4D pharma secures approval for Phase 1 trial of Crohn’s disease drug

Thetanix is designed to treat paediatric Crohn’s disease (PCD), which is a chronic inflammatory bowel disease that causes inflammation, or swelling, across the lining of the digestive tract, resulting in growth failure, malnutrition, pubertal delay and bone demineralisation.

4D pharma will undertake the phase 1 trial of Thetanix in two UK centers. The study is expected to start before the end of this year.

4D pharma chief scientific officer Alex Stevenson 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."

The US Food and Drug Administration granted orphan drug designation to Thetanix in September 2013. It is expected that there are about 41,000 children in the US with PCD.

4d pharma focuses on the development of several projects targeting important new therapeutic areas.

Earlier this year, 4D pharma entered into a €4.8m four-year collaboration project with the APC Microbiome Institute at University College Cork in Ireland.

The project will focus on the research of the potential applications of live biotherapeutics in relation to autism spectrum disorders and associated CNS disorders.