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4D pharma clinical update on IBS treatment

19 January 2016 07:47

Interim data from a clinical trial on Blautix, 4D pharma's proprietary live biotherapeutic for the treatment of irritable bowel syndrome (IBS), indicates it appears to be well tolerated.

The company commenced a phase 1 clinical trial of Blautix in August. The trial is being conducted in both healthy volunteers and individuals exhibiting symptoms of IBS.

The company has received an interim report regarding the safety and tolerability of Blautix in healthy volunteers, who have received multiple doses of the drug product.

The company says it is pleased to report that the drug appears to be well tolerated, and that additional data obtained appears to support the pharmacological hypothesis for Blautix.

4D's chief scientific officer, Dr. Alex Stevenson, said: "Although this is interim data, these results indicate that Blautix appears to be safe and well tolerated in healthy volunteers. We look forward to reporting further results from the trial shortly, when dosing in IBS patients is completed. We believe our approach of identifying and developing novel live biotherapeutic products from healthy human samples gives us an advantage in terms of safety, and also allows us to rapidly develop drug candidates for diseases where current treatments may be associated with severe side effects."

4D has two clinical stage programmes; Blautix, for the treatment of IBS, and Thetanix, for the treatment of Paediatric Crohn's Disease.

The company has successfully developed MicroRx, its proprietary platform for the discovery of novel live biotherapeutics from its proprietary strain library of over 2,500 bacteria. Since May 2014, the MicroRx platform has generated 12 programmes in autoimmune, cancer and CNS disease areas. As all live biotherapeutics discovered via MicroRx originate from healthy human samples, they are expected to have improved safety profiles over current treatments, such as small molecules and other biologics such as antibodies.

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