RE: RNS7 Oct 2020 08:19
IBS is a common and important condition that can have a significant impact on patients' quality of life. The prospect of a treatment that could equally benefit both IBS-C and IBS-D with a strong safety profile is very compelling," said Prof. Eamonn Quigley, Head of Gastroenterology and Hepatology at Houston Methodist Hospital and the Study's Chief Investigator."I am impressed with the improvement in bowel habit that was observed for Blautix in both IBS-C and IBS-D in the current trial, and believe that it is deserving of further study as it could provide an attractive treatment option in the future."
"We are very pleased with the outcome of the Blautix Phase II study, demonstrating not only that Blautix has an effect in both IBS-C and IBS-D, but that it has a favourable safety profile. This is very relevant in a condition where all approved treatments only have activity in either IBS-C or IBS-D, and many have treatment-limiting side effects. Blautix could provide a highly differentiated option for patients and physicians," said Dr. Alex Stevenson, Chief Scientific Officer of 4D pharma.
"Uniquely for a single agent, th e Blautix Phase II study has generated combined data across both sub-types of IBS. The effect shown by Blautix across both sub-types indicates it may potentially provide a solution to IBS-M patients whose symptoms fluctuate between IBS-C and IBS-D. These patients, who account for around 30% of all IBS patients, currently have no approved treatment options. This reflects the broad potential of Blautix as a completely new, safe, flexible therapeutic approach to treating all forms of the condition. The Phase II results provide signals that are highly encouraging and supportive of regulatory engagement around the design of a Phase III pivotal study to provide new therapeutic options to cover the considerable unmet medical need of people suffering from IBS."
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