The company has randomized the first patient of the mid-stage trial which will assess the efficacy and safety of Blautix in patients having IBS with constipation (IBS-C) and/or IBS with diarrhoea (IBS-D).
4D pharma will recruit up to 500 patients at clinical trial sites across the US and the European Union (EU). The company claims the phase 2 study of Blautix to be the largest clinical trial of a live biotherapeutic till date.
As per its consultations with the US Food and Drug Administration (FDA), the trial will see the patients subjected to either Blautix or placebo daily for a duration of eight weeks.
The primary endpoint of the phase 2 trial will be the overall response rate, which is the proportion of patients reporting an improvement in their weekly cohort-specific symptoms such as abdominal pain and stool frequency or consistency, for at least four out of eight weeks of treatment.
The trial will also assess various secondary efficacy endpoints along with the effects of Blautix on the gut microbiome.
According to 4D pharma, Blautix was originally isolated from a healthy individual. The live biotherapeutic candidate is said to have a unique metabolism, which uses intestinal hydrogen as an energy source. Through this metabolism, the organism helps in lowering hydrogen sulphide levels and improves microbiota diversity and stability.
4D pharma claims that Blautix, which targets the microbiome, has the potential to directly act on the underlying pathophysiology of disease for the treatment of all IBS patients of any traditional sub-types.
In May 2018, 4D pharma released data from a phase Ib double-blind placebo-controlled clinical trial of Blautix, which showed the live biotherapeutic candidate to be safe and well tolerated. Further, 82% of IBS patients treated with it showed an overall improvement in IBS symptom scores compared to patients subjected to placebo (50%).
4D pharma chief scientific officer Alex Stevenson said: “We are delighted to have enrolled the first patient in this important study, which brings us another step towards making Blautix available for patients.
“IBS remains an area of significant unmet need, with existing treatments limited to symptom management and many patients struggling to achieve relief. By targeting the gut microbiome, Blautix targets the underlying pathophysiology of IBS and has the potential to fundamentally change the way these patients are treated.”