4D Pharma reports positive trial results for IBS treatment
Drugmaker 4D pharma has reported positive progress in clinical trials for its Blautix live biotherapeutic for the treatment of irritable bowel syndrome (IBS).
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The phase 1 clinical trial started in August 2015 and is being conducted in both healthy volunteers and individuals exhibiting symptoms of IBS.
An interim report on the safety and tolerability of Blautix in healthy volunteers, who have received multiple doses of the drug, stated that the drug appears to be well tolerated, and that additional data obtained appears to support the pharmacological hypothesis for the product.
"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,” said Dr. Alex Stevenson, 4D's Chief Scientific Officer.
“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 also has a clinical stage programmes for 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, 4D said.