Ferring Pharmaceuticals: Ferring and Rebiotix to Present Landmark Data for Investigational Microbiota-based Live Biotherapeutic RBX2660 at Digestive Disease Week (DDW) 2021

• For the first time ever, Ferring and Rebiotix, a Ferring Company, will present landmark Phase 3 efficacy and safety data from the PUNCH CD3 trial evaluating investigational microbiota-based live biotherapeutic RBX2660 for reduction of recurrent Clostridioides difficile(C. difficile) infection. This trial is part of the world's largest and most robust clinical development program in microbiome-based therapeutics.

• Additionally, an interim analysis of the PUNCH CD3-Open-Label Study (OLS) will be presented for the first time. PUNCH CD3-OLS has expanded inclusion criteria allowing for enrollment of patients with recurrent C. difficile infection who healthcare providers more commonly see in clinical practice, including those with co-morbidities such as inflammatory bowel disease (IBD).

• The final presented study will be an innovative analysis evaluating mortality rates and healthcare costs among U.S. Medicare patients with primary and recurrent C. difficile infection who may also have experienced sepsis, a potentially devastating complication of C. difficile infection.

Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today announced that Phase 3 data evaluating its investigational microbiota-based live biotherapeutic RBX2660 for reduction of recurrent Clostridioides difficile(C. difficile) infection will be presented as part of an invited talk at Digestive Disease Week (DDW) 2021. The congress will take place virtually from May 21-23, 2021.

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"These data are the pinnacle of a decade of ground-breaking research and development, driven by the goal of helping those who are experiencing the debilitating effects of recurrent C. difficile infection," said Lee Jones, Founder, President and Chief Executive Officer of Rebiotix, a Ferring Company. "We're striving to deliver innovative therapeutics to help people live better lives, and are proud to be pioneering a new category of scientifically-validated, microbiome-based therapeutics that are standardized for quality and safety. We're looking forward to sharing this milestone data with the entire community at DDW."

The clinical development program for RBX2660 is the largest and most robust ever conducted in the field of microbiome-based therapeutics, including six clinical trials enrolling more than 1,000 patients to date.

C. difficile infection is a serious and potentially deadly disease that impacts people across the globe. Declared a public health threat by the U.S. Centers for Disease Control and Prevention (CDC) requiring urgent and immediate action, C. difficile infection 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 recurs in up to 35% of cases after initial diagnosis^4,5 and people who have had a recurrence are at significantly higher risk of further infections.^6,7,8,9 Recurrent C. difficile infection (rCDI) is associated with disruptions to the gut microbiome, or "dysbiosis". The current standard of care treatment for rCDI is antibiotics, which does not address the underlying dysbiosis or restore the gut microbiome.¹⁰

To further amplify the impact of this devastating disease, Ferring will also present an analysis of mortality rates and healthcare costs among Medicare patients with primary C. difficile infection and rCDI in cohorts of patients with and without sepsis. Sepsis, the body's extreme response to an infection and a life-threatening medical emergency¹¹, can be a complication of C. difficile infection.

The details of the three presentations are as follows:

Session Number: 2155
Session Title: Beyond FMT: A Pragmatic Approach to Microbiome Therapies: RBX2660 Study
Presenting Author: Christine Lee, MD, FRCPC, Clinical Professor, Department of Pathology and Laboratory Medicine, UBC Faculty of Medicine; Medical Microbiologist and Researcher, Island Health
EMBARGOED UNTIL PRESENTATION TIME: FRIDAY, MAY 21 AT 1:24 PM ET

Session Number: 6320
Poster Number: Sa611
Title: Interim Analysis of a Phase 3 Open-Label Study Indicates Safety and Efficacy of RBX2660, an Investigational Live Biotherapeutic, in a "Real-World" Population of Patients With Recurrent Clostridioides difficile Infection
Presenting Author: Colleen Kraft, MD, Associate Professor, Division of Infectious Diseases, Emory University School of Medicine
EMBARGOED UNTIL PRESENTATION TIME: SATURDAY, MAY 22 AT 12:15 PM ET

Session Number: 5345
Poster Number: Fr559
Title: A Real-World Comparison of Mortality, Healthcare Resource Utilization, and Cost Among Medicare Beneficiaries with Clostridioides difficile Infection With and Without Sepsis
Presenting Author: Alpesh Amin, MD, MBA, Thomas Mary Cesario Chairman, Department of Medicine, Executive Director, Hospitalist Program, University of California Irvine
EMBARGOED UNTIL PRESENTATION TIME: FRIDAY, MAY 21 AT 12:15 PM ET

DDW has made abstracts available on their website.

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 the gut microbiome and C. difficile infection

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, such as C. difficile infection.

C. difficile is a bacterium that causes debilitating symptoms such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea and colitis (an inflammation of the colon).¹ Estimated to cause up to half a million illnesses and thousands of deaths annually in the U.S. alone every year, C. difficile infection is considered an urgent threat to public health by the CDC and can lead to severe complications, including hospitalization, surgery, sepsis and death.^1,2 C. difficile infection is often the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.^12,13 Theuse of antibiotics has been shown to disrupt the ecology of the gut microbiome, and are a predominant risk factor for C. difficile recurrence occurring in up to 35% of patients after initial C. difficile infection diagnosis.^4,5,10 After the first recurrence, it has been estimated that up to 60% of patients may develop a subsequent recurrence.¹⁴

Restoring the gut microbiome is increasingly accepted as a promising treatment option for recurrent C. difficile infection.¹⁵

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. 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 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 DDW

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is a fully virtual meeting from May 21-23, 2021. The meeting showcases more than 2,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

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 infections. Clin Microbiol Infect. 2012;18(suppl 6):2-4.
4. 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.
5. Cornely OA, et al. Treatment of First Recurrence of Clostridium difficile Infection: Fidaxomicin Versus Vancomycin. Clinical Infectious Diseases. 2012;55(S2):S154-61.
6. Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
7. 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.
8. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21-27.
9. Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
10. 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.
11. Centers for Disease Control and Prevention. Sepsis. 27 Jan. 2021. Available at: https://www.cdc.gov/sepsis/what-is-sepsis.html.
12. Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
13. Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
14. Leong C, Zelenitsky S. Treatment strategies for recurrent Clostridium difficile infection. Can J Hosp Pharm. 2013;66(6):361-368.
15. 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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Contacts:

For more information, please contact

Heather Guzzi
Director, Brand Communications
Communications Digital Innovation
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Courtney Jones
Associate Director, Marketing and Communications
Rebiotix Inc, a Ferring Company
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Lindsey Rodger
Senior Manager, Corporate Communications
[phone] (direct)
[phone] (mobile)
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