4D Pharma cleared for clinical trial on Crohn’s treatment

MANCHESTER bio-medical company 4D Pharma has received regulatory and ethical approval for a phase one clinical trial for Thetanix – a programme for the treatment of Paediatric Crohn’s Disease (PCD).

PCD is an chronic inflammatory bowel diseases which causes inflammation or swelling across the lining of the digestive tract.

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 trial of Thetanix, which received Orphan drug designation from the FDA in the US in September 2013, is expected to commence before the end of the year. The trial will be conducted in two UK centres and, unusually for a phase one study, will only include PCD patients.

4D’s chief scientific officer Dr Alex Stevensonsaid: “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.”