4D Presents Phase Ib Clinical Data on Blautix

4D pharma plc

(the "Company" or "4D")

4D Presents Phase Ib Clinical Data on Blautix

4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of live biotherapeutics, today announced that data from the Company's completed Phase Ib double-blind placebo-controlled clinical study of Blautix, the Company's live biotherapeutic for the treatment of Irritable Bowel Syndrome (IBS), in healthy individuals and IBS subjects will be presented today in a poster session at the 2018 Digestive Disease Week meeting in Washington DC. The Company has previously announced the topline results from this study.

The data presented show that Blautix was safe and well tolerated. More IBS subjects who received Blautix (82%) showed an overall improvement in IBS symptom scores compared to subjects receiving placebo (50%), and Blautix treatment increased microbiota diversity and stability.

Dr. Alex Stevenson, 4D's Chief Scientific Officer, commented: "The data from this first clinical trial of Blautix has provided a strong foundation for further clinical development as we progress into larger studies. Following the clearing of our Investigational New Drug Application by the U.S. Food and Drug Administration, we are now working with clinical sites in the US and Europe to prepare for the commencement of the upcoming Blautix Phase II trial, which we will begin enrolling later this year."

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Please find a copy of the poster here: http://www.4dpharmaplc.com/application/files/9515/2770/6728/4D_DDW_2018.pdf

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 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 has completed a phase I study in Irritable Bowel Syndrome and has completed dosing in a phase I study in Paediatric Crohn's Disease. It currently has a pipeline of 13 pre-clinical programmes, covering disease areas such as cancer, poorly controlled asthma, autoimmune and CNS disease, and plans to commence four additional clinical studies in 2018.

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.

About Blautix

Blautix is a single-strain live biotherapeutic candidate in development for the treatment of IBS with constipation (IBS-C) and IBS with diarrhoea (IBS-D). The organism was originally isolated from a healthy individual and has a distinctive metabolism which utilises intestinal hydrogen as an energy source, reduces levels of hydrogen sulphide, and increases microbiota diversity and stability. Unlike existing therapies which only seek to address IBS symptoms, by targeting the microbiome Blautix has the potential to act directly on the underlying pathophysiology of disease to treat all IBS patients irrespective of traditional sub-types. 4D pharma is investigating Blautix in the treatment of patients with IBS-C and IBS-D in a Phase II study at sites across the UK, US and Europe.