoming past microbiome challenges in manufacturing multi-strain consortia of uniform composition. The standardized CORAL® platform allows the manufacturing of complete consortia as a single drug substance, expected to provide both key regulatory and patient compliance advantages.
Preclinical studies in inflammatory bowel disease (IBD) models showed that MH002 has an excellent safety profile, repairs gut microbiome dysbiosis, heals the dysfunctional intestinal barrier, and restores immune homeostasis with its differentiated mechanism targeting multiple key disease pathways. MH002 is currently assessed in a Phase 1b/2a study in patients with mild-to-moderate UC. The product’s disease-modifying mechanism is anticipated to induce remission in IBD via immunomodulation, rather than immunosuppression, resulting in superior safety with no elevated risks associated with reduced immune system functioning.
MRM Health’s Phase 2 study in Pouchitis is a multi-center, open label trial which will enrol up to 20 acute Pouchitis patients. The trial is designed to evaluate safety, mechanistic effects, and efficacy of MH002 on disease activity (EUDRACT Number: 2021-006656-14).
“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. Séverine Vermeire (MD, PhD), IBD expert at the Gastroenterology Department of the University Hospitals Leuven, Belgium, and coordinating investigator of the trial.
“This approval is another major step forward for MRM Health, as it allows to initiate a second clinical program and to further develop our rationally designed bacterial consortia therapeutic MH002 towards patients with IBD and beyond,” said Sam Possemiers (PhD), CEO and Co-Founder of MRM Health.
About MRM Health
MRM Health NV, Ghent, Belgium, is a biopharmaceutical company focused on the development of next-generation optimized consortium therapeutics based on the human microbiome. The company has built a diversified pipeline with its proprietary CORAL® platform to design, optimize, and manufacture bacterial consortia as single drug substance. Its most advanced program MH002 is an optimized consortium of 6 rationally-selected and well-characterized commensal strains. MH002 is currently being studied in two Phase 1b/2a studies in patients with mild-to-moderate Ulcerative Colitis and acute Pouchitis, respectively. Additional pipeline development includes a preclinical program in Parkinson’s disease, preclinical programs in Type 2 Diabetes and in NAFLD (both partnered with IFF Nutrition Biosciences, previously DuPont), and a discovery program in autoimmune disease, including spondyloarthritis.
MRM Health’s differentiating CORAL® platform utilizes a bioinformatics-guided in-human discovery engine combined with a breakthrough in optimization and manufacturing of consortia as single drug substance. The proprietary consortia optimization technology allows to develop next-generation consortia therapeutics with faster onset-of-action and increased potency and robustness. The breakthrough scalable, robust, and standardized cGMP-compliant consortia manufacturing technology allows to manufacture complete therapeutic consortia as a single drug substance in a single manufacturing process which strongly surpasses existing approaches in speed, reduced complexity, increased robustness and lower cost.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
For further information please contact:
Dr Sam Possemiers – CEO
Christiane Verhaegen – CFO
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Feeling ’22: Mary Kay Inc. Announces Awards, Milestones, and Accomplishments From First Half of the Year28.7.2022 20:02:00 EEST | Press release
Mary Kay Inc. is feeling ’22. Throughout the first half of the year, the iconic global entrepreneurship company has furthered its innovations in skin science, continued its social impact efforts, and garnered several prestigious awards for its business and leadership. It’s a thing of beauty—and the nearly 60-year-old brand is just getting started. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220728005228/en/ Mary Kay logo (Graphic: Mary Kay Inc.) 2022 AWARDS & HIGHLIGHTS 30 total awards for business excellence, social impact and sustainability 10 employer awards recognizing Mary Kay as a great place to work and for operational excellence 7 awards for Mary Kay’s c-suite and senior leadership 17 self-released reports reinforcing Mary Kay’s operational and philanthropic efforts supporting its sustainability commitments for its Enriching Lives Today for a Sustainable Tomorrow strategy 3 mentions in annual reports from social i
Asaf Ashkenazi Named CEO of Verimatrix28.7.2022 19:00:00 EEST | Press release
Regulatory News: Verimatrix (Euronext Paris: VMX) (Paris:VMX), today announced the appointment of Asaf Ashkenazi as Chief Executive Officer effective Monday, August 1st, 2022. Amedeo D’Angelo, Chairman and Chief Executive Officer since 2015, remains Executive Chairman of Verimatrix effective the same day. Asaf Ashkenazi joined Verimatrix in 2018 and currently serves as Chief Operating Officer. He will lead the company’s ongoing business model transformation announced last year that focuses on recurring subscription-based revenue sources and new products. “This evolution and reinforcement of the Verimatrix governance structure aligns well with the company’s needs as we further the progression of our business model,” Amedeo D’Angelo said. “I look forward to working closely with Asaf in his newly expanded role as CEO during this strategic development of Verimatrix.” Previously leading the company’s R&D, product, sales and marketing operations, Asaf Ashkenazi will continue to harness his d
GUESS Heads to Granada for the 2022 Fall/Winter Advertising Campaign28.7.2022 18:00:00 EEST | Press release
The new GUESS Fall-Winter 2022 advertising campaign sees the brand off to explore the history-steeped streets of Granada, Spain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220728005098/en/ GUESS Heads to Granada for the 2022 Fall/Winter Advertising Campaign (Photo: Business Wire) The FW22 campaign is immortalized through the lens of fashion photographer Tatiana Gerusova, under the guidance of GUESS?, Inc.’s Chief Creative Officer, Paul Marciano. The new campaign features a sizzling lineup: German-born, Polish fashion model Kim Dammer, Serbian model Nina Kostić, Spanish model Lidia Santos, Italian model Mario Ermito, and French model Xavier Grey. GUESS Women The campaign showcases an enticing array of GUESS pieces, highlighting must-have accessories and elevated animal and botanical prints. The collection brings a fresh and youthful breeze of contemporary color and style to grey winter days. Against the alluring continent
Innovaderm Bolsters European Presence With Two Newly-Established Operations Hubs (Spain & Poland)28.7.2022 17:00:00 EEST | Press release
Innovaderm announced today that its strategic European expansion initiative has reached a major milestone with the launch of two key centres of operations in Poland and Spain. Biotechnology and pharmaceutical companies can officially partner with the CRO’s team of experts in Europe to manage clinical trials in psoriasis, acne, atopic dermatitis and other dermatology indications. This includes adherence to stringent regulatory requirements, patient recruitment, site selection, clinical monitoring and protocol writing. “To date, we have successfully completed more than 500 clinical trials at 2,900 sites,” says Dave Selkirk, Innovaderm’s Chief Operating Officer. “The presence of two operations hubs in Europe will allow us to go one step further and accelerate the development of promising therapies that have the potential to transform lives. As we look to the future, our goal is to continue supporting innovation in research and the increasing number of patients with skin conditions worldwi
Echosens Partners with World Hepatitis Alliance on World Hepatitis Day, July 28, Urges Importance of Testing and Treatment28.7.2022 16:07:00 EEST | Press release
Echosens, a high-technology company offering liver diagnostic solutions, establishes its support of World Hepatitis Day (WHD), July 28 by partnering with the World Hepatitis Alliance as a bronze sponsor. The commemoration calls for greater awareness of the 357 million people who live with viral hepatitis but are unaware of it. The campaign’s theme “I can’t wait” highlights the need to accelerate the fight against viral hepatitis and the importance of testing and treatment for the real people who need it. “Echosens recognizes that every 30 seconds, someone in the world dies from a hepatitis-related illness, and we join hands with organizations throughout the world to advance increased vigilance around liver health,” says Dominque Legros, Echosens Group CEO. “It is gratifying to see that this year's theme for World Hepatitis Day aligns with our mission for early detection that can result in more effective intervention, treatment and better outcomes.” Viral hepatitis is an inflammation of
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom