Ferring and Rebiotix to Present Landmark Data for Investigational Microbiota-based Live Biotherapeutic RBX2660 at Digestive Disease Week ® (DDW) 2021
Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today announced that Phase 3 data evaluating its investigational microbiota-based live biotherapeutic RBX2660 for reduction of recurrent Clostridioides difficile(C. difficile) infection will be presented as part of an invited talk at Digestive Disease Week® (DDW) 2021. The congress will take place virtually from May 21-23, 2021.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210513005129/en/
“These data are the pinnacle of a decade of ground-breaking research and development, driven by the goal of helping those who are experiencing the debilitating effects of recurrent C. difficile infection,” said Lee Jones, Founder, President and Chief Executive Officer of Rebiotix, a Ferring Company. “We’re striving to deliver innovative therapeutics to help people live better lives, and are proud to be pioneering a new category of scientifically-validated, microbiome-based therapeutics that are standardized for quality and safety. We’re looking forward to sharing this milestone data with the entire community at DDW.”
The clinical development program for RBX2660 is the largest and most robust ever conducted in the field of microbiome-based therapeutics, including six clinical trials enrolling more than 1,000 patients to date.
C. difficile infection is a serious and potentially deadly disease that impacts people across the globe. Declared a public health threat by the U.S. Centers for Disease Control and Prevention (CDC) requiring urgent and immediate action, C. difficile infection causes an estimated half a million illnesses and tens of thousands of deaths in the U.S. alone each year.1,2,3C. difficile infection recurs in up to 35% of cases after initial diagnosis4,5 and people who have had a recurrence are at significantly higher risk of further infections.6,7,8,9 Recurrent C. difficile infection (rCDI) is associated with disruptions to the gut microbiome, or “dysbiosis”. The current standard of care treatment for rCDI is antibiotics, which does not address the underlying dysbiosis or restore the gut microbiome.10
To further amplify the impact of this devastating disease, Ferring will also present an analysis of mortality rates and healthcare costs among Medicare patients with primary C. difficile infection and rCDI in cohorts of patients with and without sepsis. Sepsis, the body’s extreme response to an infection and a life-threatening medical emergency11, can be a complication of C. difficile infection.
The details of the three presentations are as follows:
Session Number: 2155
Session Title: Beyond FMT: A Pragmatic Approach to Microbiome Therapies: RBX2660 Study
Presenting Author: Christine Lee, MD, FRCPC, Clinical Professor, Department of Pathology and Laboratory Medicine, UBC Faculty of Medicine; Medical Microbiologist and Researcher, Island Health
EMBARGOED UNTIL PRESENTATION TIME: FRIDAY, MAY 21 AT 1:24 PM ET
Session Number: 6320
Poster Number: Sa611
Title: Interim Analysis of a Phase 3 Open-Label Study Indicates Safety and Efficacy of RBX2660, an Investigational Live Biotherapeutic, in a “Real-World” Population of Patients With Recurrent Clostridioides difficile Infection
Presenting Author: Colleen Kraft, MD, Associate Professor, Division of Infectious Diseases, Emory University School of Medicine
EMBARGOED UNTIL PRESENTATION TIME: SATURDAY, MAY 22 AT 12:15 PM ET
Session Number: 5345
Poster Number: Fr559
Title: A Real-World Comparison of Mortality, Healthcare Resource Utilization, and Cost Among Medicare Beneficiaries with Clostridioides difficile Infection With and Without Sepsis
Presenting Author: Alpesh Amin, MD, MBA, Thomas & Mary Cesario Chairman, Department of Medicine, Executive Director, Hospitalist Program, University of California – Irvine
EMBARGOED UNTIL PRESENTATION TIME: FRIDAY, MAY 21 AT 12:15 PM ET
DDW has made abstracts available on their website.
RBX2660 is a potential first-in-class microbiota-based live biotherapeutic being studied to deliver a broad consortium of diverse microbes to the gut to reduce recurrent C. difficile infection. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). The pivotal Phase 3 program builds on nearly a decade of research with robust clinical and microbiome data collected over six controlled clinical trials with more than 1,000 participants.
About the gut microbiome and C. difficile infection
The gut microbiome is a highly-diverse microbial community that plays an essential role in human health. There is a growing body of evidence that shows when there is a disruption of the composition and/or diversity of the gut microbiome, there may be an associated risk for serious illnesses, such as C. difficile infection.
C. difficile is a bacterium that causes debilitating symptoms such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea and colitis (an inflammation of the colon).1 Estimated to cause up to half a million illnesses and thousands of deaths annually in the U.S. alone every year, C. difficile infection is considered an urgent threat to public health by the CDC and can lead to severe complications, including hospitalization, surgery, sepsis and death.1,2 C. difficile infection is often the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.12,13 Theuse of antibiotics has been shown to disrupt the ecology of the gut microbiome, and are a predominant risk factor for C. difficile recurrence – occurring in up to 35% of patients after initial C. difficile infection diagnosis.4,5,10 After the first recurrence, it has been estimated that up to 60% of patients may develop a subsequent recurrence.14
Restoring the gut microbiome is increasingly accepted as a promising treatment option for recurrent C. difficile infection.15
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.
Ferring is committed to exploring the crucial link between the microbiome and human health, beginning with the threat of recurrent C. difficile infection. With the 2018 acquisition of Rebiotix and several other alliances, Ferring is a world leader in microbiome research, developing novel microbiome-based therapeutics to address significant unmet needs and help people live better lives. Connect with us on our dedicated microbiome therapeutics development channels on Twitter and LinkedIn.
Rebiotix Inc, a Ferring Company, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The platform consists of investigational drug technologies designed to potentially rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com, or connect with us on Twitter, Facebook, LinkedIn and YouTube.
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is a fully virtual meeting from May 21-23, 2021. The meeting showcases more than 2,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
- Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
- Centers for Disease Control and Prevention. Biggest Threats and Data. 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html.
- Fitzpatrick F, Barbut F. Breaking the cycle of recurrent Clostridium difficile infections. Clin Microbiol Infect. 2012;18(suppl 6):2-4.
- Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9):825-834.
- Cornely OA, et al. Treatment of First Recurrence of Clostridium difficile Infection: Fidaxomicin Versus Vancomycin. Clinical Infectious Diseases. 2012;55(S2):S154–61.
- Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
- Nelson WW, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims. J Manag Care Spec Pharm. Published online March 11, 2021.
- Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.
- Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
- Langdon A, Crook N, Dantas G. The effects of antibiotics on the microbiome throughout development and alternative approaches for therapeutic modulation. Genome Med. 2016;8(1):39.
- Centers for Disease Control and Prevention. Sepsis. 27 Jan. 2021. Available at: https://www.cdc.gov/sepsis/what-is-sepsis.html.
- Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
- Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
- Leong C, Zelenitsky S. Treatment strategies for recurrent Clostridium difficile infection. Can J Hosp Pharm. 2013;66(6):361-368.
- van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013;368(5):407-415.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
For more information, please contact
Director, Brand Communications
Communications & Digital Innovation
Associate Director, Marketing and Communications
Rebiotix Inc, a Ferring Company
Senior Manager, Corporate Communications
+41 58 451 4023 (direct)
+41 79 191 0486 (mobile)
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
MSCI 2021 Market Classification Review25.6.2021 00:09:00 CEST | Press release
MSCI Inc. (NYSE: MSCI), a leading provider of critical decision support tools and services for the global investment community, announced today the results of the MSCI 2021 Market Classification Review. “It is positive to see that most of the markets which imposed temporary accessibility restrictions to mitigate the impact of the COVID-19 pandemic have returned to normal operations,” said Dr. Dimitris Melas, Global Head of Index Research and Product Development and Chairman of the MSCI Index Policy Committee. “For the markets that continue to maintain some measure of restrictions due to COVID-19, with no explicit guidelines on when such restrictions will be lifted, their Market Accessibility assessment may be affected negatively.” MSCI Argentina Index reclassification to Standalone Markets status MSCI announced today that it will reclassify the MSCI Argentina Index from Emerging Markets to Standalone Markets status in one step coinciding with the November 2021 Semi‐Annual Index Review.
Abbas Hussain Appointed as New Chief Executive Officer of Vifor Pharma24.6.2021 20:00:00 CEST | Press release
Regulatory News: Abbas Hussain (56, British citizen) has a successful and international career of more than 30 years as an executive in the healthcare sector. From 2008 to 2017, Abbas Hussain held various leadership positions for the British pharmaceutical group GlaxoSmithKline, most recently as Global President Pharmaceuticals and Vaccines for five years. Prior to that, he worked for 20 years for the U.S. pharmaceutical group Eli Lilly, holding management positions at sites in the US, Europe, Asia and Australia. In recent years, he has contributed his experience as an independent member of the boards of directors of major pharmaceutical, biotech and medical device companies, such as Teva Pharmaceuticals, CSL and Cochlear. He has also acted as an advisor to private equity and venture capital firms focused on the healthcare sector. Abbas Hussain holds a Bachelor of Science in Medicinal and Pharmaceutical Chemistry from Loughborough Institute of Technology (UK), graduated from Duke Unive
Invivoscribe Launches Grant Program to Support Novel Applications for Sequence-Based Analyses of the Immune System24.6.2021 19:17:00 CEST | Press release
Invivoscribe, a global leader in precision diagnostics, has announced the launch of an Immune Biomarker Discovery grant program, focused on supporting development, validation and deployment of novel applications for use of their distributed LymphoTrack® NGS products and bioinformatics software. Massively parallel sequencing coupled with reagents targeting the immune receptor loci have accelerated our understanding of the immune response and immunology related disease processes. The availability of distributed RUO LymphoTrack tests and bioinformatics have eliminated a majority of the barriers of a service model approach, and have accelerated the ability to identify, track and monitor biomarkers associated with hematologic malignancies. These products are also being deployed worldwide to track the manufacture and treatment of immunotherapy, such as CAR T-cell therapies, and provide a comprehensive way to track a subject’s immune response to disease processes and to vaccines. In conversat
Nucleai and Merck KGaA Darmstadt, Germany Launch Translational Medicine Collaboration Utilizing Nucleai’s AI-Powered Biomarker Platform24.6.2021 17:17:00 CEST | Press release
Nucleai (www.nucleaimd.com), a precision medicine company using AI-powered image analysis technology to support novel pathology-based biomarker development, and Merck KGaA, Darmstadt, Germany, a leading science and technology company, announced that they have entered into a long-term collaboration to leverage Nucleai's image analysis and biomarker discovery platform for several Merck KGaA, Darmstadt, Germany clinical stage oncology assets. As part of the collaboration, Merck KGaA, Darmstadt, Germany will leverage Nucleai’s platform for exploratory research, with the potential to further develop identified pathology-based biomarkers as companion diagnostics. The collaboration will further utilize Nucleai’s technology to expand onto Merck KGaA, Darmstadt, Germany’s analysis capabilities, enabling faster turnaround time and scale for future studies. Nucleai's platform analyzes tissue images using computer vision and machine learning methods to model the tumor and the immune system's spati
Andersen Global Enters Collaboration Agreement With One of Lesotho’s Largest Law Firms24.6.2021 15:30:00 CEST | Press release
Andersen Global extends its African presence through a Collaboration Agreement with one of Lesotho’s largest law firms, Webber Newdigate Attorneys, enhancing the organization’s coverage in the southern region of the continent. Webber Newdigate Attorneys, established in 1978, is located in the capital city, Maseru. Recognized by Chambers Global and consistently awarded by PMR Africa, the full-service firm provides legal services to both local and international clients including individuals, companies, multinationals, government authorities, banks and parastatal organizations. The firm also covers a range of industries with capabilities in tax, real estate, employment law, corporate and commercial, litigation, banking and finance, mining and resources, immigration and family law. “For more than 40 years, our team has consistently delivered high-quality solutions to our clients, including those of an intricate nature,” said Partner Alex de Wet. “Andersen Global’s culture echoes our firm’s
New Outseer Fraud & Payments Report Confirms Massive Increase in Brand Abuse Cyber Attacks, Jumping 158% From Q1 202024.6.2021 15:00:00 CEST | Press release
Outseer has published its latest quarterly fraud and payments report, uncovering a significant spike in brand abuse attacks and a continued shift to more precise payment authentication methods. The Q2 installment of the report features insights from January through March of 2021 as captured through the Outseer Global Data Network, and collected while authenticating consumer transactions and investigating threats on behalf of Outseer customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210624005352/en/ (Graphic: Business Wire) According to the report, Brand Abuse attacks impersonating companies through social media and published content now represents the majority of fraud attacks, growing from 27% in Q4 2020 to 68% in Q1 2021. This dramatic shift is attributed to the increased use of digital platforms including social media, web publishing, and cloud-based collaboration tools during the pandemic – all fertile hunting gr
IATA Strengthens Operational Scalability By Switching to Rimini Street for Integrated Support and Application Management Services for its SAP Applications24.6.2021 15:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that International Air Transport Association (IATA), the leading commercial aviation trade association headquartered in Montreal, Canada, has switched to Rimini Street Support and Application Management Services (AMS) for its SAP ECC 6.0 and Business Objects applications. With the commercial aviation sector heavily affected by the COVID-19 pandemic, IATA made strategic business decisions to navigate the crisis, including outsourcing key elements of its IT service delivery to reduce operating costs. As a result of switching to Rimini Street, the organization now benefits from a unified support solution that integrates application support and managed services, enabling IATA to meet business demand in a post-pandemic recovery. This press release features multimedia. View t