NJ-FERRING/REBIOTIX

Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today announced they will present data from two new retrospective analyses as part of American College of Gastroenterology’s Annual Scientific Meeting & Postgraduate Course (ACG 2021 ). The congress will take place in Las Vegas from October 22 – 27, 2021.

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Eligibility criteria in CDI clinical trials often are narrowly defined, excluding broader patient populations. The first presentation will explore key health outcomes of RBX2660, an investigational microbiota-based live biotherapeutic for reduction of recurrent C. difficile infection (CDI), among patients in a real-world setting. The second analysis evaluates healthcare resource utilization and medical costs among Medicare patients with CDI with or without inflammatory bowel disease (IBD) as a comorbidity. Notably, one of the presentations has received The Presidential Poster Award acknowledging high quality, novel, unique and interesting research.

Descriptions of the two abstracts accepted for presentation are as follows:

Poster P2217 Description – A retrospective analysis of use of investigational RBX2660 given under enforcement discretion in a real-world CDI population. Presidential Poster Award recipient.

Presenting Author: Paul Feuerstadt, MD, FACG, AGAF, PACT Gastroenterology, Hamden, Conn., Assistant Clinical Professor of Medicine, Yale University School of Medicine, New Haven, Conn.

EMBARGOED UNTIL: October 24, 2021 at 3:30 PM EDT

Poster P2611 Description – A retrospective real-world analysis examining costs among Medicare beneficiaries with CDI, with or without IBD

Presenting Author: Paul Feuerstadt, MD, FACG, AGAF, PACT Gastroenterology, Hamden, Conn., Assistant Clinical Professor of Medicine, Yale University School of Medicine, New Haven, Conn.

EMBARGOED UNTIL: October 24, 2021 at 3:30 PM EDT

ACG 2021 has made abstracts available on their website .

About the gut microbiome and 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.^4,5 Up to 35% of CDI cases recur after initial diagnosis^6,7 and people who have had a recurrence are at significantly higher risk of further infections.^8,9,10,11 After the first recurrence, it has been estimated that up to 60% of patients may develop a subsequent recurrence.¹²

Recurrent C. difficile infection (rCDI) is associated with disruptions to the gut microbiome, or “dysbiosis”. The gut microbiome is a highly-diverse microbial community that plays an essential role in human health. There is a growing body of evidence that shows when there is a disruption of the composition and/or diversity of the gut microbiome, there may be an associated risk for serious illnesses, including CDI. The current standard of care treatment for rCDI is antibiotics, which does not address the underlying dysbiosis or restore the gut microbiome.¹³ The use of antibiotics has been shown to disrupt the ecology of the gut microbiome and are a predominant risk factor for rCDI.^6,7,13

Restoring the gut microbiome is increasingly accepted as a promising treatment option for recurrent C. difficile infection.¹⁴

About RBX2660

RBX2660 is a potential first-in-class microbiota-based live biotherapeutic being studied to deliver a broad consortium of diverse microbes to the gut to reduce recurrent C. difficile infection. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). The pivotal Phase 3 program builds on nearly a decade of research with robust clinical and microbiome data collected over six controlled clinical trials with more than 1,000 participants.

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. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. Learn more at www.ferring.com , or connect with us on Twitter , Facebook , Instagram , LinkedIn and YouTube .

Ferring is committed to exploring the crucial link between the microbiome and human health, beginning with the threat of recurrent C. difficile infection. With the 2018 acquisition of Rebiotix and several other alliances, Ferring is a world leader in microbiome research, developing novel microbiome-based therapeutics to address significant unmet needs and help people live better lives. The Ferring Research Institute Inc. (FRI), based in San Diego, USA, is part of the Global Drug Discovery & External Innovation unit, which is the research and ideas engine of Ferring Pharmaceuticals. FRI is an integral part of Ferring’s R&D organization, focusing on early drug discovery and development. Connect with us on our dedicated microbiome therapeutics development channels on Twitter and LinkedIn .

About Rebiotix

Rebiotix Inc, a Ferring Company, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT^TM drug platform . The platform consists of investigational drug technologies designed to potentially rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com , or connect with us on Twitter , Facebook , LinkedIn and YouTube .

About ACG

The 2021 ACG Annual Scientific Meeting & Postgraduate Course will convene in Las Vegas, NV from October 22 to 27, 2021. The American College of Gastroenterology (ACG) is a recognized leader in educating GI professionals and the general public about digestive disorders. Our mission is to advance world-class care for patients with gastrointestinal disorders through excellence, innovation, and advocacy in the areas of scientific investigation, education, prevention, and treatment. To learn more about ACG, visit our website .

References:

1. Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html .
2. Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html .
3. Fitzpatrick F, Barbut F. Breaking the cycle of recurrent Clostridium difficile. Clin Microbiol Infect. 2012;18(suppl 6):2-4.
4. Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
5. Feuerstadt P, et al. J Med Econ . 2020;23(6):603-609.
6. Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9):825-834.
7. Cornely OA, et al. Treatment of First Recurrence of Clostridium difficile Infection: Fidaxomicin Versus Vancomycin. Clinical Infectious Diseases . 2012;55(S2):S154–61.
8. Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am . 2009;23(3):727-743.
9. Nelson WW, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims. J Manag Care Spec Pharm . Published online March 11, 2021.
10. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.
11. Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers . 2016;2:16020. doi: 10.1038/nrdp.2016.20.
12. Leong C, Zelenitsky S. Treatment strategies for recurrent Clostridium difficile infection. Can J Hosp Pharm . 2013;66(6):361-368.
13. Langdon A, Crook N, Dantas G. The effects of antibiotics on the microbiome throughout development and alternative approaches for therapeutic modulation. Genome Med . 2016;8(1):39.
14. van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile . N Engl J Med. 2013;368(5):407-415.

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