4D Pharma plc LON:DDDD a pharmaceutical company focusing on the development of live biotherapeutics, announced today that it has commenced dosing in a phase 1 clinical trial for the treatment of Irritable bowel syndrome (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 patients 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.
The clinical trial will assess the safety and tolerability of Blautix in a number of healthy volunteers and individuals with IBS. In addition, clinical symptoms and biomarkers relevant to the mechanism of action of Blautix will be assessed. The trial is expected to be completed in late 2015.
Dr. Alex Stevenson, 4D pharma plc Chief Scientific Officer said: “Having obtained regulatory and ethical approval for the Blautix clinical trial, dosing of the first subjects represents an important milestone in the development of the Live Biotherapeutics class. Blautix has been designed to treat the underlying cause of IBS, rather than just the symptoms and we look forward to assessing its effects in a clinical setting.”