4D pharma plc Announces Clinical Update for Blautix Phase II Study
First Patient Enrolment in Blautix IBS Phase II Study
LEEDS, United Kingdom, Nov. 08, 2018 (GLOBE NEWSWIRE) -- 4D pharma plc (AIM: DDDD), (the “Company” or “4D”) a pharmaceutical company leading the development of Live Biotherapeutics, is pleased to announce the randomisation of the first patient in a Phase II clinical trial of Blautix in patients with Irritable Bowel Syndrome (IBS). The study will recruit up to 500 patients at sites across the US and EU and is set to be the largest clinical trial of a Live Biotherapeutic conducted to date.
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/or 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 are delighted to have enrolled the first patient in this important study, which brings us another step towards making Blautix available for patients. IBS remains an area of significant unmet need, with existing treatments limited to symptom management and many patients struggling to achieve relief. By targeting the gut microbiome, Blautix targets the underlying pathophysiology of IBS and has the potential to fundamentally change the way these patients are treated.”
For further information please contact:
|4D||+44 (0)113 895 0130|
|Duncan Peyton, Chief Executive Officer|
|Zeus Capital Limited - Nomad and Joint Broker||+44 (0) 161 831 1512|
|Dan Bate / Jordan Warburton|
|Bryan Garnier & Co. Limited - Joint Broker||+44 (0)20 7332 2500|
|Dominic Wilson / Phil Walker|
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.
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.
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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