its here7 Oct 2020 08:04
4D pharma announces topline results from Blautix® Phase II trial in irritable bowel syndrome (IBS)
Positive trends seen in primary efficacy endpoint of the study of overall response in both IBS-C and IBS-D subgroups
Statistically significant impact on overall response in combined IBS-C and IBS-D group
Blautix® was well tolerated, with a safety profile comparable to placebo
Phase II trial results provide strong foundation for the continued development of the first therapeutic with potential to treat both major subtypes of IBS
Leeds, UK - October 7, 2020 - 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces encouraging topline results from its Phase II BHT-II-002 trial of Blautix®, a single strain Live Biotherapeutic to treat irritable bowel syndrome (IBS).
Consistent with FDA guidance on the clinical evaluation of treatments for IBS, 4D pharma plc ('4D') investigated the effect of Blautix® on both bowel habit and pain as a composite response endpoint. 4D pharma also investigated the treatment across both IBS-C (constipation predominant) and IBS-D (diarrhoea predominant) clinical subtypes, as Blautix® has potential to treat both major subtypes of the disease, unlike other approved products which act only on symptoms associated with either subtype of IBS.
The Phase II trial showed that Blautix® treatment resulted in:
· A statistically significant increase in overall response in pre-planned analysis of the combined IBS-C/D group compared to placebo;
· A positive, though non-significant, increase in overall response in both IBS-C and IBS-D cohorts;
· Safety profile of Blautix® was comparable to placebo, contrasting with many existing therapies which have significant side effect profiles limiting their utility; and
· Positive data trends in population sub-groups within both disease subtypes that warrant further analysis and investigation.
The results of the study demonstrated that Blautix® has levels of activity in both IBS-C and IBS-D that are comparable to other drugs approved solely in either indication. The randomised Phase II study was designed to generate data to guide the pivotal development phase of the Blautix® program and the results shown give the Company confidence and the necessary data for the design of a Phase III pivotal programme.
The commercial opportunity provided by Blautix® could be substantial, given the need for a safe and effective treatment across IBS-C and IBS-D populations.
"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 fo
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