4D pharma plc (AIM: DDDD), a pharmaceutical company focusing on significant new therapeutic areas, provides the following research update on Blautix™ for the treatment of Irritable Bowel Syndrome ("IBS") and Thetanix™ for the treatment of Paediatric Crohn's Disease ("PCD").
Following the recent award of an FDA orphan designation for Rosburix for the treatment of paediatric ulcerative colitis, 4D continues to make significant progress with its other development programmes. Both Blautix, a treatment for IBS, and Thetanix, a treatment for PCD, are now anticipated to enter clinical studies in Q2 2015. It is currently intended that these studies would be primarily concerned with evaluating safety and tolerability of the products. Additionally, some clinical effects of the treatments would be assessed in PCD patients (in relation to Thetanix) and in healthy volunteers and a small number of symptomatic IBS individuals (in relation to Blautix). Both treatments are live biotherapeutics, using live bacteria as the drug as opposed to the more traditional approach of chemical entities or biologics such as antibodies.
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.
PCD is a chronic inflammatory bowel disease that causes inflammation, or swelling, across the lining of the digestive tract. Crohn's disease most often affects the end of the small intestine but can happen anywhere along the digestive tract from mouth to anus. In addition to gastro intestinal symptoms (diarrhoea, rectal bleeding, abdominal pain), children with PCD often experience growth failure, malnutrition, pubertal delay and bone demineralisation. Approximately 20% of patients with Crohn's disease present when they are younger than 20 years and it is estimated that there are around 41,000 children in the USA with PCD.
Treatment options depend on severity. Corticosteroids, immunomodulators and anti-TNF therapies are often used, but have been linked to a variety of side effects ranging from infection to certain cancers. Surgery may also be necessary for some children.
Dr. Alex Stevenson, 4D's Chief Scientific Officer commented: "The Blautix and Thetanix trials will represent important milestones for the Company and a new class of therapeutic, designed to treat the underlying causes of diseases rather than just the symptoms. In addition, 4D continues to generate a strong pipeline of live biotherapeutics for other important diseases, using its proprietary MicroRx platform."