Glasgow life sciences business MGB Biopharma has confirmed that its lead anti-bacterial agent, MGB-BP-3, is now being tested in patients for the first time. The Phase II study will focus on people diagnosed with C.diff-associated disease, a serious and sometimes life-threatening condition linked to antibiotic use and hospital-acquired infection. The firm described the move into patient dosing as a major step in the development of its pipeline, following earlier funding and pre-clinical work to prepare the drug for trial.
The trial is designed to evaluate the safety and tolerability of MGB-BP-3 as well as its efficacy, with a particular emphasis on improving sustained cure rates in C.diff. Around 30 patients in North America are expected to take part, providing early clinical data on how the drug performs in a real-world hospital setting. MGB Biopharma has said the study will look closely at overall clinical outcomes, reflecting an unmet need for treatments that can both clear infection and reduce the risk of recurrence.
Mr Paul Goldsmith MD, FRCS, Consultant General Surgeon at Manchester University NHS Foundation Trust and Chief Investigator of the RISE study, said: “IBS-C can be a highly burdensome condition, with many patients continuing to experience abdominal pain, bloating and constipation despite available treatment options. EBX-102-02 represents a novel investigational approach that is designed to modulate the gut microbial ecosystem, which is increasingly recognised as an important area of interest in IBS. The RISE study builds on encouraging Phase 2a clinical signals and will help evaluate whether this approach can deliver meaningful benefit for patients living with IBS-C.”
Professor Yan Yiannakou, Consultant Neurogastroenterologist at County Durham and Darlington NHS Foundation Trust, said: “There is growing evidence that disruption of the gut microbiome plays an important role in the pathophysiology of IBS-C. While existing therapies can improve symptoms for some patients, many continue to experience a substantial burden of disease and remain dissatisfied with available treatment options. EBX-102-02 represents a fundamentally different therapeutic approach, seeking to address dysfunction in the gut microbial ecosystem rather than only stimulate bowel activity. The RISE study is therefore an important clinical trial, and its results will be of considerable interest to clinicians and patients.”
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Dr James McIlroy, Chief Executive Officer of EnteroBiotix, said, “Dosing the first patient in RISE is an important step towards evaluating the potential of EBX-102-02 to address the underlying biology of IBS-C. The trial reflects our commitment to building a leading position in full-spectrum microbiome therapeutics for high-burden gastrointestinal diseases. We are grateful to the patients, investigators and clinical teams supporting the study and look forward to advancing this important programme.”
MGB Biopharma’s progress comes against the backdrop of growing investment and activity in Scotland’s wider life sciences ecosystem, which includes microbiome-focused firms such as EnteroBiotix that are advancing therapies for conditions including irritable bowel syndrome, liver cirrhosis and blood cancers. These companies are building manufacturing and laboratory capacity across the Central Belt, positioning Scotland as a hub for advanced therapeutics and translational research. Combined with public backing from bodies such as the Scottish National Investment Bank, the sector is aiming to deliver globally competitive innovation from a Scottish base.
