- 4D pharma has started dosing in a phase 1 clinical trial with Thetanix for the treatment of Paediatric Crohn's disease ('PCD').

PCD is a rare chronic inflammatory bowel disease that is caused by the malfunction of the immune system leading to 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.

Current treatment regimens focus on the induction of remission through the use of corticosteroids and biologics, with immunosuppressants and biologics used as maintenance therapies.

Whilst these treatments are capable of resolving symptoms, they do not address the underlying cause of the disease. Furthermore, long-term use may reduce the response rate over time and is also associated with serious side effects, such as the development of cancers and deleterious effects on children's growth and bone health. Up to 29% of children require surgery within 3 years of diagnosis of PCD.

Thetanix is a live biotherapeutic, a new class of regulated therapeutics using bacteria to treat or cure disease.

Thetanix is a bacteria that was isolated from the gut of a healthy human subject. The development of Thetanix as a therapeutic is based on over two decades of research into the interaction of this bacteria and the human gut. This work has demonstrated that Thetanix has a specific role in modulating the immune system and has anti-inflammatory properties. Thetanix received orphan drug designation from the FDA in October 2013.

The phase 1 trial of Thetanix has now commenced and the company is pleased to report that the first subject in the trial has been dosed.

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