7th Oct 2020 11:25
(Alliance News) - 4D Pharma PLC on Wednesday reported "encouraging" topline results from its Phase II BHT-II-002 trial of Blautix, a single strain live biotherapeutic for the treatment of irritable bowel syndrome.
The Leeds-based pharmaceutical company said it investigated the effect of Blautix on both bowel habit and pain. It also assessed the treatment across both forms of irritable bowel syndrome, IBS-C and IBS-D, highlighting that Blautix has the potential to treat both major subtypes of the disease, unlike other approved products which act only on symptoms associated with either subtype of IBS.
4D Pharma stated results from the trial showed Blautix resulted in a statistically significant increase in overall response in pre-planned analysis of the combined IBS-C/D group compared to placebo, adding that the safety profile of the drug was comparable to the placebo. A total of 58 adverse events were recorded in 177 - or 33% - of subjects compared to 68 adverse events in 188 subjects receiving the placebo.
"The Phase II results provide signals that are highly encouraging and supportive of regulatory engagement around the design of a Phase III pivotal study to provide new therapeutic options to cover the considerable unmet medical need of people suffering from IBS," said Chief Scientific Officer Alex Stevenson.
4D Pharma said it is currently undertaking further analysis of the study results, including investigation of sub-groups with signals of higher levels of overall response in order to define the future pivotal clinical development strategy.
Shares in 4D Pharma were trading 24% lower at 132.34 pence each on Wednesday morning in London.
By Ife Taiwo; [email protected]
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