Search Share Prices
4d Pharma submits new IBS drug application to FDA
AIM-quoted pharmaceutical company 4d Pharma has submitted an investigational new drug application for Blautix, its live biotherapeutic for the treatment of irritable bowel syndrome, to the US Food and Drug Administration.
4d has consulted with the FDA on the design of the study, which will see up to 500 patients receive either Blautix or a placebo on a daily basis for eight weeks, the primary endpoint of which will be to see an improvement in abdominal pain and stool frequency or consistency for at least four of those weeks.
The double-blind, placebo-controlled multicentre Phase II study will evaluate the efficacy and safety of Blautix in patients with IBS, in the form of constipation and diarrhoea.
A range of secondary efficacy endpoints will also be assessed, as well as the effects of Blautix on the gut microbiome.
Dr Alex Stevenson, 4d's chief scientific officer, said, "We are delighted to advance Blautix into this important proof-of-concept study, which brings us another step closer to bringing a novel treatment regime to patients."
"IBS is poorly addressed with current therapies, which only target the symptoms of the disease rather than tackling the underlying causes. By targeting the microbiome, Blautix has the potential to make a real difference for patients and could represent a new era in the treatment of IBS," Stevenson added.
Enrolment in the Phase II study was expected to begin during the second half of 2018.
As of 0900 BST, 4d shares had grown 4.25% to 135.00p.