71 Patients Enrolled in Anatara’s GaRP-IBS Trial as Capital Raise Boosts Cash

Clinical Trial Progress and Recruitment Update

Anatara Lifesciences Ltd (ASX: ANR) has announced a significant milestone in its pivotal Phase II GaRP-IBS clinical trial, pausing recruitment after enrolling 71 Intent-To-Treat participants in the second stage. This follows the successful completion of Stage 1, which demonstrated a greater than 50% reduction in IBS symptoms among 61 patients and confirmed a strong safety profile.

The trial is a randomised, double-blind, placebo-controlled study designed to rigorously evaluate the efficacy of Anatara's GaRP product, which targets the restoration and maintenance of the gastrointestinal tract lining and microbiome homeostasis. The company expects to deliver headline results in the first quarter of calendar year 2025, with final patient numbers and data analysis currently being finalised.

Commercial Potential and Market Context

GaRP’s development comes at a time of growing global focus on digestive health, with the digestive health market projected to reach US$23.4 billion by 2030, growing at a compound annual growth rate of 8.1%. Anatara’s product, protected by patents and composed of Generally Regarded As Safe (GRAS) components, aims to fill a significant unmet need in the treatment of Irritable Bowel Syndrome (IBS) and potentially other gastrointestinal disorders.

Positive trial outcomes could validate GaRP’s unique mechanism of action and open doors for commercial partnerships, as the company is already engaged in discussions with potential global partners interested in expanding their gastrointestinal health portfolios.

New Anti-Obesity Project and Pipeline Expansion

In addition to its IBS program, Anatara has commenced an anti-obesity project, allocating approximately $250,000 towards proof-of-concept in-vivo studies. These pre-clinical experiments are in the final stages of preparation for ethics submission and are expected to take around six months to complete once approved. This initiative reflects the company’s strategy to diversify its pipeline within human health, targeting conditions with significant unmet medical needs.

Financial Position and Corporate Developments

Financially, Anatara strengthened its balance sheet during the quarter, raising $0.75 million through a placement at $0.05 per share in November 2024, followed by an additional $0.274 million via a Share Purchase Plan on the same terms. These funds ensure the company is fully capitalised to complete the pivotal trial and advance the anti-obesity project.

Cash at quarter-end stood at $1.05 million, providing approximately 1.26 quarters of funding based on current operating cash flows. The company confirmed no immediate plans for further capital raising but remains confident in its ability to secure funds as needed, supported by ongoing R&D tax incentives and corporate activities.

Corporate governance updates included the retirement of Company Secretary Stephen Denaro and the appointment of Jonathan Lindh, an experienced lawyer and company secretary, signaling continuity in administrative leadership. The company also held its Annual General Meeting in November 2024 and hosted a well-attended investor webinar in December.

Looking Ahead

As Anatara approaches the critical readout of its GaRP-IBS trial results, the market will be watching closely for confirmation of the promising interim data. Success could not only validate the product’s therapeutic claims but also catalyse commercial partnerships and broaden the scope of indications for GaRP. Meanwhile, the anti-obesity project adds a new dimension to Anatara’s growth prospects, potentially positioning the company in another high-demand therapeutic area.