4D pharma plc (AIM: DDDD), a pharmaceutical company focusing on the development of live biotherapeutics, today provides the following update on the phase 1 clinical trial in respect of Blautix, its proprietary single strain live biotherapeutic for the treatment of 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. Alteration of the microbiome of IBS patients is a recognised feature of the disease, and many patients have a microbiome that is more unstable and less diverse than that of healthy individuals.
Blautix is the Company's first orally delivered, single strain live biotherapeutic to undergo a clinical trial. As previously reported, the primary objective of the study was met, demonstrating that Blautix was safe and well tolerated. Furthermore, the Company reported trends indicating that IBS subjects receiving Blautix showed greater levels of symptom relief than those receiving placebo. The Company has now completed further analysis of patient samples, showing the positive impact of Blautix on the stability and diversity of the microbiome.
Throughout the trial, analysis of both healthy volunteer and IBS patient microbiomes was performed prior to dosing, after dosing and following a washout period. The analysis looked at both the stability and diversity of the microbiome, both of which are typically reduced in IBS patients compared to healthy volunteers. IBS patients receiving Blautix showed an increase in microbiome diversity and microbiome stability that was comparable to healthy controls. Conversely, as expected, IBS patients receiving placebo showed a reduction in microbiome diversity and exhibited microbiome instability over the period of the trial. This result may be indicative of a relevant therapeutic effect of Blautix and will be investigated further in phase II clinical studies scheduled for 2017.
Dr. Alex Stevenson, 4D's Chief Scientific Officer, commented: "Reduction in the stability and diversity of the microbiome is a recognised aspect of IBS pathophysiology. These results demonstrate that Blautix, our single strain live biotherapeutic for the treatment of IBS, is able to increase the stability and diversity of the microbiome in IBS patients. In addition to the previously reported results, this finding is very encouraging for the future clinical development of Blautix and our other single strain live biotherapeutic products."