An Aberdeen pharmaceutical company has hailed a “true first” in its field following a successful trial of its drug for Irritable Bowel Syndrome (IBS).
4D Pharma, which bases its research facilities at the University of Aberdeen’s Foresterhill Campus, said its early stage phase 1 clinical trial of its Blautix treatment found it was both safe to administer and more successful than a placebo.
Although the main aim of the trial was to determine if the drug is safe, which was confirmed in an early report from 4D, further analysis of symptoms and samples recording during the trial was “encouraging” and provide a basis for progressing Blautix into larger clinical studies and further evaluation as a potential treatment for the disorder, the firm said.
IBS is an illness characterised by discomfort, pain and changes in bowel habits, affecting 10-15% of the population.
Blautix is the first orally delivered “live biotherapeutic” – which contains micro-organisms – to undergo a clinical trial, 4D said.
Duncan Peyton, the company’s chief executive, said: “This is a true first in the field of live biotherapeutics. 4D has been able to produce an orally delivered live biotherapeutic, and generate meaningful data surrounding mechanism of action, and safety and tolerability, with great efficiency.
“Whilst the primary rationale for the trial was safety and tolerability, and recognising that it is a phase 1 trial in a very limited number of subjects, the data trends towards the overall effectiveness of Blautix.
“This gives us confidence to progress to the next phase towards approval of a safe, effective treatment in IBS.”
He added: “What 4D has achieved to date is a direct result of incredible work of our people. I am excited by the prospects not only for Blautix, but also for our platform, our pipeline and the impact live biotherapeutics could have across the pharmaceutical industry.”
4D Pharma is part of a significant cluster of biotherapeutic research and companies established in the north-east. It grew out of GT Biologics, a spin-out of Aberdeen University’s Rowett Institute of Nutrition and Health.
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 on the alternative investment market (AIM) in February 2014. Risk investor Neil Woodford has a 24% stake in the firm.
Pre-tax losses at the firm – which does not yet generate revenue – rose to £10.1million for the year to the end of December 2015, compared to a £2.4million loss in the prior year. Research and development spending rose to £6.9million from £1.8million in the same period.
Yesterday the firm’s shares fell almost 9% despite the positive results.