4D pharma plc (AIM: DDDD), a pharmaceutical company focusing on the development of live biotherapeutics, today provides the following updates on Blautix, its proprietary programme for the treatment of Irritable Bowel Syndrome (IBS) and Thetanix, its proprietary programme for the treatment of Paediatric Crohn's Disease.
The Company is pleased to report that recruitment for the Blautix phase 1 trial has now been completed. It is hoped that further data from the trial, involving 56 healthy volunteers and IBS patients, will be available in April 2016.
The Thetanix phase 1 trial in Paediatric Crohn's Disease was scheduled to begin dosing on 1st March 2016. However, the Company has made the decision to delay the dosing of patients due to quality concerns that have come to light at one of our supply partners during manufacture of an additional batch of Thetanix. The decision to delay was taken as a precautionary measure. The Company is working to resolve this issue and dosing of patients is anticipated to commence after an investigation has taken place. This is anticipated to take around one month.
Dr. Alex Stevenson, the Company's Chief Scientific Officer commented: "Although we are eager to progress our phase 1 trial in Paediatric Crohn's Disease, we have taken the precautionary measure of delaying the dosing of patients until our investigation has been completed. Importantly all our other programmes are unaffected by this issue, and we remain on track to deliver new programmes into the clinic in 2016. Further, we are pleased to be able to report the completion of patient recruitment in the Blautix phase 1 trial, and we look forward to reporting further results of the trial over the coming weeks."