4D pharma gets OK for clinical trial of Thetanix

4D pharma, a London stock exchange-listed pharmaceutical company focusing on the development of live biotherapeutics, has obtained regulatory and ethical approval for a phase 1 clinical trial in respect of Thetanix.

The company on Wednesday said in an announcement that Thetanix, its programme for the treatment of Paediatric Crohn’s Disease was approved, and also the release of the drug product for the beginning of the trial.

As exlained by 4D, 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), 4D further explains, children with PCD often experience growth failure, malnutrition, pubertal delay and bone demineralisation.

Also, 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 start befhe company added that the trial would be conducted in two UK centers and, unusually for a phase I study, would only include PCD patients.

Dr Alex Stevenson, 4D’s Chief Scientific Officer said:

“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.”