Paris, November 6, 2023 - Exeliom Biosciences SAS is pleased to announce its collaboration with Hospices Civils de Lyon in a Phase 1/2 clinical trial to evaluate EXL01 (Faecalibacterium prausnitzii) as a preventive treatment for the recurrence of Clostridioides difficile (C.difficile) infection in high-risk patients.
Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is associated with a high risk of recurrence, estimated at close to 20% after a first episode and over 60% after two recurrences or in the case of specific risk factors. This clinical trial, LIVEDIFF, represents a crucial step in the development of EXL01, an innovative drug candidate developed by Exeliom Biosciences and based on intestinal microbiota to combat recurrences of C. difficile infection, as an alternative to fecal microbiota transplantation (FMT) currently recommended for these cases.
The LIVEDIFF clinical trial will be conducted under the auspices of the Hospices Civils de Lyon, which has submitted an application for authorization to conduct a clinical trial in France to the Agence Nationale de Sécurité du Médicament and the Comité de Protection des Personnes. The study centers will open their doors in the first half of 2024.
EXL01 is an orally-administered biotherapeutic product containing a unique, unmodified strain of the dominant commensal bacterium Faecalibacterium prausnitzii. The first phase of the study is designed to demonstrate the safety and tolerability of EXL01 in patients at high risk of recurrence previously treated with vancomycin. The second phase will assess EXL01's efficacy in preventing C.difficile recurrence after 8 weeks.
Dr. Nicolas Benech, MCU-PH at Hospices Civils de Lyon, and coordinating investigator of the study, expresses his enthusiasm by declaring: "EXL01 constitutes a treatment with very promising therapeutic prospects for restoring an altered intestinal ecosystem and preventing the recurrence of C. difficile infection. Recurrent C. difficile infections affect over 10,000 patients in Europe, with less than 10% having access to fecal microbiota transplantation, the reference treatment in this case. The evaluation of EXL01 in this indication represents a major step forward in the development of effective, accessible and reproducible microbiota-based therapies".
"We are delighted to join forces with such a prestigious hospital as the Hospices Civils de Lyon to evaluate the potential of EXL01 as an alternative to reference treatment. We would particularly like to underline the remarkable commitment and efficiency of the Clinical Research Center at the Croix-Rousse Hospital in developing and implementing the project. This collaboration marks a key moment in our commitment to developing innovative solutions for patients at high risk of C.difficile infection. We believe that EXL01 can offer a more controlled and reproducible large-scale approach than fecal microbiota transplantation, and we look forward to contributing to the advancement of healthcare," says Benjamin Hadida, CEO & Co-founder of Exeliom Biosciences.
This study also has the support of the French Ministry of Health and Prevention via PHRC-interregional funding obtained this year.
ABOUT EXL01
EXL01 is an orally administered biotherapeutic product containing a unique, unmodified strain of the dominant commensal bacterium Faecalibacterium prausnitzii. EXL01 has immunomodulatory properties that enable synergistic effects when combined with standard therapies in a range of indications. EXL01 is currently being evaluated in Crohn's disease patients in a Phase 1 clinical trial (https://clinicaltrials.gov/ct2/show/NCT05542355). Faecalibacteriumprausnitzii has also been identified as a key marker of response to checkpoint inhibitors in a number of publications. In preclinical models, EXL01 has demonstrated its ability to stimulate response to existing anti-PD1/PD-L1 therapies.
ABOUT HOSPICES CIVILS DE LYON
The Hospices Civils de Lyon comprises 13 public hospitals, all with a triple mission: care, research and teaching.
Together, we form a community of 24,000 men and women, caregivers and non-caregivers, who share a single vocation: to care for every patient, whatever their situation and pathologies, throughout their lives.
From the management to the treatment of diseases (from the most benign to the rarest),and in conjunction with all the healthcare players in the Lyon area, we place research at the heart of our approach to respond to today's medical advances and anticipate tomorrow's therapeutic challenges. As France's second-largest university hospital center, we support and train the medical and non-medical staff of tomorrow through our 11 schools and institutes.
ABOUT EXELIOM BIOSCIENCES
Exeliom Biosciences is a biotechnology company specializing in thedevelopment of new generations of microbiome-derived immunotherapies. Its mission is to bring innovation to the pharmaceutical treatment of chronic inflammatory bowel disease, cancer and infectious diseases. Its lead compound,EXL01, an oral biotherapeutic, is in clinical development for the treatment of Crohn's disease, and will soon be evaluated in three combination trials in immuno-oncology, as well as in a trial for recurrent C. difficile infections.
The company was founded in 2016 in Paris and Dijon (France) by a renowned scientific team comprising Prof. Harry Sokol (Professor of Gastroenterology, Hôpital Saint Antoine in Paris), Dr. Philippe Langella (Director of Research at INRAe) and Prof. Patrick Gervais (Professor of Process Engineering at AgroSup), who were the first to demonstrate and publish the properties of Faecalibacteriumprausnitzii back in 2008.
For more information on Exeliom Biosciences, please visit www.exeliombio.com.
Contacts :
Exeliom Biosciences
Benjamin Hadida - Co-founder and CEO
