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Highlights
- Phase II trial for GaRP-IBS did not meet primary endpoint
- Positive results seen in key secondary measures
- Product showed strong safety profile with no concerns
Anatara Lifesciences (ASX:ANR) has announced the results of Stage 2 of its Phase II clinical trial for GaRP-IBS, its investigational treatment targeting Irritable Bowel Syndrome (IBS). While the trial did not meet its primary efficacy endpoint—reduction in the IBS Symptom Severity Score (IBS-SSS) compared to placebo—it revealed encouraging outcomes in other clinically relevant areas, particularly in secondary endpoints and safety.
The primary goal of the study was to demonstrate a statistically significant improvement in IBS-SSS compared to the placebo group. Despite a consistent and meaningful patient response, the data did not reach the threshold of statistical significance. However, this outcome has not overshadowed the promising findings within the trial’s secondary metrics.
Statistically significant improvements were observed in several secondary measures, indicating that GaRP-IBS may have a role to play in improving overall patient wellbeing. Notably, anxiety scores improved significantly (P=0.034) at Week 8, along with a statistically meaningful change in the overall Hospital Anxiety and Depression Scale (HADS) score (P=0.025). One of the standout results was in the measure of IBS-Adequate Relief, where a significantly higher number of participants reported meaningful symptom relief at Week 10 compared to the placebo group (P=0.004).
On the safety front, GaRP-IBS was well tolerated by participants. The product showed no safety concerns or adverse signals during the trial, reinforcing confidence in its safety profile. This clean safety slate is a critical factor when evaluating any potential new therapeutic, especially in gastrointestinal health, where treatment tolerability is essential.
Following these findings, Anatara Lifesciences is evaluating next steps and commercial pathways. While the company navigates the outcomes of this trial, it remains committed to its broader research and development strategy, including its ongoing anti-obesity pre-clinical program. The team also continues to explore additional pipeline opportunities in gastrointestinal health.
Dr David Brookes, Executive Chair of Anatara, acknowledged the mixed results but highlighted the value of the trial's secondary findings. He emphasized that these data points, particularly the statistically significant improvements in patient-reported outcomes, could offer meaningful insights for both clinical development and commercial interest going forward.
Anatara’s latest update reflects a balanced outlook—acknowledging the challenge of not meeting a primary endpoint while recognizing valuable findings that support further development and exploration in gastrointestinal therapeutics.
