RE: £132k @ 90p19 Aug 2020 15:22
Results for MRx1234 IBS trials due anytime between now and end of September.
Fri, 17th Apr 2020 07:00
RNS Number : 9582J
4d Pharma PLC
Interim analysis of Blautix phase II study data
Indicates encouraging safety profile and non-futility of study
Leeds, UK, April 17, 2020 - 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces the key findings of a planned interim analysis in its BHT-II-0002 study in IBS.
BHT-II-0002 is 4D Pharma's phase II, randomized, double blind, placebo-controlled, multicentre study. It is evaluating the safety and efficacy of repeated oral doses of the company's Live Biotherapeutic, Blautix, in adult subjects with irritable bowel syndrome (IBS) subtypes IBS-C and IBS-D.
The BHT-II-0002 study interim analysis, aimed to support clinical and commercial development plans, has been conducted on a total of 246 IBS patients (118 IBS-C and 128 IBS-D). Data on around 78 additional patients who have all finished drug treatment and primary endpoint evaluations for all patients are expected to be included in the full study analysis and trial data. 4D Pharma expects to report on this full data set as planned in Q3 2020.