LONDON (Alliance News) - 4D pharma PLC said Friday it will delay the dosing of patients in its Thetanix phase 1 trial due to "quality concerns" that have come to light at one of its supply partners, and was conducting an investigation into the concerns.
The pharmaceutical company said it was due to start dosing patients with the Thetanix drug, which is for the treatment of paediatric Crohn's disease, on March 1. However, due to the "quality concerns" thrown up at one of its supply partners during the manufacture of an additional batch of the drug, the company said it will delay dosing by approximately one month. It said the dosing of patients is expected to commence following an investigation.
4D pharma added it has completed recruitment for its Blautic phase 1 trial, for the treatment of Irritable Bowel Syndrome, and said further data from the trial, involving 56 healthy volunteers and IBS patients, will be available in April.
"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," said Chief Scientific Officer Alex Stevenson.
4D pharma shares were down 1.3% at 920.00 pence on Friday.
By Hannah Boland; hannahboland@alliancenews.com; @Hannaheboland
Copyright 2016 Alliance News Limited. All Rights Reserved.