Ferring and Rebiotix Present Flagship Phase 3 Data Demonstrating Superior Efficacy of Investigational RBX2660 Compared to Placebo in Reducing Recurrence of C. difficile Infection


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SAINT-PREX, Switzerland & ROSEVILLE, Minnesota – (BUSINESS WIRE) – Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today presented the results of the pivotal phase 3 PUNCH â„¢ CD3 clinical trial, demonstrating superior efficacy and consistent safety of single-dose RBX2660 in reducing recurrence of Clostridioides difficile infection (CDI) compared to placebo. RBX2660 is a first-class experimental and potential living biotherapeutic based on the microbiota.

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The trial, presented today at Digestive Disease Week® (DDW) 2021, successfully achieved its primary endpoint. RBX2660 demonstrated superior efficacy compared to placebo (70.4% and 58.1%, respectively) 8 weeks after treatment, with a safety profile comparable to placebo. RBX2660 results demonstrated statistical significance with a posterior probability of superiority of 98.6%, exceeding the minimum threshold of 97.5%. In addition to these results, RBX2660 provided a relative reduction in recurrence of 29.4% compared to placebo. The majority of treatment-experienced adverse events (ATIA) for RBX2660 were similar to placebo and mild to moderate in nature. These data add to the large body of evidence showing consistent efficacy and safety in patients who have received RBX2660, which may help meet the unmet needs of patients with this debilitating and potentially fatal recurrent infection.

“VS. difficile is a global public health threat that requires immediate action to end the relentless cycle of relapse. Although they are necessary to treat the initial infection, antibiotics are also a predominant risk factor for recurrence as they can disrupt the gut microbiome, leaving the current treatment paradigm for incomplete recurrent infection, ”said Paul Feuerstadt, MD, FACG, AGAF, PACT Gastroenterology, Hamden, Conn., Assistant Clinical Professor of Medicine, Yale University School of Medicine, New Haven, Connecticut, and RBX2660 Clinical Trial Investigator. “These RBX2660 phase 3 results, as part of the overall clinical development program, show consistent efficacy from the first recurrence of C. difficile infection by providing a large consortium of microbes living in the area of ​​active infection. “

“People who have C. difficile infection are devastated when they come back. Patients told me they felt hopeless when the infection came back again and again despite multiple antibiotic treatments. They thought the infection would never go away ”. said Christine Lee, MD, FRCPC, Clinical Professor, Department of Pathology and Laboratory Medicine, UBC School of Medicine, Medical Microbiologist and Researcher, Island Health, Vancouver, and RBX2660 Clinical Trial Investigator who presented the data to DDW. “The results of this pivotal phase 3 trial of RBX2660 are very encouraging for both patients and healthcare professionals, giving hope that this potential new treatment could make a significant difference in the lives of patients with severe disease. recurrent C. difficile infection.

The RBX2660 program is the largest and most robust clinical program ever in microbiome-based therapy. The decade-long development program consists of six trials with over 1,000 patients enrolled; two of these trials are the only ones in the field to include two years of follow-up.

These Phase 3 results demonstrate a decade of robust clinical research to help address a significant unmet patient need ”. said Lee Jones, president and CEO of Rebiotix, a Ferring company. We are deeply grateful to the patients and clinicians for their years of dedication to this program.

“At Ferring, we are committed to helping people live better”, said Per Falk, president of Ferring Pharmaceuticals. “We are eager to share our data with the US FDA as we believe, based on the totality of the evidence, that RBX2660 has the potential to be an improvement over the standard of care alone for tens of thousands of patients. affected each year by C. difficile. “

About the PUNCH â„¢ CD3 clinical trial (Clinicaltrials.gov identifier: NCT03244644)

PUNCH â„¢ CD3 is a phase 3, prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of RBX2660 compared to placebo in the prevention of IRDr. The study included adults aged 18 or older who had at least one recurrence after a primary episode of CDI. Participants were followed for up to 8 weeks for efficacy analysis and up to 6 months for safety analysis.

About RBX2660

RBX2660 is a potential living microbiota-based biotherapeutic potential being investigated to deliver a large consortium of various microbes to the gut to reduce recurrence. It’s hard infection. RBX2660 has received the United States Food and Drug Administration (FDA) Accelerated, Orphan, and Revolutionary Therapy designations. The pivotal Phase 3 program builds on nearly a decade of research with strong clinical and microbiological data collected through six controlled clinical trials with more than 1,000 participants.

About the microbiome and It’s hard infection

The microbiome is a very diverse microbial community that plays an essential role in human health. A growing body of evidence shows that if there is a disruption in the composition and / or diversity of the gut microbiome, there may be an associated risk of serious diseases, such as It’s hard infection.

It’s hard is a bacteria 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 It is estimated to cause up to half a million illnesses and thousands of deaths a year in the United States alone each year, It’s hard the infection is considered an urgent public health threat by the CDC and can lead to serious complications, including hospitalization, surgery, sepsis, and death.1.2 It’s hard infection is often the start of a vicious cycle of recurrence, placing a significant burden on patients and the healthcare system.3.4 The use of antibiotics has been shown to disrupt the ecology of the gut microbiome and is a predominant risk factor for It’s hard recurrence – occurring in up to 35% of patients after It’s hard diagnosis of infection.5.6.7 After the first recurrence, it is estimated that up to 60% of patients may develop a subsequent recurrence.8

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. Based in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, as well as specialty areas in gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio spanning treatments from conception to birth. Founded in 1950, the privately held Ferring today employs around 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. Learn more about www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and Youtube.

Ferring pledges to explore crucial link between microbiome and human health, starting with threat of recurrence It’s hard infection. With the 2018 acquisition of Rebiotix and several other alliances, Ferring is a global leader in microbiome research, developing new microbiome-based therapies to address important unmet needs and help people live better lives. Connect with us on our therapeutic development channels dedicated to the microbiome at Twitter and LinkedIn.

About Rebiotix

Rebiotix Inc, a Ferring Company, is an advanced clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of difficult diseases. Rebiotix has a diverse portfolio of experimental pharmaceuticals based on its innovative microbiota MRT â„¢ drug platform. The platform consists of experimental drug technologies designed to potentially rehabilitate the human microbiome by delivering a large consortium of microbes living in a patient’s intestinal tract. For more information on Rebiotix and its portfolio of therapies directed against the human microbiome for various 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. Co-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 Alimentaire Tract (SSAT), DDW is a fully virtual meeting from May 21-23, 2021. The meeting features over 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.

The references:

  1. Centers for Disaster Control and Prevention. What is C. Diff? December 17, 2018. Available on: https://www.cdc.gov/cdiff/what-is.html.
  2. Centers for Disaster Control and Prevention. Biggest Threats and Data, November 14, 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html.
  3. Centers for Disaster Control and Prevention. June 24, 2020. Available on: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
  4. Feuerstadt P et al. J Med Econ. 2020; 23 (6): 603-609.
  5. 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.
  6. Cornely OA et al. Treatment of the first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clinical infectious diseases. 2012; 55 (S2): S154–61.
  7. 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.
  8. Leong C, Zelenitsky S. Treatment strategies for Clostridium difficile infection. Can J Hosp Pharm. 2013; 66 (6): 361-368.



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