GaRP-IBS Phase II Trial: 40% Symptom Reduction but Primary Endpoint Eludes Anatara

GaRP-IBS Trial Results: A Mixed Outcome

Anatara Lifesciences Ltd (ASX: ANR) has provided a detailed update on its Q3 FY25 activities, highlighting the completion of Stage 2 of its Phase II GaRP-IBS (Irritable Bowel Syndrome) trial. While the trial did not meet its primary efficacy endpoint of statistically significant reduction in IBS Symptom Severity Score (IBS-SSS) compared to placebo, several secondary endpoints delivered encouraging signals.

The headline analysis, announced post-quarter on 17 April 2025, confirmed no safety concerns, an important reassurance for the product’s clinical profile. Notably, the trial demonstrated a statistically significant improvement in anxiety scores (P=0.034 at Week 8) and a highly significant result in the IBS-Adequate Relief endpoint (P=0.004 at 10 weeks), indicating that participants self-assessed as responders more frequently than non-responders compared to placebo.

Despite the primary endpoint not being met, the trial cohort experienced a consistent and sustained reduction in IBS-SSS by more than 40%, although this did not reach statistical significance against placebo. The secondary endpoint of achieving a 20% or greater reduction in IBS-SSS from baseline was clearly met, suggesting meaningful symptomatic improvement for patients receiving the GaRP product.

Advancing the Anti-Obesity Pipeline

Parallel to the IBS trial, Anatara has initiated pre-clinical in-vivo studies for its Anti-Obesity Project, following ethics approval and collaboration agreements with the University of Newcastle. These proof-of-concept studies aim to evaluate several candidate compounds targeting endogenous GLP-1 stimulation, a mechanism relevant to weight loss maintenance and rebound prevention after cessation of existing therapies.

The company has allocated over $250,000 to these studies, which are expected to run for 6 to 9 months. This project represents a strategic diversification of Anatara’s pipeline beyond gastrointestinal conditions, potentially opening new commercial avenues if successful.

Financial Position and Corporate Changes

Financially, Anatara reported a cash balance of $0.393 million at quarter-end, down from $1.052 million at the end of December 2024. Net cash outflows from operating and financing activities totaled $0.66 million during the quarter. The company continues to benefit from an accumulating R&D tax incentive rebate of approximately $500,000 as of H1 FY25, which provides some buffer to its cash runway.

On the corporate front, the company announced the resignation of Non-Executive Director Nicholas Haslam and the appointment of Jonathan Lindh, who will also continue as Company Secretary. Operationally, Anatara is streamlining its workforce and reducing contracted services in response to the mixed trial results, with key executives transitioning to reduced roles or non-executive positions.

Strategic Outlook Amidst Mixed Trial Results

Following the GaRP-IBS trial outcome, Anatara is reassessing its strategic direction. The company remains committed to summarizing and understanding the commercial potential of the GaRP product in gastrointestinal health, including exploring broader indications such as the gut-brain axis. However, manufacturing and ingredient procurement are currently deprioritized.

The mixed clinical data presents both challenges and opportunities. While the primary endpoint was not achieved, the significant secondary benefits in anxiety and patient-reported relief could support niche positioning or combination therapies. The ongoing anti-obesity pre-clinical program also signals Anatara’s intent to expand its product portfolio into high-demand therapeutic areas.