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

Saint-Prex, Switzerland & Roseville, Minn., United States:   

  • 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.

“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.1,2,3C. difficile infection recurs in up to 35% of cases after initial diagnosis4,5 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.

Disclaimer: This content is distributed by Business Wire India.

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