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 programme for the treatment of Irritable Bowel Syndrome (IBS).
Following completion of recruitment in February, all trial patients have now completed all scheduled assessments. The Company is pleased to report that the trial has shown that Blautix is safe and well tolerated, achieving the primary objective of the trial.
The trial, involving 56 healthy volunteers and IBS patients, is providing clinical samples and data which will be used to support our understanding of the mechanism of action of Blautix and the effect of a live biotherapeutic on the microbiome. In addition, the samples and data the trial is providing will be used to aid our development of a diagnostic for IBS. The Company will report further on this over the coming weeks.
Duncan Peyton, the Company's Chief Executive Officer, commented: "This is a further step towards taking our pipeline, and live biotherapeutics as a class, to market approval. We have shown Blautix to be safe and well tolerated, which we have always believed would be a keystone to the field of live biotherapeutics. In addition, this trial is providing patient samples that will give the Company a better understanding of what is happening in IBS patients undergoing treatment with Blautix. We believe that this will not only help with the design of the next clinical protocol, but also identify patients who will benefit most from treatment with our live biotherapeutic products."