23 May 2016 07:00
4D pharma plc
(the "Company" or "4D")
Clinical Update
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."
For further information please contact:
4D | + 44 (0)113 895 0130 |
Duncan Peyton, Chief Executive Officer
| |
Zeus Capital Limited - Nomad and Broker | |
Dan Bate | +44 (0) 161 831 1512 |
Dominic Wilson | +44 (0) 203 829 5000 |
About 4D
Founded in February 2014, 4D is a world leader in the development of live biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacteria, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform, MicroRx, that rationally identifies novel bacteria that have a precise and evolved therapeutic effect. All of 4D's live biotherapeutic products are orally delivered single strains of bacteria that are naturally found in the healthy human gut. 4D currently has a pipeline of 13 preclinical programmes, covering disease areas such as rheumatoid arthritis, multiple sclerosis and cancer, and is currently conducting patient trials in Irritable Bowel Syndrome and Paediatric Crohn's Disease. The programmes in Paediatric Ulcerative Colitis and Paediatric Crohn's Disease have both been granted Orphan Drug Status by the FDA.
About IBS
IBS is a functional bowel disorder characterised by discomfort, pain and changes in bowel habits. Symptoms can be mild, moderate or severe. Mild symptoms, which occur infrequently, can sometimes interfere with normal daily functioning. Moderate symptoms are more intense, occur more frequently, and often interfere with daily functioning. Severe symptoms chronically interfere with daily functioning. It is estimated that 10-15% of the population have IBS, with only 30-35% of patients seeking medical attention, the majority of which have persistent symptoms. There are currently few approved treatment options, all of which focus on the modulation of symptoms.