Anatara Lifesciences (ASX:ANR) Announces Phase II GaRP-IBS Trial Results
Clinical Trial Outcomes
Anatara Lifesciences has completed Stage 2 of its GaRP-IBS Phase II trial. The primary efficacy endpoint, reduction in IBS-SSS compared to placebo, was not met despite a consistent and meaningful response during the trial.
Secondary Endpoints
The trial achieved statistical significance in the secondary endpoint of anxiety score improvement (P=0.034 at Week 8) and overall HADS score (P=0.025 at Week 8). Additionally, the secondary endpoint of IBS-Adequate Relief was highly significant at 10 weeks (P=0.004), indicating a greater number of responders compared to placebo.
Safety Profile
The analysis confirmed no safety concerns, with the GaRP product being well tolerated. No concerning safety signals were identified, supporting the product’s safety profile.
Future Directions
Anatara is considering future directions and commercial opportunities following the trial outcome. The company will also progress its anti-obesity project with ongoing pre-clinical studies and explore additional opportunities in gastrointestinal health.
Executive Comments
Dr David Brookes, Executive Chair, stated, “Not reaching significance for the primary efficacy endpoint in any quality trial has to be a real disappointment for all involved, as it is the common goal, however the trial has still delivered significant findings. While taking the opportunity to again thank participants and those involved in conducting the trial, it is important to consider the positive information and results obtained that can still be both clinically and commercially relevant. Anatara will work efficiently towards summarising the pre-clinical studies and the IBS trial findings for commercial discussions.”
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