Ferring to Present New Data Analyses at IDWeek 2023 for REBYOTA® (fecal microbiota, live – jslm), the First and Only Single-Dose, FDA Approved Microbiome-Based Treatment for the Prevention of Recurrent C. difficile Infection

Ferring Pharmaceuticals today announced it will present analyses of data for REBYOTA^® (fecal microbiota, live – jslm), the first and only single-dose, FDA approved microbiome-based treatment to prevent recurrent Clostridioides difficile (C. diff) infection after antibiotic treatment, as part of Infectious Disease Week (IDWeek) 2023. The congress will take place in Boston, Mass., from October 11 to 15.

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Data presented at IDWeek will evaluate initial real-world use of REBYOTA in gastroenterology and infectious disease clinical practices, efficacy and safety of REBYOTA in patients with renal comorbidities, and efficacy of REBYOTA in patients who received antibiotics for another illness after treatment with REBYOTA. An additional analysis will focus on associations between a healthier gut microbiome and health-related quality of life.

Descriptions of the abstracts accepted for presentation are as follows:

Poster 685 Title – Early Experience With a Simple Administration of a Novel Fecal Microbiome Replacement for Prevention of Recurrent Clostridioides difficile

Presenting Author: Richard L. Hengel, M.D., Partner, Atlanta ID Group, Atlanta, Ga.

EMBARGOED UNTIL: Wednesday, October 11, 2023, at 12:01 a.m. ET

Poster 706 Title – An Ad Hoc Subgroup Analysis of a Phase 3, Open-Label Study Indicates Efficacy and Safety of Fecal Microbiota, Live – jslm in Participants With Recurrent Clostridioides difficile Infection and Renal Impairment

Presenting Author: Glenn Tillotson, Ph.D., F.R.S.M., F.C.C.P., GST Micro, North, Va.

EMBARGOED UNTIL: Wednesday, October 11, 2023, at 12:01 a.m. ET

Poster 702 Title – Efficacy of Fecal Microbiota, Live – jslm After Receipt of Non-Clostridioides difficile Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Trial

Presenting Author: Andrew Skinner, M.D., University of Utah School of Medicine and George E. Wahlen VA Hospital, Salt Lake City, Utah

EMBARGOED UNTIL: Wednesday, October 11, 2023, at 12:01 a.m. ET

Poster 366 Title – Association Between Gut Microbiota and Health-Related Quality of Life in Patients with Recurrent Clostridioides difficile Infection: Results from the PUNCH CD3 Clinical Trial

Presenting Author: Paul Feuerstadt, M.D., F.A.C.G., A.G.A.F., PACT Gastroenterology, Hamden, Conn.; Assistant Clinical Professor of Medicine, Yale University School of Medicine, New Haven, Conn.

EMBARGOED UNTIL: Wednesday, October 11, 2023, at 12:01 a.m. ET

IDWeek 2023 has made 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 www.FDA.gov/medwatch 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 http://www.ferringusa.com/.

Connect with us on our dedicated microbiome therapeutics development channels on Twitter and LinkedIn.

About IDWeek

IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). IDWeek is a recognized forum for peer-reviewed presentations of new research on scientific advances and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. For more information, visit www.idweek.org.

References:

1. Centers for Disease Control and Prevention. What is C. diff? 7 Sep. 2022. Available at: https://www.cdc.gov/cdiff/what-is.html.
2. Centers for Disease Control and Prevention. 2019 Antibiotic Resistance Threats Report: Clostridioides difficile. 23 Nov. 2021. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
3. Feuerstadt P, et al. Healthcare resource utilization and direct medical costs associated with index and recurrent Clostridioides difficile infection: a real-world data analysis. J Med Econ. 2020;23(6):603-609.
4. Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
5. 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 Jul;27(7):828-838. doi: 10.18553/jmcp.2021.20395. Epub 2021 Mar 11.
6. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18(Suppl. 6):21-27.
7. Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.

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