Galectin Therapeutics aligns with FDA on belapectin Phase 3 design
Galectin Therapeutics has secured FDA alignment on the core design elements of a planned Phase 3 trial for belapectin, its galectin-3 inhibitor, in patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension. The Norcross, Georgia-based company said the in-person Type C meeting produced agreement on the primary endpoint, study methodology, and the regulatory framework required for a full approval application.
The NASDAQ-listed company intends to submit the Phase 3 protocol to the FDA in the third quarter of 2026. In parallel, it is actively seeking strategic and financial partners to fund development and eventual commercialisation of the asset.
Trial design and endpoint
The planned trial will be a randomised, double-blind, placebo-controlled study assessing belapectin's ability to prevent disease progression. The agreed primary endpoint is a composite liver outcome that includes prevention of the development of large esophageal varices, defined as greater than 5 mm, which the company describes as a clinically meaningful marker of worsening portal hypertension in compensated MASH cirrhosis. The FDA also accepted Galectin's proposed blinded central endoscopy review process, a methodology the company says it developed and implemented during its earlier global Phase 2b/3 NAVIGATE trial.
Galectin plans to evaluate a single 2 mg dose of belapectin in the Phase 3 study, based on efficacy signals observed at that dose level in prior clinical work. The company expects trial size to be broadly comparable to NAVIGATE, though precise patient numbers were not disclosed. Chief Medical Officer Khurram Jamil said FDA's acceptance of the centralised endoscopy review process "underscores the scientific rigor and operational robustness of the methodology that Galectin pioneered."
Regulatory path and market context
The FDA confirmed that the MASH cirrhosis population requires a traditional approval pathway rather than the accelerated route, based on histological endpoints, that may be available in earlier-stage MASH. Galectin said recent FDA communications regarding the acceptability of a single, adequate and well-controlled confirmatory trial for marketing approval support the view that one Phase 3 study could be sufficient for a broad indication focused on preventing cirrhosis progression.
The MASH field has grown substantially as a drug development priority over the past several years, driven by rising prevalence of metabolic liver disease globally and the approval of resmetirom (Rezdiffra) by the FDA in March 2024 for non-cirrhotic MASH with moderate-to-advanced fibrosis. Resmetirom's label does not extend to patients with cirrhosis, which represents the highest-risk population and the specific segment Galectin is targeting. Chief Executive Joel Lewis noted that this patient group is currently excluded from other ongoing drug development programmes, a point the FDA acknowledged during the meeting.
Several other companies, including Madrigal Pharmaceuticals and a number of mid-to-late-stage developers, are active in adjacent MASH fibrosis stages, but the cirrhotic population with portal hypertension remains comparatively under-served in terms of approved or near-approval therapies. Whether belapectin can generate a Phase 3 readout sufficient to compete in a field that is attracting substantial commercial interest from larger pharmaceutical partners will depend on Galectin's ability to close a financing or partnership deal ahead of trial initiation. The company has carried operating losses since inception, a factor that gives its ongoing partnership search particular urgency.
Investors will focus on the Q3 2026 protocol submission as the immediate near-term catalyst, followed by news of any strategic partnership or funding arrangement that provides the capital runway needed to execute a trial of NAVIGATE-comparable scale.