Fecal microbiota, live-jslm(University of Alberta)

PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals today shared an oral presentation detailing microbiome restoration from the Phase 3b CDI-SCOPE study among patients with recurrent C. difficile (C. diff) infection (CDI) who received REBYOTA® (fecal microbiota, live – jslm). This research was presented at the American College of Gastroenterology’s annual meeting (ACG 2025), alongside new long-term safety data from CDI-SCOPE and a retrospective analysis exploring the impact of antibiotic washout periods on REBYOTA effectiveness. 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 CDI in individuals 18 years of age and older, following antibiotic treatment for C. diff infection. "The collective data presented at ACG continue to build compelling evidence for REBYOTA in managing recurrent CDI," said Raza Ahmed, MD, Senior Director of Medical Affairs, Ferring Pharmaceuticals. "The results of these analyses are consistent with our pivotal research, further strengthening the body of evidence for REBYOTA." The CDI-SCOPE trial is a multicenter, single-arm, phase 3b study evaluating the safety and efficacy of REBYOTA when administered by colonoscopy to adults with recurrent CDI (rCDI). Overall, 41 participants received REBYOTA, 39 of whom completed an 8-week visit, with a treatment success rate of 95%. For the ACG presentation, investigators analyzed the microbiome composition, diversity of bacterial populations, and the Microbiome Health Index™ for post-antibiotic dysbiosis (MHI-A) in participants with stool samples provided between baseline and 6 months (n=20) and those with a baseline sample and at least 1 post-administration sample (n=18). Compared with baseline, microbiome composition and MHI-A shifted significantly toward the REBYOTA composition among responders. Specifically, beneficial bacteria (Bacteroidia and Clostridia) increased in abundance, while disease-causing bacteria (Gammaproteobacteria and Bacilli) decreased following REBYOTA administration. Importantly, MHI-A values increased from baseline to 6 months after treatment, indicating a sustained shift toward a healthier microbiome state. “The restorative changes we observed in our analysis suggest a potential shift from a post-antibiotic state of dysbiosis to a healthier state with the colonization of bacteria more resistant to CDI,” said Dr. Sahil Khanna, Mayo Clinic and lead author on the study. “Importantly, administration by colonoscopy also demonstrated a safety profile consistent with pivotal studies.” A second abstract from the CDI-SCOPE study reported that the safety profile of REBYOTA through 6 months was consistent with results from previous trials. From week 8 through 6 months after treatment, researchers identified 36 additional treatment-emergent adverse events (TEAEs) in 15 participants (36.6%), with 1 (irritable bowel syndrome) considered treatment-related. Most TEAEs (97.2%) during this period were mild or moderate in severity, and 1 serious, potentially life-threatening TEAE (worsening abdominal pain) unrelated to REBYOTA was observed. No new safety signals were observed, and the safety profile was consistent with prior clinical trials. Across the full trial period, 6 REBYOTA-related TEAEs occurred in 4 participants (9.8%), all of which were mild in severity and gastrointestinal in nature. Serious TEAEs occurred in 3 participants (7.3%), none of which were related to REBYOTA or its administration. A third retrospective, multicenter analysis explored the impact of administering REBYOTA beyond the currently indicated 24- to 72-hour antibiotic washout period. Among 130 patients with rCDI, Group 1 (n=99) received REBYOTA within 24-72 hours (≤3 days) following standard-of-care antibiotic therapy while Group 2 (n=31) received treatment after 72 hours (>3 days, up to 42 days). Although the median washout period differed significantly between groups (2 days in Group 1 vs. 9 days in Group 2, p<0.0001), REBYOTA prevented recurrences despite being administered beyond the standard washout period. Recurrence was observed in 25.3% in Group 1 vs. 3.2% in Group 2, where the difference was statistically significant (p=0.008). Further analysis with a larger cohort is needed to confirm these early results. 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 ACG 2025 Founded in 1932, the American College of Gastroenterology (ACG) is an organization with an international membership of over 18,000 individuals from 86 countries. The College’s vision is to be the preeminent professional organization that champions the prevention, diagnosis, and treatment of digestive disorders, serving as a beacon to guide the delivery of the highest quality, compassionate, and evidence-based patient care. The mission of the College is to enhance the ability of our members to provide world class care to patients with digestive disorders and advance the profession through excellence and innovation based upon the pillars of Patient Care, Education, Scientific Investigation, Advocacy and Practice Management. www.gi.org References: Centers for Disease Control and Prevention. About C. diff. Dec. 2024. Available at: https://www.cdc.gov/c-diff/about/index.html 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 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. 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 Jul;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.

PARSIPPANY, N.J.--(BUSINESS WIRE)--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: Centers for Disease Control and Prevention. About C. diff. Dec. 2024. Available at: https://www.cdc.gov/c-diff/about/index.html 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 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. 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 Jul;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.