Anatara Lifesciences (ASX:ANR) has provided an update on the Gastrointestinal ReProgramming (GaRP) trial for IBS (Irritable Bowel Syndrome).
The company said that following the statistical analysis of the cohort of the initial 31 participants, it is encouraged to proceed with the ongoing trial and planning for Stage 2.
It said the Data Safety Monitoring Board (DSMB) reviewed the preliminary data and was satisfied the continuation of the current trial protocol was supported, noting the small data set.
Anatara executive chair Dr David Brookes said, ”While the Company emphasises that these are very limited numbers, we take reassurance from this preliminary analysis of the available data in continuing the GaRP-IBS trial.
"Continuation of the trial following this analysis is a crucial step towards the company’s goal of establishing a non-prescription, licensed product for the maintenance and restoration of the gastrointestinal tract lining and homeostasis of the microbiome.
"There is a need for such a product both as an adjunctive mainstream treatment and one that can be readily available for the many sufferers of gut disorders and non-specific symptoms. The next review point is the formal interim analysis on the completion by all participants of Stage 1 which is expected in a few months.
"The trial has been quite disjointed due to the Covid dynamics initially and then the need for changes to the protocol inclusion/exclusion criteria through the appropriate processes. This led to a group of participants with finalised locked data at a time when enrolments and randomisation to product are still occurring in the trial. It seemed prudent to consider the progress of the study given the protracted recruitment and the availability of data.
"Following advice from external statisticians and in consultation with the DSMB, a preliminary analysis has been done that will contribute to and be continued with the full interim analysis at the conclusion of Stage 1, at which time Anatara expects statistical detail to be available.
"The good safety and tolerance profile was anticipated given the GaRP formula is based on the combination and specialised coating of GRAS (FDA 'Generally Recognised as Safe') ingredients that are not associated with serious side-effects such as toxicity or bleeding mechanisms.“