DDDD.L Regulatory News (DDDD)

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 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."

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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 subject 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 subjects 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.