Ferring to Present Analyses of Data for REBYOTA™ (fecal microbiota, live – jslm), the First FDA-Approved Microbiome-Based Treatment for the Prevention of Recurrent C. difficile Infection, at DDW 2023

2023-04-18

临床3期上市批准微生物疗法

PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals today announced it will present analyses of data for REBYOTA™ (fecal microbiota, live – jslm) at Digestive Disease Week® (DDW 2023). The congress will take place May 6-9, 2023, in Chicago, Ill. REBYOTA is the first microbiome-based treatment approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent C. difficile (C. diff) infection in adults, following antibiotic treatment for recurrent C. diff infection. REBYOTA is not indicated for the treatment of C. diff infection. This press release features multimedia. View the full release here: The analyses will review the safety of REBYOTA (previously known as RBX2660) in patients with inflammatory bowel disease, as well as safety and efficacy in immunocompromised patients and when administered by colonoscopy. An additional analysis looked at microbiome compositional changes and clonal engraftment following treatment with REBYOTA. Accepted presentations and poster are as follows: Oral Presentation: 699 – Description – Safety outcomes and concomitant medication changes in patients with inflammatory bowel disease being treated with RBX2660 for recurrent Clostridioides difficile infection. Presenting Author: Jessica Allegretti, M.D., M.P.H., Brigham & Women’s Hospital, Boston, Mass. EMBARGOED UNTIL: 12:01 a.m. CDT (1:01 a.m. EDT) May 8, 2023 Oral Presentation: 700 – Description – Safety and efficacy of RBX2660 in reducing recurrent Clostridioides difficile infection in immunocompromised patients. Presenting Author: Carolyn D. Alonso, M.D., Beth Israel Deaconess Medical Center, Boston, Mass.; Harvard Medical School, Boston, Mass. EMBARGOED UNTIL: 12:01 a.m. CDT (1:01 a.m. EDT) May 8, 2023 Poster: Su1866 – Description – Retrospective subgroup analysis of RBX2600 administered by colonoscopy under enforcement discretion for the reduction of recurrent Clostridioides difficile infection Presenting Author: Paul Feuerstadt, M.D., F.A.C.G., A.G.A.F., P.A.C.T. Gastroenterology, Hamden, Conn.; Assistant Clinical Professor of Medicine, Yale University School of Medicine, New Haven, Conn. EMBARGOED UNTIL: 12:15 p.m. CDT (1:15 p.m. EDT) May 7, 2023 Oral Presentation: 697 – Description – Significant and durable microbiome compositional changes and clonal engraftment in a Phase 3 trial of RBX2660 for recurrent Clostridioides difficile infection Presenting Author: Ken Blount, Ph.D., Rebiotix Inc., a Ferring Company, Roseville, Minn. EMBARGOED UNTIL: 12:01 a.m. CDT (1:01 a.m. EDT) May 8, 2023 DDW 2023 has abstracts available on its website. About C. diff infection C. diff infection is a serious and potentially deadly infection that impacts people across the globe. The C. diff bacterium causes debilitating symptoms, such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea and colitis (an inflammation of the colon).1 C. diff infection can be the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.2,3 It has been estimated that up to 35% of C. diff infection cases recur after initial diagnosis and people who have had a recurrence are at significantly higher risk of further infections.4,5,6,7 After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence.6,7 Antibiotics – the current standard of care for treatment of C. diff infection – treat the disease but can also be a contributing factor to the cycle of recurrence.1 About REBYOTA REBYOTA is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of up to trillions of live microbes – including Bacteroides. REBYOTA is delivered directly to the gut microbiome and is administered by a healthcare professional in one visit. INDICATION REBYOTA (fecal microbiota, live – jslm) is indicated for the prevention of recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection. Limitation of Use REBYOTA is not indicated for the treatment of C. diff infection. IMPORTANT SAFETY INFORMATION You should not receive REBYOTA if you have a history of a severe allergic reaction (e.g., anaphylaxis) to REBYOTA or any of its components. You should report to your doctor any infection you think you may have acquired after administration. REBYOTA may contain food allergens. Most common side effects may include stomach pain (8.9%), diarrhea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%). REBYOTA has not been studied in patients below 18 years of age. Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults. You are encouraged to report negative side effects of prescription drugs to FDA. Visit or call 1-800-332-1088. Please click to see the full Prescribing Information. 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. In the United States, Ferring is a leader in reproductive medicine and maternal health, uro-oncology and in specialty areas within gastroenterology, including microbiome therapeutics, and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464) or visit . Connect with us on our dedicated microbiome therapeutics development channels on Twitter and LinkedIn. About DDW 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 an in-person and online meeting from May 6-9, 2023. The meeting showcases more than 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at References: Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: . Centers for Disease Control and Prevention. 24 June 2020. Available at: . Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609. 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 analysis. J Manag Care Spec Pharm. 2021;27(7):828-838. doi: 10.18553/jmcp.2021.20395. Epub 2021 Mar 11. 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.