26th Feb 2016 07:00
4D pharma plc
(the "Company" or "4D")
Clinical Update
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."
For further information please contact:
4D | + 44 (0)113 895 0130 |
Duncan Peyton, Chief Executive Officer
| |
Zeus Capital Limited - Nomad and Broker | |
Dan Bate | +44 (0) 161 831 1512 |
Dominic Wilson | +44 (0) 0203 829 5000 |
About 4D
Founded in February 2014, 4D pharma is a world leader in the development of live biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacteria, that is applicable to the prevention, treatment or cure of a disease. 4D pharma has developed a proprietary platform, MicroRx, that rationally identifies novel bacteria with a precise and evolved therapeutic effect. All of 4D pharma's live biotherapeutic products are orally delivered single strains of bacteria that are naturally found in the healthy human gut. 4D pharma currently has a pipeline of 13 preclinical programmes, including disease areas such as rheumatoid arthritis, multiple sclerosis and cancer, and is currently conducting patient trials in Irritable Bowel Syndrome and Paediatric Crohn's Disease. The programmes in Paediatric Ulcerative Colitis and Paediatric Crohn's Disease have both been granted Orphan Drug Status by the FDA.
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