• Results from two real-world studies, presented at IDWeek 2025, include initial registry findings and highlight consistent efficacy and safety of REBYOTA for preventing recurrent C. diff infection
• Improvements in patients' health-related quality of life were observed in one analysis
• These findings further build on the collective real-world evidence supporting use of REBYOTA in routine clinical practice

Ferring Pharmaceuticals announced the presentation of two real-world data analyses for REBYOTA^® (fecal microbiota, live-jslm) at IDWeek 2025. These analyses highlight the effectiveness and safety of REBYOTA in preventing recurrent Clostridioides difficile infection (rCDI) in real-world clinical practice, including its positive impact on patients' health-related quality of life (HR-QOL).

REBYOTA is the first and only single-dose fecal microbiota transplant (FMT) approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent C. difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for C. diff infection.

“Recurrent C. diff infection remains a critical public health issue marked by a vicious cycle of recurrent infections that can significantly diminish a patient’s quality of life for both themselves and the family around them,” said Nicholas W. Van Hise, PharmD, Metro Infectious Disease Consultants. “The findings from these real-world studies are highly encouraging as they support the vital role of a single-dose FDA-approved LBP in the prevention of rCDI. This HR-QOL data underscores the profound impact that halting the cycle of recurrence can have on patients’ daily lives, extending beyond just clinical outcomes.”

In the first analysis (presentation number 352), 75% of patients (n=96/128) aged ≥18 years with rCDI who received REBYOTA in physician offices between February 2023 and March 2025 achieved treatment success (defined as no CDI recurrence) at 8 weeks. Recurrent infection was experienced by 21% (n=27). Importantly, among the 40 patients who completed both baseline and 8-week HR-QOL surveys – using the validated Cdiff32 instrument – the mean and standard deviation (mean ± SD) HR-QOL scores significantly improved from 41.4 ± 17.3 at baseline to 57.5 ± 17.8 at week 8. This 16-point gain exceeds the minimal clinically important difference for the Cdiff32 instrument, indicating clinically meaningful benefit. Improvements were observed across all domains (physical, mental, and social functioning).

The second abstract (poster number 1017) reported interim results from an ongoing, prospective non-interventional registry of patients receiving REBYOTA for rCDI. The analysis included 76 patients who received REBYOTA within 30 days of completing antibiotics for rCDI and completed 8 weeks of follow-up. The patient cohort was predominantly white (93.4%) and female (76.3%), with a median age of 69 years. Through 8 weeks, 82.9% of patients (63/76; 95% CI, 72.5%-90.6%) experienced treatment success (no CDI recurrence). These interim registry data are limited to short-term follow-up and may be subject to selection bias. Importantly, treatment success was 87.8% (36/41) in the subgroup that received REBYOTA after an antibiotic washout period >72 hours, with subgroup outcomes ranging from 77% to 100%.

There were no new safety signals, and the adverse events profile was consistent with prior clinical trials.

In the study, 18 (23.7%) patients experienced an adverse event (AE), 6 (7.9%) experienced a serious AE, and 1 (1.3%) experienced an AE of special interest (large bowel obstruction). AEs assessed as related to REBYOTA occurred in 3 patients (3.9%), and there was 1 fatal AE during the study, considered unrelated to REBYOTA.

“These real-world results reinforce REBYOTA’s consistent effectiveness and safety profile, and importantly, highlight its positive impact on patients’ health-related quality of life,” said Raza Ahmed, MD, Senior Director of Medical Affairs, Ferring Pharmaceuticals. “Ferring is committed to generating real-world evidence that supports healthcare providers in making informed decisions for patients battling recurrent C. difficile infection.”

To learn more about REBYOTA and other information, please visit REBYOTA.com or REBYOTAHCP.com.

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 privately-owned, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. The company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees.

For more information, please visit www.ferringusa.com, call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X.

About IDWeek

IDWeek is the joint annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society and the Society of Infectious Diseases Pharmacists. 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. About C. diff. Dec. 2024. Available at: https://www.cdc.gov/c-diff/about/index.html
2. Centers for Disease Control and Prevention. 2019 Antibiotic Resistance Threats Report: Clostridioides difficile. 23 Nov. 2021. Available at: https://www.cdc.gov/antimicrobial-resistance/media/pdfs/clostridioides-difficile-508.pdf?CDC_AAref_Val=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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