Ferring to Present Analyses for Investigational Microbiota-Based Live Biotherapeutic RBX2660 in Patients with Recurrent C. Difficile Infection at ACG 2022
Parsippany, NJ – October 11, 2022 – Ferring Pharmaceuticals today announced it will present data from new analyses of RBX2660, an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of C. difficile infection (CDI) after antibiotic treatment. The data will be presented as part of the American College of Gastroenterology’s Annual Scientific Meeting & Postgraduate Course (ACG) 2022. The congress will take place in Charlotte, North Carolina from October 21 to 26.
The analyses presented at ACG will review the efficacy and safety of RBX2660 across different subgroups and comorbidities, as well as 24-month data from a Phase 2 study. In addition, data will be presented that measures the physical, mental, and social health-related quality of life in patients with recurrent CDI. Notably, the oral presentation has received an award for Outstanding Research in the Colon Category.
Descriptions of the abstracts accepted for presentation are as follows:
Presentation 56 Description (Oral) – An Ad Hoc Analysis of an Open-Label Study Indicating Efficacy and Safety of RBX2660
Presenting Author: Sahil Khanna, MBBS, MS, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN
EMBARGOED UNTIL: 12:00 pm EDT on Sunday, October 23, 2022
Poster D0100 Description – Efficacy and Safety of RBX2660 in Patients with Clostridioides difficile Infection – Interim Results From an Open-Label Phase 3 Study
Presenting Author: Sahil Khanna, MBBS, MS, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN
EMBARGOED UNTIL: 12:00 pm EDT on Sunday, October 23, 2022
Poster E0349 Description – An Analysis from the RBX2660 Phase 3 Trial (PUNCH CD3) on Health-Related Quality of Life in Patients With Recurrent Clostridioides difficile Infection
Presenting Author: Amy Guo, Ph.D., Ferring Pharmaceuticals, Parsippany, NJ
EMBARGOED UNTIL: 12:00 pm EDT on Sunday, October 23, 2022
Poster E0100 Description – A Subgroup Analysis for 24-Month Sustained Clinical Response and Safety of RBX2660
Presenting Author: Robert Orenstein, DO, Chairman, Division of Infectious Diseases, Mayo Clinic, Phoeniz, AZ
EMBARGOED UNTIL: 12:00 pm EDT on Sunday, October 23, 2022
Poster D0099 Description – An Ad Hoc Subgroup Analysis of Efficacy and Safety of RBX2660 in Patients With Underlying Gastrointestinal Comorbidities
Presenting Author: Sahil Khanna, MBBS, MS, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN
EMBARGOED UNTIL: 12:00 pm EDT on Sunday, October 23, 2022
Poster D0098 Description – A Subgroup, Post-Hoc Analysis of Efficacy and Safety of RBX2660 in Patients Grouped by Age and Underlying Comorbidities
Presenting Author: Paul Feuerstadt, MD, FACG, AGAF, PACT Gastroenterology, Hamden, CT, Assistant Clinical Professor of Medicine, Yale University School of Medicine, New Haven, CT
EMBARGOED UNTIL: 12:00 pm EDT on Sunday, October 23, 2022
Poster E0348 Description – Health-Related Quality of Life of Week 8 Responders and Non-Responders to RBX2660
Presenting Author: Amy Guo, Ph.D., Ferring Pharmaceuticals, Parsippany, NJ
EMBARGOED UNTIL: 12:00 pm EDT on Sunday, October 23, 2022
ACG 2022 has made abstracts available on their website.
About C. difficile infection
C. difficile infection (CDI) is a serious and potentially deadly disease that impacts people across the globe. The C. difficile 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 Declared a public health threat by the U.S. Centers for Disease Control and Prevention (CDC) requiring urgent and immediate action, CDI causes an estimated half a million illnesses and tens of thousands of deaths in the U.S. alone each year.1,2,3
C. difficile infection often is the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.4,5It has been estimated that up to 35% of CDI cases recur after initial diagnosis1,2and people who have had a recurrence are at significantly higher risk of further infections.6,7,8,9 After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence.8,9
About RBX2660
RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of C. difficile infection after antibiotic treatment. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). RBX2660 was developed by Rebiotix, a Ferring company.
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, and in specialty areas within gastroenterology and orthopaedics. For more information, call 1-888-FERRING + (1-888-337-7464); visit http://www.ferringusa.com/.
Ferring is committed to exploring the crucial link between the microbiome and human health, beginning with the threat of recurrent C. difficile infection. Ferring is working to develop 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.
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For more information, please contact:
Lisa Ellen
Director, Brand Communications
E: lisa.ellen@ferring.com
P: +1-862-286-5696
References:
- 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. Clin Microbiol Infect. 2012;18(suppl 6):2-4.
- 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.
- 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.