LONDON (Alliance News) - Biotherapeutics developer 4D Pharma PLC said on Tuesday that the US Food & Drug Administration has cleared the Investigational New Drug Application for irritable bowel syndrome treatment, Blautix.
The company will now conduct enrolment for the drug's Phase Two study, expected to take place in the second half of 2018. The double blind, placebo-controlled study will evaluate the efficacy and safety of Blautix in patients with irritable bowel syndrome who have constipation and diarrhoea.
Up to 500 patients will receive Blautix or a placebo daily for eight weeks, with the primary endpoint being the overall response rate, defined as the proportion of patients reporting an improvement in their weekly cohort-specific symptoms for at least four out of eight weeks.
"Despite affecting up to 15% of the population, and a market forecast to be worth more than USD2.5 billion by 2024, 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," said 4D Pharma Chief Scientific Officer Alex Stevenson.
Shares in 4D Pharma were up 2.7% at 133.00 pence on Tuesday.