RE: Wont Be Long6 Oct 2020 09:21
Olderandwiser? news on Blautix were expected Q3, now can pop up anytime. releasing these words on the 30th (added below) and talking about a potential poor RNS is nonsense
"Developing a new approach to IBS
4D pharma is conducting the world's largest clinical trial of a Live Biotherapeutic to date with its Phase II trial of Blautix® for the treatment of irritable bowel syndrome (IBS).
In April, the Company announced the successful completion of an interim futility analysis of the trial on a total of 118 IBS-C (constipation-predominant) and 128 IBS-D (diarrhoea-predominant) patients. This pre-specified interim analysis was not designed to quantify interim results, only to demonstrate that the study was not futile with respect to the primary endpoint. The interim analysis achieved its limited objective, and 4D pharma was encouraged to continue the analysis of the full trial data.
Moreover, Blautix was shown to have a safety profile comparable to placebo, with 3% and 2% patient discontinuation due to adverse events in the Blautix® and placebo arms respectively, and mild or moderate adverse events reported in 24% of subjects for both Blautix® and placebo arms.
The trial has now completed enrolment of approximately 370 patients and 4D pharma expects to announce full topline results in the first few days in Q4. Blautix® has the potential to be the world's first disease modifying therapy for IBS, by treating the underlying microbiome cause of disease. "