of data from five RBX2660 prospective studies is one of only four
abstracts to receive the coveted IDWeek 2021 Program Committee Choice
award for outstanding scientific research.
Ferring and Rebiotix will present new data showing an association between clinical outcomes and restoration of the microbiome
from the Phase 3 PUNCH CD3 trial on the effects of RBX2660 on deadly
antimicrobial resistance genes and the restoration of bile acid
composition, also will be presented.
Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today
announced they will present data from the clinical development program
for RBX2660, an investigational microbiota-based live biotherapeutic for
reduction of recurrent Clostridioides difficile (C. difficile) infection, as part of IDWeek 2021. The congress will take place virtually from September 29 – October 3, 2021.
the data include the first-time presentation of an analysis from five
prospective clinical studies, which represent the totality of this
comprehensive body of clinical evidence for a microbiota-based live
biotherapeutic. IDWeek acknowledged this presentation and its author,
Lindy L. Bancke, PharmD, Head of Clinical Development at Rebiotix, as
one of only four recipients of the 2021 Program Committee Choice award,
based on outstanding scientific research.
the company will present data demonstrating the association of RBX2660
in gut microbiome restoration and the impact of the decolonization of
deadly multi-drug resistant organisms.
data presentations at IDWeek will not only add to the growing body of
clinical evidence supporting RBX2660, but they bring together nearly a
decade of research that show exciting advancements in how RBX2660
clinical outcomes relate to microbiome composition,” said James P Tursi, M.D., Chief Scientific Officer, Ferring Pharmaceuticals U.S.
clinical development program for RBX2660 is the largest and most robust
ever conducted in the field of microbiome-based therapeutics for
recurrent C. diff infection, enrolling more than 1,000 patients to date and including two studies that followed patients for 24 months.
The details of the five abstracts being presented are as follows:
Presentation Title: Efficacy of lnvestigational Microbiota-Based Live Biotherapeutic RBX2660 in Individuals with Recurrent Clostridioidesdifficile Infection: Data from Five Prospective Clinical Studies Presenting Author: Lindy Bancke, PharmD, Head of Clinical Development, Rebiotix EMBARGOED UNTIL: Wednesday, September 29 at 8:00 AM EDT
Presentation Title: Antimicrobial
Resistance Genes were Reduced Following Administration of
Investigational Live Biotherapeutic RBX2660 to Individuals with
Recurrent Clostridioides difficile Infection Presenting Author: Heidi Hau, PhD, Director of Translational Biology, Rebiotix EMBARGOED UNTIL: Wednesday, September 29 at 8:00 AM EDT
Presentation Title: Treatment Success in Reducing Recurrent Clostridioides difficile Infection
with lnvestigational Live Biotherapeutic RBX2660 is Associated with
Microbiota Restoration: Consistent Evidence from a Phase 3 Clinical
Trial Presenting Author: Ken Blount, PhD, Chief Scientific Officer, Rebiotix and VP Microbiome Research, Ferring Pharmaceuticals EMBARGOED UNTIL: Wednesday, September 29 at 8:00 AM EDT
Presentation Title: Safety of lnvestigational Microbiota-Based Live Biotherapeutic RBX2660 in Individuals with Recurrent Clostridioides difficile Infection: Data From Five Prospective Clinical Studies Presenting Author: Tricia Braun, PharmD, Associate Director of Clinical Research, Rebiotix EMBARGOED UNTIL: Wednesday, September 29 at 8:00 AM EDT
Presentation Title: Rapid Restoration of Bile Acid Compositions After Treatment with RBX2660 for Recurrent Clostridioides difficile Infection-Results from the PUNCH CD3 Phase 3 Trial Presenting Author: Romeo Papazyan, PhD, Scientist, Ferring Research Institute EMBARGOED UNTIL: Wednesday, September 29 at 8:00 AM EDT
IDWeek 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 diagnosis6,7 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
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
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.
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.
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.
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.
Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
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.
Cornely OA, et al. Treatment of First Recurrence of Clostridium difficile Infection: Fidaxomicin Versus Vancomycin. Clinical Infectious Diseases. 2012;55(S2):S154–61.
Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
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.
Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.