Pediatric Crohn's Disease (PCD) Trial

[xeridea]

Want to get this on folks' radars. 4D Pharma is set to start trials in 2015 for Thetanix, a bacterial recolonization treatment specifically targeting Pediatric Crohn's Disease. I can't find too much information other than these might be Phase 1/2 trials for safety and tolerability.

The premise of their treatment is "... re-colonisation of a naturally occurring gut micro-organism and stabilization of the normal gut microbiota, can potentially modify the course of the disease, decreasing the major symptoms and providing a revolutionary step forward in the treatment of Paediatric Crohn’s disease."

http://www.ft.com/cms/s/0/0ab91b92-32ad-11e4-93c6-00144feabdc0.html

From what I can find, Thetanix is based on bacteroides thetaiotamicron, a gram-negative anaerobic microbe. It's an interesting bacteria as it is an actor in the human-bacterial symbiosis realm. It's is a player in the development of the intestinal mucosal barrier, and its interactions with Paneth cells contribute to nutrient absorption.

I wish I had more details on the study but thought this is appropriate for this sub-forum since it's a therapy that specifically targets kids.

Also this is a UK based company. Not sure if the trials will be multi-center or limited to UK/Europe.

 

[DustyKat]

This is the only additional information I could find at this point xeridea:

The pharmaceutical company 4D Pharma has announced the start of two new clinical trials during the second quarter of 2015, which are planned to test novel treatments for irritable bowel syndrome (IBS) and pediatric Crohn’s disease (PCD). Blautix and Thetanix are both biotherapeutics created based on live bacteria and not chemicals and antibodies, as are found in current medications.

The clinical trial of Blautix, a treatment for IBS, and Thetanix, a treatment for PCD, is going to focus primarily on evaluating the safety and tolerability of the products. Further studies are, however, planned to assess its clinical effects on PCD patients, healthy volunteers, and symptomatic IBS patients, respectively.

“The Blautix and Thetanix trials will represent important milestones for the company and a new class of therapeutic, designed to treat the underlying causes of diseases rather than just the symptoms. In addition, 4D continues to generate a strong pipeline of live biotherapeutics for other important diseases, using its proprietary MicroRx platform,” said the chief scientific officer of 4D, Alex Stevenson.

The news of the schedule for next years’ clinical trials follows a recent orphan drug designation granted by the U.S. Food and Drug Administration (FDA) to Rosburix, another 4D Pharma treatment, indicated to treat pediatric ulcerative colitis.

According to 4D, between 10 and 15 percent of the population suffers from IBS, and only a third seeks medical help. Although there are approved treatments, all are focused on reducing the burn of the symptoms instead of treating the disease itself. Pediatric Crohn’s disease, on the other hand, affects about 41,000 children in the U.S. alone, and is a chronic bowel disease that causes inflammation across the lining of the digestive tract, as well as diarrhea, rectal bleeding, and abdominal pain. In children, it may also cause growth failure, malnutrition, pubertal delay, and bone demineralisation.

http://ibdnewstoday.com/2014/09/03/4d-pharma-to-begin-trials-on-two-novel-ibs-and-pediatric-crohns-disease-treatments-next-year/

 

[AZMOM]

I'm so glad you posted this!

 

[xeridea]

Want to get this on folks' radars. 4D Pharma is set to start trials in 2015 for Thetanix, a bacterial recolonization treatment specifically targeting Pediatric Crohn's Disease. I can't find too much information other than these might be Phase 1/2 trials for safety and tolerability.

The premise of their treatment is "... re-colonisation of a naturally occurring gut micro-organism and stabilization of the normal gut microbiota, can potentially modify the course of the disease, decreasing the major symptoms and providing a revolutionary step forward in the treatment of Paediatric Crohn’s disease."

http://www.ft.com/cms/s/0/0ab91b92-32ad-11e4-93c6-00144feabdc0.html

From what I can find, Thetanix is based on bacteroides thetaiotamicron, a gram-negative anaerobic microbe. It's an interesting bacteria as it is an actor in the human-bacterial symbiosis realm. It's is a player in the development of the intestinal mucosal barrier, and its interactions with Paneth cells contribute to nutrient absorption.

Just saw this report that they've delayed start of Phase 1 by about month as a precaution to investigate possible quality issues from one of their suppliers.