And it said the results provided a “strong foundation” for the continued development of the first drug with the potential to treat both major subtypes of the condition.
Researchers investigated the effect of 4D’s Blautix on both bowel habit and pain in both groups to garner what is called a composite response endpoint. They also assessed the treatment across both IBS-C (constipation-predominant) and IBS-D (diarrhoea-predominant) forms of IBS.
The read-out showed there was a statistically significant impact on the overall response in the combined IBS-C and IBS-D group. There was also a positive, but non-significant, increase in overall response in the separate IBS-C and IBS-D cohorts.
The data showed Blautix was well tolerated with a safety profile comparable to placebo.
One of the aims of 4D’s live biotherapeutic approach is to create treatments that have few if any side-effects, obviating one of the major hurdles to success.
The potential for Blautix to work across the two IBS strains is also key is also “very relevant”, according to Dr Alex Stevenson, 4D’s chief scientific officer.
He pointed out that all the current approved treatments only have activity in either IBS-C or IBS-D, and many had limiting side effects.
“Blautix could provide a highly differentiated option for patients and physicians,” he said in a statement.
Indeed it may potentially provide a solution to IBS-M patients whose symptoms fluctuate between constipation and diarrhoea.
Stevenson noted that phase II results provided signals that were both “highly encouraging and supportive” of regulatory engagement around the design of a phase III pivotal study.
No guidance was given as to when this regulatory “engagement” would begin or the timeframe for the final-stage clinical trial.
Stevenson went on to say the new therapeutic provided “options to cover the considerable unmet medical need of people suffering from IBS”.
4D’s work focuses on the emerging scientific area of the human microbiome (the bacteria that reside mainly in the gut) and how this complex ecosystem, tweaks it to impact the treatment of disease.
Its live biotherapeutics contain live organisms. The approach focuses on single bacteria strains to assess specific mechanisms of action targeting a defined disease pathway. As mentioned above, they are designed to be safe and well-tolerated, removing the side-effects of traditional pharmaceutical and biological drugs.