4D Pharma PLC (LON:DDDD) announced that testing of its IBS live biotherapeutics treatment Blautix has shown meaningful data surrounding mechanism of action, as well as safety and tolerability, with “great efficiency”.
The first in man study was the only orally delivered live biotherapeutic to have undergone a clinical trial.
Twice daily dosing of 24 healthy volunteers and 24 IBS subjects with either Blautix (16/24) or placebo (8/24) over a 14 day period, with a further washout period of 19-23 days.
In common with other IBS studies, the study noted a strong placebo response.
However, following the dosing period, subjects treated with Blautix showed a greater response over placebo, with the majority reporting an overall improvement in their symptoms.
A greater proportion of the Blautix treatment group also exhibited a reduction in hydrogen breath levels following dosing.
Although based on a relatively small sample size, this observation is in line with pre-clinical data and strengthens the evidence of the proposed mechanism of action for Blautix in the treatment of IBS, namely altering the patient’s microbiome – altering the body’s microbial make-up.
The results show that the treatment is able to successfully deliver a single strain live biotherapeutic to the gut.
4D said the findings of this first clinical trial were encouraging and provide a solid basis for progressing Blautix into larger clinical studies and further evaluation as a potential treatment for IBS.
"This is a true first in the field of live biotherapeutics. 4D has been able to produce an orally delivered live biotherapeutic, and generate meaningful data surrounding mechanism of action, and safety and tolerability, with great efficiency,” said chief executive Duncan Peyton.
"This gives us confidence to progress to the next phase towards approval of a safe, effective treatment in IBS."
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