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4D Pharma upbeat on key findings from Blautix study
17th Apr 2020 13:53
(Sharecast News) - Biotherapeutics-focussed pharmaceutical company 4D Pharma announced key findings of a planned interim analysis in its 'BHT-II-0002' study in irritable bowel syndrome (IBS) on Friday.
The AIM-traded firm described BHT-II-0002 as its phase 2 randomised, double blind, placebo-controlled, multicentre study.
It said it was evaluating the safety and efficacy of repeated oral doses of its live biotherapeutic 'Blautix' in adult subjects with IBS subtypes IBS-C and IBS-D.
The BHT-II-0002 study interim analysis, aimed to support clinical and commercial development plans, was conducted on a total of 246 IBS patients, being 118 IBS-C patients and 128 IBS-D patients.
Data on around 78 additional patients who had all finished drug treatment, and primary endpoint evaluations for all patients, were expected to be included in the full study analysis and trial data.
4D Pharma said it expected to report on the full data set as planned in the third quarter.
The company said the interim analysis demonstrated that Blautix had a safety profile comparable to placebo, with 3% vs 2% patient discontinuation in the drug group compared to placebo due to adverse events.
There was one recorded severe adverse event in each arm, with no relation to study drug, and mild or moderate adverse events reported in 24% of subjects for both Blautix and placebo arms, indicating that the treatment had no increased adverse effects compared to placebo.
The interim analysis of the primary endpoint of the IBS study showed that the study was not futile, the board said, with the company "encouraged" to continue the analysis of the full trial data.
"The interim analysis of the Blautix phase II results in IBS is encouraging," said chief scientific officer Dr Alex Stevenson.
"IBS is a disease that causes significant morbidity and has a high unmet medical need."
Dr Stevenson said 4D Pharma had identified the potential of the live biotherapeutic Blautix as a new approach to treat IBS and address both IBS-C and IBS-D with the same therapy.
"The interim analysis supports and informs 4D Pharma's future development and commercialisation plans with partners."
At 1348 BST, shares in 4D Pharma were up 9.28% at 42.4p.
The AIM-traded firm described BHT-II-0002 as its phase 2 randomised, double blind, placebo-controlled, multicentre study.
It said it was evaluating the safety and efficacy of repeated oral doses of its live biotherapeutic 'Blautix' in adult subjects with IBS subtypes IBS-C and IBS-D.
The BHT-II-0002 study interim analysis, aimed to support clinical and commercial development plans, was conducted on a total of 246 IBS patients, being 118 IBS-C patients and 128 IBS-D patients.
Data on around 78 additional patients who had all finished drug treatment, and primary endpoint evaluations for all patients, were expected to be included in the full study analysis and trial data.
4D Pharma said it expected to report on the full data set as planned in the third quarter.
The company said the interim analysis demonstrated that Blautix had a safety profile comparable to placebo, with 3% vs 2% patient discontinuation in the drug group compared to placebo due to adverse events.
There was one recorded severe adverse event in each arm, with no relation to study drug, and mild or moderate adverse events reported in 24% of subjects for both Blautix and placebo arms, indicating that the treatment had no increased adverse effects compared to placebo.
The interim analysis of the primary endpoint of the IBS study showed that the study was not futile, the board said, with the company "encouraged" to continue the analysis of the full trial data.
"The interim analysis of the Blautix phase II results in IBS is encouraging," said chief scientific officer Dr Alex Stevenson.
"IBS is a disease that causes significant morbidity and has a high unmet medical need."
Dr Stevenson said 4D Pharma had identified the potential of the live biotherapeutic Blautix as a new approach to treat IBS and address both IBS-C and IBS-D with the same therapy.
"The interim analysis supports and informs 4D Pharma's future development and commercialisation plans with partners."
At 1348 BST, shares in 4D Pharma were up 9.28% at 42.4p.