Anatara Lifesciences (ASX:ANR) has updated investors on an analysis following the completion of Stage 2 of its GaRP-IBS (Irritable Bowel Syndrome) trial.
The company said the headline analysis was of the primary endpoints of safety, including treatment-related adverse events and the reduction in IBS-SSS (Severity Scoring System) compared to placebo. Secondary endpoints analysed included Adequate Relief (AR-IBS), Anxiety within the well-known HADS (Hospital Anxiety and Depression Scale ), and improvement in IBS-SSS compared to baseline.
Anatara said the Data Safety Monitoring Board confirmed its interpretation that the analysis revealed no concerning safety signals and that the product was well tolerated. However, the primary endpoint for efficacy of reducing IBS-SSS versus placebo was not met. The secondary endpoint of improvement in anxiety scores reached statistical significance.
Following the trial outcome, the company said it is considering future directions and opportunities, with further cash flow controls. It announced that John Michailidis will be in a non-executive director role only from the end of this week as part of a planned transition to retire the chief operating officer role. Simon Erskine will reduce his workload next month to 0.8 full-time equivalent as chief development officer.
Executive chair Dr David Brookes said, “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. The GaRP product appears to outperform placebo for IBS-SSS reduction but does not reach statistical significance, and the secondary endpoints suggest broader benefits consistent with the hypothesis on the mechanism of action. In particular, the statistically significant improvement in mild background anxiety points to support for the benefits to the gut-brain axis through assisting the homeostasis of the microbiome dynamics. Anatara will work efficiently towards summarising the pre-clinical studies and the IBS trial findings for commercial discussions. We will be endeavouring to maximise the value of the GaRP project while progressing the anti-obesity project concept, and there is already a focus on other opportunities and future directions.“
The company also provided an update on its GLP-1 agonism focused anti-obesity project. Proof-of-concept pre-clinical mice studies have commenced at the university involved, it said, with the project scope to be further determined by observations and milestones within 6 months.
