EnteroBiotix Ltd.

EnteroBiotix Completes Phase 2 Study Recruitment of EBX-102-02 in Irritable Bowel Syndrome 122 patients with moderate to severe irritable bowel syndrome (IBS) were recruited to EnteroBiotix’s Phase 2 TrIuMPH trial assessing EBX-102-02 EnteroBiotix completed enrolment ahead of its planned schedule, dosing 62 participants with constipation predominant IBS (IBS-C) and 60 participants with diarrhoea predominant IBS (IBS-D) Topline data expected to readout in Q1 2025 18 November 2024. EnteroBiotix Limited (‘EnteroBiotix’ or the ‘Company’), a clinical-stage biotechnology company focussed on developing best-in-class full-spectrum microbiome therapeutics, today announced the completion of recruitment in its Phase 2 TrIuMPH (Treating IBS with an Intestinal Microbiota Product for Health) trial assessing the safety, tolerability and efficacy of EBX-102-02, the Company’s lead asset, for the treatment of patients with Irritable Bowel Syndrome (IBS). The randomised, double-blind, placebo-controlled Phase 2 TrIuMPH trial enrolled a total of 122 patients at two sites in the UK. Patients with confirmed severe IBS-C or IBS-D using Rome IV criteria were randomised 2:1 to receive EBX-102-02 or placebo at two timepoints one week apart and were followed up over a six-week period. The study’s primary objective is to evaluate the safety and tolerability of EBX-102-02 in patients with severe IBS. Secondary objectives included assessing efficacy, changes in gut microbiome composition and function and relevant biomarkers. Dr James McIlroy MBChB, CEO of EnteroBiotix, commented: "We are grateful to the trial participants and investigators for helping us advance EBX-102-02 so expeditiously. Reaching this milestone ahead of schedule highlights the dedication of our clinical team and our partnership with the Functional Gut Clinic. The rapid enrolment reflects patient interest and the significant need for innovative IBS therapies that target microbiome imbalances, and we look forward to reporting topline data early next year.” EnteroBiotix is a clinical-stage biotechnology company developing therapeutics to treat gastrointestinal and hepatic diseases. EnteroBiotix’s therapies contain highly diverse ecosystems of microorganisms stabilised using proprietary platform technology and designed to improve gut health by augmenting the gut microbiome. EnteroBiotix has completed enrolment of patients in a Phase 2 double-blind, placebo-controlled, multi-centre clinical study in irritable bowel syndrome (IBS) and is progressing a Phase 2a study with Imperial College in patients undergoing allo-HSCT. The Company recently announced positive results in a Phase 1b clinical study of its full-spectrum product EBX-102 in patients with liver cirrhosis, demonstrating proof-of-principle across multiple microbiome assessments, inflammatory biomarkers and clinical assessments, supporting its continued development as the first microbial therapy for individuals with liver disease. EBX-102-02 is a next-generation, full-spectrum drug candidate that contains highly diverse microbial ecosystems and key functional groups that restore and fortify the microbiome. The drug is presented as an easy to take capsule with demonstrated stability at ambient temperature. TrIuMPH (Treating IBS with an Intestinal Microbiota Product for Health) is a randomised, double-blind, placebo-controlled Phase 2 trial designed to evaluate the safety and tolerability of EBX-102-02, EnteroBiotix’s next-generation, full-spectrum microbiome drug candidate, in patients with irritable bowel syndrome (IBS). A total of 122 participants with IBS were recruited to TrIuMPH at two sites. 62 participants with constipation predominant IBS (IBS-C) and 60 participants with diarrhoea predominant IBS (IBS-D) were dosed with EBX-102-02 or matching placebo and followed up for six weeks. Irritable bowel syndrome (IBS) is a chronic relapsing functional gastrointestinal (GI) disorder, with patients experiencing a range of symptoms, such as chronic abdominal pain, cramping, bloating and change in bowel movements – which may include constipation, diarrhoea, or both. It is estimated that up to 1 in 8 people suffer from IBS type symptoms, and there is approximately an equal split between patients experiencing predominantly constipation (IBS-C) versus diarrhoea (IBS-D) pattern. In the United States, direct medical costs associated with IBS are estimated to be as high as $10b annually, with indirect costs as high as $20b (Nellesen et al. 2013). The Functional Gut Clinic (FGC) is the UK’s leading independent provider of gastrointestinal physiology testing and diagnostics. FGC provides both private and NHS services around the UK and is the only independent GI physiology clinic to have Improving Quality in Physiological Services (IQIPS) / United Kingdom Accreditation Services (UKAS) and Care Quality Commission (CQC) accreditation. Established in 2013, FGC has an extensive R&D and Clinical trials portfolio helping to design and test future digestive health tests and treatments. The content above comes from the network. if any infringement, please contact us to modify.

EBX-102 demonstrated proof-of-principle across multiple microbiome assessments, inflammatory biomarkers and clinical assessments, supporting its continued development as the first microbial therapy for individuals with liver disease Glasgow, Scotland – 11 November 2024. EnteroBiotix Limited (‘EnteroBiotix’ or the ‘Company’), a clinical-stage biotechnology company focussed on developing best-in-class full-spectrum microbiome therapeutics, today announced positive results from its Phase 1b IMPuLCE study evaluating EBX-102 in patients with liver cirrhosis. EnteroBiotix’s first-in-human study of EBX-102 was a randomised, double-blind, placebo-controlled Ph1b study of adult participants with stable liver cirrhosis. It was designed to evaluate the safety, tolerability, and translational biomarker effects of two different doses of EBX-102. The study was conducted across ten sites in the United Kingdom. Participants were followed up for 12 weeks after dosing. Dr James McIlroy MBChB, CEO of EnteroBiotix, said: “We wish to thank the participants and the investigators for making this study possible and for their contributions to enable the development of EBX-102. In addition to safety and tolerability data supporting further studies, we observed multiple microbiome and systemic measurements supporting mechanistic proof-of-principle. There are very large unmet medical needs in the field of advanced liver disease, and it is greatly encouraging that EBX-102 has potential efficacy in this population.” Data highlights: EBX-102 was well tolerated with an acceptable safety profile. The commonest adverse events were gastrointestinal, and mainly mild and self-limiting. No serious treatment emergent adverse events were reported.Participants receiving the higher dose of EBX-102 in Cohort 2 showed significant shifts in stool bacterial microbiome composition compared to placebo, assessed by 16SrRNA sequencing.Participants receiving EBX-102 showed statistically significant changes to stool bacterial metabolites. Shotgun sequencing is ongoing and will provide additional insights into engraftment.Venous ammonia concentrations remained stable in all study participants, whereas there was a statistically significant increase in stool ammonia concentrations in the treatment groups but not the placebo group. This suggests a shift towards enhanced ammonia excretion through the stool rather than absorption into the bloodstream.A reduction in plasma lipopolysaccharide-binding protein (LBP) was observed in the drug cohorts but not in the placebo. This may indicate successful modulation of the gut microbiota towards a more beneficial ecology, improved gut barrier integrity, and a reduced inflammatory response.An improvement in hospital anxiety and depression scores were observed in the treatment groups but not in the placebo group, with a stronger trend at the higher dose, indicating potential gut-brain-axis effects. Professor Ewan Forrest, Chief Investigator of the IMPuLCE study and Honorary Professor, School of Cardiovascular & Metabolic Health at the University of Glasgow commented: “These exciting data demonstrate that EBX-102 is well tolerated in patients with chronic liver disease, showing promising biological effects that strongly support further clinical development. The observed improvement in mental health scores is particularly intriguing, and we look forward to continuing to explore the potential of EBX-102 in future liver disease trials.” About EBX-102 EBX-102 is an encapsulated full-spectrum microbiome therapeutic with differentiated characteristics, such as consistency, high-bacterial diversity, and stability. EnteroBiotix has platform manufacturing technologies and a well-developed analytical toolkit that enable the scalable manufacture of EBX-102. The Company controls the supply chain for its products through sophisticated MHRA-licensed manufacturing infrastructure together with its Number 2® brand, which ensures the safety, security, quality, and sufficiency of supply of microbiota obtained from healthy human donors. About EnteroBiotix EnteroBiotix is a clinical-stage biotechnology company developing therapeutics to treat gastrointestinal and hepatic diseases. EnteroBiotix’s therapies contain highly diverse ecosystems of microorganisms stabilised using proprietary platform technology and designed to improve gut health by augmenting the gut microbiome. EnteroBiotix is currently enrolling patients in a Ph2 double-blind, placebo-controlled, multi-centre clinical study in irritable bowel syndrome (IBS) and is progressing a Ph2a study with Imperial College in patients undergoing allo-HSCT. Media contacts EnteroBiotixDr James McIlroy MBChB, CEOinfo@enterobiotix.com ICR HealthcareNamrata Taak, Kris Lamenterobiotix@ICRHealthcare.com

European Microbiome Innovation for Health and Microbiome Therapeutics Innovation Group Announce New Collaboration Agreement Paris, France, September 23, 2024, 2:00 pm CET - The European Microbiome Innovation for Health (EMIH) association today announced an agreement between the Microbiome Therapeutics Innovation Group (MTIG) and EMIH for a collaboration to advance microbiome drug development, explore synergies between international regulators, and convene cross-continental meetings to incorporate the perspectives of a wide-range of drug developers. This new collaboration will incorporate diverse perspectives with the goal of further accelerating microbiome therapeutic product development to expand availability of life-changing and life-saving regulatory approved microbiome therapies to patients. A main priority of the agreement is to harmonize regulatory frameworks from multiple regions to create a more cohesive approach in seeking the necessary policy and regulatory solutions for the issues faced by MT drug developers. “MTIG’s founding principal is to accelerate patients’ access to innovative microbiome therapeutics through our communal efforts,” said Dr. Nikole Kimes, Chairman of MTIG and CEO of Siolta Therapeutics. “The EMIH represents innovative microbiome companies aligned with this core mission, and we look forward to sharing insights with one another to amplify our collective voice and transform the lives of patients on both sides of the Atlantic.” Hervé Affagard, President of EMIH and CEO and co-founder of MaaT Pharma, stated "As leading associations in the microbiome field, we understand that our strength lies in collaboration. By joining forces with MTIG, we will accelerate the development and delivery of microbiome therapies, ensuring that groundbreaking treatments reach those who need them most, swiftly and safely. This partnership embodies our shared commitment to harmonizing regulatory frameworks, and we look forward to working closely with MTIG." EMIH and its members are dedicated to advancing knowledge and fostering the development of bioproductions, diagnostics, and medical devices based on the microbiome for human health. The organization is committed to ensuring equitable access to these innovations by adhering to regulatory frameworks that uphold the highest quality standards, while maintaining an economic balance to support ongoing therapeutic innovation. All pharmaceutical and biotechnology companies seeking regulatory approvals in Europe for microbiome bioproductions, diagnostics, and medical devices are eligible for membership consideration in EMIH. If you are interested in learning more, please contact EMIH here. About The Microbiome Therapeutics Innovation Group The Microbiome Therapeutics Innovation Group (MTIG) is a coalition of companies leading the research and development of FDA-approved microbiome therapeutics and microbiome-based products to address unmet medical needs, improve clinical outcomes, and reduce health care costs. The human microbiome is one of the new frontiers of medical innovation that has the potential to benefit patients suffering from numerous diseases afflicting millions of patients and consuming billions of dollars of healthcare resources. MTIG is committed to working with stakeholders who share in our mission and seek tangible policy and regulatory solutions in the emerging microbiome arena. Through a collective voice, the MTIG membership works together to enhance the regulatory, investment, and commercial environment to accelerate microbiome therapeutic product development and enable the field to reach its potential to benefit patients. Today, MTIG is comprised of eleven microbiome therapeutics companies: BiomeSense, Biose Industrie, Freya Biosciences, MaaT Pharma, Microba Life Sciences, Rebiotix Inc., a Ferring Company, Seres Therapeutics, Siolta Therapeutics, and Vedanta Biosciences. For more information, visit www.microbiometig.org About European Microbiome Innovation for Health The European Microbiome Innovation for Health (EMIH) is an independent coalition within the European Union, the United Kingdom, and Switzerland, currently comprising 20+ major players from the public and private sectors. From the laboratory to the patient’s bedside, EMIH covers the entire value chain of the microbiome industry. Its goal is to position Europe as a global leader in the development, production, and commercialization of microbiome-based therapeutic innovations. EMIH members include Bioaster, Biocodex, BioGaia, Biofortis, Biose Industrie, Eligo Bioscience, GMT Science, INRAe, Lallemand Health Solutions, Life Avocats, Enosis Santé, EnteroBiotix, Pelican Health, MaaT Pharma, mbiomics, Microbiotica, Microbiome Foundation, MRM Health, Nexbiome, Novobiome, Seventure Partners and SwipeBiome. For more information, please visit www.europeanmicrobiome.org Contact for European Microbiome Innovation for Health Email: p.richaud@europeanmicrobiome.org Attachment EMIH MTIG PR Final_240923