Ileitis

AMSTERDAM, Feb. 21, 2024 /PRNewswire/ -- Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced topline results demonstrating the pharmacokinetic (PK) and pharmacodynamics (PD) comparability of its biosimilar candidate PB016 to its reference drug, Entyvio®* (vedolizumab). Results came from a single-dose, randomized, double-blind, 3-arm parallel-group study assessing the PK/PD and immunogenicity for PB016 compared to Entyvio®* after intravenous administration in 120 healthy subjects. PB016 was found to show comparability to Entyvio®* in all investigated PK and PD parameters, with no immunogenicity or safety imbalances to the reference drug. "We are excited to share new data showing the PK/PD comparability of our investigational vedolizumab biosimilar to its reference drug. The results confirm its potential as a more affordable future option for 3.5 million patients suffering from inflammatory bowel diseases in Europe and in the US. As the frontrunner among biosimilar competitors, PB016 targets a market with over $5.3 billion in annual Entyvio®* sales, expected to grow to over $7 billion by 2030", said Konstantin Matentzoglu, member of the Supervisory Board and the executive management, Polpharma Biologics Group. "With two biosimilars from our pipeline already partnered with highly reputable companies, we are proud that PB016 is the next Polpharma Biologics therapy which has entered late-stage development. Our scientists have developed it from cell line development to full-scale manufacturing in-house, an optimal position for securing future commercial partnerships for this asset." Polpharma Biologics is currently conducting a global clinical safety & efficacy study in patients with ulcerative colitis (UC) to provide further evidence on the efficacy, safety and immunogenicity of PB016, as compared to the reference drug. Vedolizumab is a monoclonal antibody that targets the α4β7 integrin, a protein found on gut homing T helper lymphocytes, reducing gastrointestinal inflammation.[1] It is approved in the US and Europe as a treatment for moderate-to-severe cases of UC and Crohn's disease[2],[3] - the two most common forms of inflammatory bowel disease (IBD) - and additionally for pouchitis in Europe.3 Vedolizumab is approved in over 70 countries worldwide, including Japan, Canada, and Australia, though its approved uses may vary. These chronic bowel conditions affect over 3.5 million people in Europe and the US, often significantly impacting patients' daily functioning and quality of life.[4] Factors like genetics and increasing urbanization may be contributing to growing prevalence of these diseases.[5] Polpharma Biologics is focused on broadening access to biological medicines used to treat some of the world's most impactful diseases across neurology, immunology, and ophthalmology. The company is at the forefront of the next wave in biopharma, leveraging its knowledge, capabilities, and footprint to develop its robust pipeline of more than seven biosimilars in early-late-stage development. *Entyvio® is a trademark of Takeda Pharmaceutical Company Limited. About Polpharma Biologics Polpharma Biologics is an international biotechnology company, with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Polpharma Biologics develops biosimilar therapies to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production, preparing drugs for future commercial partnerships with global pharmaceutical organizations. Under partnerships agreements, the company manufactures two approved biosimilars from its pipeline; ranibizumab and natalizumab. With its cell line development center in The Netherlands, and two centers of development and manufacturing in Poland, Polpharma Biologics creates development opportunities for biotechnology specialists. Learn more at . Disclaimer This press release is issued from Polpharma Biologics Group B.V. and is intended to provide worldwide information about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group B.V. is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks, and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either expressed or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy. References [1] National Institute for Health and Care Excellence. Available at: . Last accessed February 2024 [2] Entyvio (vedolizumab) US Prescribing Information. Available at: . Last accessed February 2024 [3] Entyvio (vedolizumab) SPC. Available at: . Last accessed February 2024 [4] Jairath V, Feagan B G. Lancet. 2019; DOI:(19)30358-9 [5] GlobalData Epidemiology Forecast to 2031 SOURCE Polpharma Biologics

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:

FRIDAY, Jan. 19, 2024 -- In a clinical practice guideline issued by the American Gastroenterological Association (AGA) and published in the January issue of Gastroenterology, recommendations are presented for the management of pouchitis . Edward L. Barnes, M.D., M.P.H., from the University of North Carolina at Chapel Hill, and colleagues developed recommendations for the prevention and treatment of pouchitis and cuffitis to support practitioners in their management of these conditions. The guideline panel made nine conditional recommendations. The AGA suggests using antibiotics for treatment of pouchitis in patients with ulcerative colitis who have undergone ileal pouch-anal anastomosis and experience intermittent symptoms of pouchitis. Probiotics are suggested for the prevention of recurrent pouchitis in patients who experience recurrent episodes of pouchitis that respond to antibiotics. Chronic antibiotic therapy is suggested to prevent recurrent pouchitis in patients who experience recurrent pouchitis that responds to antibiotics but relapses after stopping antibiotics; however, advanced immunosuppressive therapies approved for treatment of inflammatory bowel disease are suggested for patients who are intolerant to antibiotics or who are concerned about the risks of long-term antibiotic therapy. Advanced immunosuppressive therapies are also suggested for patients with recurrent pouchitis with inadequate response to antibiotics; corticosteroids can also be considered for these patients. "As providers we struggle to get insurance approval for medications to treat pouchitis, because it has not been a well-defined or recognized entity," coauthor Siddharth Singh, M.D., from the University of California San Diego in La Jolla, said in a statement. "Our intention with this guideline is to help improve access for patients and providers to use these advanced therapies." Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.