4D Pharma irritable bowel treatment proves safe in clinical trial

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Sharecast News | 23 May, 2016

Updated : 13:14

Early clinical trials of 4D Pharma's treatment for irritable bowel syndrome (IBS) have successfully shown Blautix to be safe and well tolerated.

Blautix, which contains live bacteria, like all 4D's products, was delivered orally to 56 healthy volunteers and IBS patients.

Data from the trial will be used to improve 4D's understanding of the mechanism of action of Blautix and the effect of the 'live biotherapeutics', the bacteria's effect, has on the microbiome.

Live biotherapeutics is a new class of drugs, defined by the US drug regulator as biological products that contain a live organism, such as a bacteria, that are used in the prevention, treatment or cure of a disease.

4D's MicroRx platform identifies novel bacteria found in the healthy human gut that have a precise therapeutic effect, with 13 preclinical programmes in the pipeline.

Chief executive Duncan Peyton said the data will also help the design of the next clinical protocol and also identify patients who will benefit most from treatment with the live biotherapeutic products.

He added that the completion of the trial was an important step for the pipeline and for live biotherapeutics as a class.

"We have shown Blautix to be safe and well tolerated, which we have always believed would be a keystone to the field of live biotherapeutics."

Shares in 4D were up 12% to 930p by 1330 BST on Monday.

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