4D pharma plc (AIM: DDDD), a pharmaceutical company focusing on the development of live biotherapeutics, today provides the following update on the development and first clinical trial of its proprietary diagnostic platform, MicroDx.
MicroDx has been designed to diagnose, stratify and monitor the treatment of patients based on their gut microbiome, the bacteria which colonise the human gastro-intestinal tract. 4D has developed a strategy to identify bacteria in the gut to allow for diagnosis of disease which, when combined with the therapeutics developed by 4D, may provide for efficient and effective options for clinicians, patients and payers.
Importantly, MicroDx is able to identify 'signatures' based on the functionality of the gut microbiome, and also on metabolite profiles (small molecules produced by the microbiome). This advance by 4D will allow the development of rapid methods of diagnosis, that could be readily transferred into the clinical setting.
Running concurrently with the development of Blautix, 4D's first live biotherapeutic development programme, the first clinical trial of MicroDx is being carried out in Irritable Bowel Syndrome (IBS). IBS is a functional bowel disorder characterised by discomfort, pain and changes in bowel habits, affecting 10-15% of the population. It is subdivided into constipation (C), diarrhoea (D) and mixed (M) subtypes. All subtypes are represented in the 80 IBS subjects in the MicroDx trial.
Interim analysis of data generated in the MicroDx clinical study has revealed the following:
· There are significant differences between the microbiota profiles of IBS patients and healthy subjects
· The microbiota of IBS clinical subtypes are not significantly different, supporting the rationale for Blautix as a therapy for all IBS subtypes
· MicroDx is able to differentiate IBS patients from healthy subjects based on metabolite profiles.
Duncan Peyton, 4D's Chief Executive Officer, commented: "Companion diagnostics have long been associated with helping to provide more accurate and effective treatment outcomes. Advances in the understanding of the interaction of our microbiome and disease are leading not only to new discoveries and possibilities in therapeutics, as we have shown with our MicroRx platform, but also in how we diagnose and treat disease. The early clinical results from our MicroDx platform are very promising. The exceptional efforts of our team have potentially opened the way for a point of care diagnostic for IBS, and provided the means to monitor our therapeutic intervention Blautix, our clinical stage programme for the treatment of IBS. Moving forward, we will be incorporating MicroDx into our upcoming live biotherapeutic clinical studies in cancer and severe asthma, planned for later this year."