4D pharma plc (AIM: DDDD), a pharmaceutical company focussing on the development of live biotherapeutics, announced today that it has obtained regulatory and ethical approval for a phase 1 clinical trial in respect of Thetanix™, its programme for the treatment of Paediatric Crohn's Disease ("PCD"), and release of the drug product for commencement of the trial.
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 occur anywhere along the digestive tract from mouth to anus. In addition to gastrointestinal 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 United States with PCD.
The phase 1 trial of Thetanix™, which received Orphan drug designation from the FDA in September 2013, is expected to commence before the end of 2015. The trial will be conducted in two UK centres and, unusually for a phase I study, will only include PCD patients.
Dr Alex Stevenson, 4D's Chief Scientific Officer commented: "Obtaining regulatory and ethical approval and product release for the Thetanix™ trial are key milestones in the clinical trial process. We look forward to commencing the trial in line with our anticipated timeline, and assessing Thetanix™ and its effects in a clinical setting."