4d Pharma PLC MHRA and HPRA clear Blautix Phase II study

TIDMDDDD

4d Pharma PLC

13 June 2018

4D pharma plc

(the "Company" or "4D")

MHRA and HPRA clear Blautix Phase II study

4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of live biotherapeutics, today announced that the Company has received clearance from the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Health Products Regulatory Authority (HPRA) to commence the Phase II study of Blautix, the Company's live biotherapeutic for the treatment of Irritable Bowel Syndrome (IBS), at sites in the UK and Ireland.

This follows an announcement made by the Company in May that the US Food and Drug Administration (FDA) had cleared the Company's Investigational New Drug application to commence the Phase II study at sites in the US. Enrolment in the study is expected to commence in the second half of 2018.

The double-blind, placebo-controlled multicentre Phase II study will evaluate the efficacy and safety of Blautix in patients with IBS with constipation (IBS-C) and IBS with diarrhoea (IBS-D). The Company has consulted with the FDA on the design of the study. Up to 500 patients will receive either Blautix or placebo daily for 8 weeks. The primary endpoint will be the Overall Response rate, defined as the proportion of patients reporting an improvement in their weekly cohort-specific symptoms (abdominal pain and stool frequency or consistency) for at least 4 out of 8 weeks. A range of secondary efficacy endpoints will also be assessed, as well as the effects of Blautix on the gut microbiome.

Dr. Alex Stevenson, 4D's Chief Scientific Officer, commented: "We welcome this development which illustrates the international breadth of the study, set to take place at more than 10 sites across the US, UK and Ireland. This will be the largest live biotherapeutic clinical trial conducted to date and reflects our commitment to generate robust clinical data in large, well-controlled studies, which are aligned with the expectations of the regulatory authorities. We look forward to commencing enrolment of this study shortly."

For further information please contact:

 
4D                                             + 44 (0)113 895 0130 
Duncan Peyton, Chief Executive Officer 
Zeus Capital Limited - Nomad and Joint Broker 
Dan Bate / Jordan Warburton                    [phone] 
Bryan Garnier & Co. Limited - Joint Broker     [phone] 
Dominic Wilson 
 Phil Walker 
 

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.

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June 13, 2018 02:01 ET (06:01 GMT)