![]() Mild symptoms, which occur infrequently, can sometimes interfere with normal daily functioning. Symptoms can be mild, moderate or severe. IBS is a functional bowel disorder characterised by discomfort, pain and changes in bowel habits. 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. 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. 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 developed a proprietary platform that rationally identifies novel bacteria that have a precise and evolved therapeutic effect. Limited - Joint Brokerįounded 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. Zeus Capital Limited - Nomad and Joint Brokerīryan Garnier & Co. 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.”įor further information please contact: 4D IBS remains an area of significant unmet need, with existing treatments limited to symptom management and many patients struggling to achieve relief. 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. A range of secondary efficacy endpoints will also be assessed, as well as the effects of Blautix on the gut microbiome.ĭr. 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. Up to 500 patients will receive either Blautix or placebo daily for 8 weeks. The Company has consulted with the FDA on the design of the study. 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 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. 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). ![]() First Patient Enrolment in Blautix IBS Phase II Study
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