Business Wire

Ferring Presents Complete Data across Five RBX2660 Trials Demonstrating Consistent and Durable Efficacy in Recurrent C. Difficile Infection, as Well as Multiple Analyses Demonstrating Positive Shifts in Microbiome Properties

Share

Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today announced final results of an analysis from five prospective trials of its investigational microbiota-based live biotherapeutic, RBX2660, for the reduction of recurrent C. difficile infection (rCDI). The abstract, presented at IDWeek 2021, represents the first time these data are showcased together, and is one of only four abstracts to receive the Program Committee Choice award for outstanding scientific research.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210929005597/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Ferring IDWeek Infographic

“For years, people with recurrent C. difficile infection haven’t had an available, standardized treatment option to break the cycle of recurrence or clinically address the health of their gut microbiome composition that puts them at risk for this highly communicable disease, and they still do not,” said Teena Chopra, MD, MPH, Professor of Medicine, Division of Infectious Disease, Wayne State University School of Medicine. “The important data from the Ferring microbiome-based biotherapeutic trials provide a significant milestone for the C. difficile community to hopefully one day have an improved treatment option for patients suffering from this disease.”

Across the five prospective trials, which included 723 actively-treated participants, RBX2660 consistently reduced the recurrence of CDI, with up to 78.9% remaining recurrence-free for eight weeks post treatment (defined as treatment success). Among participants who did not respond to initial treatment, an optional additional treatment course was administered, resulting in overall rates of treatment success of up to 84.4%. Notably, most primary responders remained CDI-free for six months and up to two years, with a sustained clinical response success rate of up to 92.1% in the Phase 3 program.

“These data provide the totality of evidence culminating in over a decade’s worth of work that demonstrates a consistent efficacy profile for RBX2660, and importantly, a consistent safety profile across five prospective trials,” saidLindy L. Bancke, PharmD, Head of Clinical Development at Rebiotix, who presented the research. “They reinforce the enormous potential of microbiome-based therapeutics to transform the care of people suffering from rCDI.”

This analysis included three Phase 2 (PUNCH CD, PUNCH CD2, PUNCH CD Open Label) and two Phase 3 trials (PUNCH CD3, PUNCH CD3-OLS ad hoc analysis). All participants were ages 18 or older who had at least one recurrence after a primary episode of CDI and had completed at least one round of standard-of-care oral antibiotic therapy. According to a separate presentation on safety, RBX2660 demonstrated a consistent safety profile across all five clinical studies. The percentage of participants reporting a treatment-emergent adverse event (TEAE) in the RBX2660 group was similar to the group receiving the standard-of-care plus placebo. Most TEAEs were mild or moderate in severity, and no potentially life-threatening TEAEs were considered related to RBX2660.

A third abstract showed that, among treatment responders in the PUNCH CD3 trial, RBX2660 significantly increased gut bacteria associated with health and decreased gut bacteria associated with CDI pathology within seven days, maintaining that effect for up to six months following treatment. Specifically, RBX2660 demonstrated an increase in the relative abundance of two important classes of beneficial bacteria – Bacteroidia and Clostridia – and reduced relative abundance of classes that could be considered harmful, Gammaproteobacteria and Bacilli.

“C. difficile infection often is marked by a vicious cycle of recurrence, wherein patients’ infection may return within days after antibiotic treatment. This can significantly impact a person’s health and well-being, and burden the healthcare system,” said Ken Blount, PhD, Chief Scientific Officer at Rebiotix and a study presenter. “The shift of the microbiome observed in our study provides the first evidence linking Phase 3 efficacy data of RBX2660 with improved microbiota composition of the gut. This finding is important, as this is during a time when a person recovering from CDI is most vulnerable for reinfection, and these changes were durable for at least six months.”

Additional evidence from the PUNCH CD3 trial, presented in two separate abstracts, demonstrated important potential benefits that may contribute to the therapeutic efficacy seen in the clinical program. In the trial, RBX2660 appeared to remove potentially deadly antimicrobial resistant (AMR) bacteria from the gut microbiota, as researchers found that the total number of AMR genes in participants receiving RBX2660 decreased significantly after treatment and remained low for at least six months. Colonization of AMR pathogens in the gut is a known risk factor for infection and common among people with recurrent CDI. The PUNCH CD3 analysis also showed that RBX2660 treatment responders exhibited reduction in primary bile acids, known to trigger CDI spore germination, and increase secondary bile acids, known to inhibit spore germination and growth.1

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).2 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.2,3,4

C. difficile infection often is the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.5,6 Up to 35% of CDI cases recur after initial diagnosis7,8 and people who have had a recurrence are at significantly higher risk of further infections.9,10,11,12 After the first recurrence, it has been estimated that up to 60% of patients may develop a subsequent recurrence.13

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.14 The use of antibiotics has been shown to disrupt the ecology of the gut microbiome and are a predominant risk factor for rCDI.7,8,14

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

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. 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. 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 MRTTM 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 IDWeek

IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). More information can be found at www.idweek.org.

References:

  1. Winston, Jenessa A, and Casey M Theriot. “Impact of microbial derived secondary bile acids on colonization resistance against Clostridium difficile in the gastrointestinal tract.” Anaerobe vol. 41 (2016): 44-50. doi:10.1016/j.anaerobe.2016.05.003
  2. Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
  3. Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html.
  4. Fitzpatrick F, Barbut F. Breaking the cycle of recurrent Clostridium difficile. Clin Microbiol Infect. 2012;18(suppl 6):2-4.
  5. Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
  6. Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
  7. 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.
  8. Cornely OA, et al. Treatment of First Recurrence of Clostridium difficile Infection: Fidaxomicin Versus Vancomycin. Clinical Infectious Diseases. 2012;55(S2):S154–61.
  9. Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
  10. 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.
  11. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.
  12. Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
  13. Leong C, Zelenitsky S. Treatment strategies for recurrent Clostridium difficile infection. Can J Hosp Pharm. 2013;66(6):361-368.
  14. 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.
  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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Heather Levis Guzzi
Director, Brand Communications
P: +1 862-286-5254
E: Heather.Guzzi@ferring.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Janssen Receives Positive CHMP Opinion for RYBREVANT ® (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy15.10.2021 18:30:00 CEST | Press release

FOR EU TRADE AND MEDICAL MEDIA ONLY. NOT TO BE DISTRIBUTED TO UK AND BENELUX BASED MEDIA The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product amivantamab, intended for the treatment of adult patients with advanced NSCLC with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy.3 If approved, amivantamab will be the first treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for advanced NSCLC.1 “This group of patients often face a poor prognosis as there are currently no targeted therapy options for this specific mutation nor does it typically respond to existing therapies used to treat more common EGFR mutations,” 1,4,5 commented Catherine Taylor, M.D., Vice President, Medical Affairs

Leading Researchers Present 24-Plex Digital PCR Assay and Novel Multiplex Applications Uniquely Enabled by Stilla’s 6-Color naica ® system15.10.2021 15:08:00 CEST | Press release

Stilla Technologies, the multiplex digital PCR company, joined researchers from SAGA Diagnostics in presenting a 24-plex digital PCR assay generated on Stilla’s six-color naica® system. To mark the platform’s global commercial launch at the American Society of Human Genetics (ASHG) 2021 Virtual Meeting, Stilla’s Cofounder and Chief Technology Officer Rémi Dangla, PhD, and researchers from SAGA Diagnostics, Fred Hutchinson Cancer Research Center, and University of Athens highlighted the new data during a discussion on how highly sensitive, multiplex digital PCR technology is transforming complex genomic data into actionable insights across a breadth of research and clinical applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211015005140/en/ Stilla’s six-color naica® system, the industry’s first six-color digital PCR system, answers market needs for higher performance and multiplexing technology. Learn more here: www

Boston Metal Wins S&P Global Platts Global Metals Award15.10.2021 15:04:00 CEST | Press release

Boston Metal won the New Technology for the Metals and Mining Industry award at the 2021 S&P Global Platts Global Metals Awards. Boston Metal is commercializing ground-breaking technology to decarbonize primary steelmaking. The company’s technology combines patented innovations with best practices from the aluminum and steel industries to deliver a revolutionary solution to the carbon emissions challenge facing the steel value chain. Powered by renewable electricity, molten oxide electrolysis converts iron ore into liquid metal and oxygen. The modular, scalable platform produces no CO2 emissions, is highly energy efficient, and works with a wide range of iron ore grades. “We congratulate all the winners and finalists for persevering through unique challenges and continuing to drive performance while embracing change,” said Saugata Saha, president of S&P Global Platts. Dave Ernsberger, Global Head of Pricing and Market Insight, S&P Global Platts, said: “Not surprisingly, but certainly e

The Ministry of Justice makes public the evidence supporting of the Republic of Kazakhstan’s case against Anatolie and Gabriel Stati15.10.2021 13:46:00 CEST | Press release

The Ministry of Justice has launched a new website to spotlight evidence gathered by the Republic of Kazakhstan regarding the fraud committed by Anatolie and Gabriel Stati: www.kzarbitration.com. The purpose of the website is to present the facts of the ongoing and complex legal case and provide easy access to the corresponding evidence. This public repository will increase transparency around the case and dispel the disinformation and lies perpetrated by these individuals against the Republic of Kazakhstan and its people. The evidence - in the form of court rulings, expert opinions, and other publicly available documents - confirms that the Statis have been engaged in a complex and multi-faceted fraud since at least 2006. The website explains how Anatolie and Gabriel Stati defrauded international investors of their money, falsified financial statements, fraudulently obtained audit opinions and pursued an international arbitration against the Republic of Kazakhstan to recoup from the S

TP Awards Schlumberger Sakarya Offshore Gas Field Phase-1 Contract15.10.2021 13:00:00 CEST | Press release

Schlumberger announced today a significant contract award by Turkish Petroleum (TP) for the engineering, procurement, construction and installation (EPCI) of end-to-end production solutions for the Sakarya gas field, Turkey’s largest gas reserve. The contract is awarded to Schlumberger and Subsea 7, as part of a consortium. The integrated project scope will cover subsurface solutions to onshore production, including well completions, subsea production systems (SPS), subsea umbilicals, risers, flowlines (SURF), and an early production facility (EPF). Schlumberger will deliver the well completions scope and the design, construction, and commissioning of the early production facility capable of handling up to 350 MMscfd of gas. The SPS and SURF scope will be delivered by OneSubsea®, the subsea technologies, production, and processing systems division of Schlumberger, and Subsea 7. “Schlumberger is uniquely positioned to integrate solutions from the subsurface to the processing facility, a

2021 Jeonju Bibimbap Festival Kicks Off Under the Theme of 'World Bibim Week'15.10.2021 09:00:00 CEST | Press release

Jeonju, a UNESCO Creative City of Gastronomy, announced that the 2021 Jeonju Bibimbap Festival, the typical gourmet festival of the city, is to be held on every weekend during October 9 - 31, 2021 in the vicinity of Jeonju Hyanggyo in Jeonju Hanok Village and online. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211015005015/en/ UNESCO Creative City of Gastronomy Jeonju city has opened the 2021 Jeonju Bibimbap Festival. Under the title of World Bibim Week, this year's festival is designed and supervised by Ryu Jae-hyeon, Executive Director, focusing on a food festival to deliver the best taste while promoting sociability that is represented by ‘mixture’. It is to be held on every weekend during October 9 - 31, 2021 in the vicinity of Jeonju Hyanggyo in Jeonju Hanok Village and online. The four week-festival features ‘day’ programs on each weekend under different themes including Bibim Week (Day for Couples), Vitamin Week (D

Announcing the 2021 .eu Web Awards Winners!15.10.2021 09:00:00 CEST | Press release

Last night the 2021 .eu Web Awards ended in epic fashion at the Teatro Antico in Taormina, Italy. Hosted by EURid, the .eu Web Awards are a competition for the best .eu, .ею and .ευ websites. After last year’s virtual only event, we were pleased to once again celebrate the finalists and winners in person. View the hybrid event here. Hosted by Sally Bundock, esteemed journalist for BBC world news, the gala night brought us sincere joy reflected by the winners, combined with amazing performances by featured artists like THePETEBOX, Women Orchestra, MM Dance Company, Compagnia Joculares and the GAP’s Orchestra. The magical event ended with fireworks. “Being able to see real faces and raw emotion conveyed by the guests again made the night unforgettable” noted Giovanni Seppia, EURid’s External Relations Manager. “This is what the Web Awards is all about, bringing together people from various industries and backgrounds and honouring them for having chosen a .eu for their online presence.” P

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom