4D Pharma announces encouraging first clinical trial of Blautix

The trial was a first in man study and, as previously reported by the company, Blautix was found to be both safe and well tolerated and achieved the primary objective of the trial.

4D said that while the trial was not designed to demonstrate efficacy, subject symptoms were monitored. In common with other IBS studies, a strong placebo response was noted.

However, following the dosing period, subjects treated with Blautix showed a greater response over placebo, with the majority reporting an overall improvement in their IBS symptoms.

The group said the findings of the first clinical trial were encouraging an provide a solid basis for progressing Blautix into larger clinical studies and further evaluation as a potential treatment for IBS.

Chief executive Duncan Peyton said: "Whilst the primary rationale for the trial was safety and tolerability, and recognising that it is a phase 1 trial in a very limited number of subjects, the data trends towards the overall effectiveness of Blautix. This gives us confidence to progress to the next phase towards approval of a safe, effective treatment in IBS.

“These results also give us confidence in our platform, the direct relevance of humanised models and the overall approach we have adopted across our pipeline for diseases such as cancer, multiple sclerosis and asthma. What 4D has achieved to date is a direct result of incredible work of our people.”

At 1010 BST, 4D shares were down 7.3% to 725p.