One of Aberdeen’s largest pharmaceutical companies has called a temporary halt to a clinical trial while it investigates “quality concerns” over its new drug for Crohn’s disease.
4D Pharma, which bases its research facilities at the University of Aberdeen’s Foresterhill Campus, said it has delayed the phase 1 trial for its Thetanix drug, which was set to be tested on live patients in the UK next week.
The new drug is aimed at treating Paediatric Crohn’s Disease (PCD). Crohn’s is a chronic inflammatory bowel disease that causes swelling, across the lining of the digestive tract. Up to one in five Crohn’s sufferers show symptoms before they are 20 years old, which raises risk of growth failure, malnutrition, delayed puberty and bone thinning.
The firm said the trial delay was taken as a “precautionary” measure after “concerns” emerged during manufacture of an additional batch of the drug. It expects the investigation to take about a month.
Last year, the company highlighted that the trial was “unusual” in that it would include only young patients with the disease.
Dr Alex Stevenson, the company’s Chief Scientific Officer said: “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.”
He added that the company’s trial of another drug, Blautix, for the treatment of Irritable Bowel Syndrome (IBS), has completed. The company said it will reveal the results of the trial in the next few weeks.
4D Pharma grew out of GT Biologics, a spin out of Aberdeen University’s Rowett Institute of Nutrition and Health, led by gut immunology expert, Professor Denise Kelly.
Aquarius Equity Partners took an initial stake in GT Biologics in 2012, after which its name was changed to 4D Pharma.
The Leeds-based private equity firm, which specialises in life sciences, floated 4D the Alternative Investment Market (AIM) in February 2014, in a £16.6million IPO. The company joined the marked valued at £36.5million and has since rocketed to be worth 15 times more, almost £565million.
4D bought out the remaining investors in GT Biologics last year, paying £1.22million for a 16.5% stake.