GaRP-IBS Trial Misses Primary Endpoint: What This Means for Anatara’s Future

GaRP-IBS Phase II Trial – Safety Confirmed, Efficacy Mixed

Anatara Lifesciences has released its Q4 FY25 activities report, highlighting the completion of Stage 2 of its Phase II GaRP-IBS trial. The headline analysis confirmed no safety concerns, a critical milestone for any clinical development. However, the primary efficacy endpoint; measured by reduction in the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) compared to placebo; was not met despite a consistent and sustained 40% symptom improvement in the treatment arm.

Secondary endpoints painted a more encouraging picture. The trial cohort on the GaRP product achieved a clear 20% or more reduction in IBS-SSS compared to baseline. Notably, anxiety scores improved significantly (P=0.034 at Week 8), while depression scores remained stable within normal ranges. Additionally, patient self-assessment of adequate relief was highly significant at 10 weeks (P=0.004), indicating meaningful symptomatic benefit beyond placebo.

Post Hoc Analyses Reveal Symptom-Specific Relief

Following an internal audit, post hoc analyses dissected the IBS-SSS into its five constituent questions. These revealed statistically significant improvements in pain severity, pain frequency, and abdominal distension; key drivers of patient discomfort. Conversely, more subjective measures related to bowel satisfaction and lifestyle interference did not show clear improvement, which diluted the overall primary endpoint result. This nuanced data suggests the GaRP product may target specific symptom domains more effectively, a factor that could inform future trial designs and commercial positioning.

Expanding Intellectual Property Footprint

On the intellectual property front, Anatara secured important patent grants for its GaRP product, titled “Gastrointestinal Health Composition,” in Hong Kong and Japan during the quarter. These follow earlier grants in the European Union and Australia, collectively strengthening the company’s global IP protection. The patents, valid for 20 years from October 2020, underpin Anatara’s commercialisation strategy and provide a competitive moat for its gastrointestinal health portfolio.

Progress in Anti-Obesity Pre-Clinical Studies

Beyond GaRP, the company advanced its Anti-Obesity Project, moving into the treatment challenge phase with diet-induced obese mice at the University of Newcastle. This project aims to develop an oral complementary medication to support weight loss maintenance and prevent rebound weight gain, leveraging stimulation of endogenous GLP-1. Initial studies are expected to run for approximately six months, with further cohorts possible depending on outcomes.

Financial and Operational Updates

Financially, Anatara reported a net cash outflow of $0.343 million for the quarter, ending with a modest cash balance of $0.051 million. However, the company’s liquidity was significantly improved post-quarter with the receipt of a $0.969 million Australian Government R&D tax incentive refund. Operationally, Anatara has streamlined its workforce, transitioning key executives to reduced roles and de-prioritising manufacturing and ingredient procurement as it refocuses on commercialisation and strategic opportunities.