Ferring and Rebiotix will present new data showing an association between clinical outcomes and restoration of the microbiome
Research 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.
PARSIPPANY, N.J.-- September 24, 2021 -- 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.
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Notably, 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.
Additionally, 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.
“Our 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.
The 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 Clostridioides difficile 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