UPDATE -- Galectin Therapeutics Announces Commencement of Patient Enrollment of the Adaptively-Designed Phase 2b/3 Trial of Belapectin in NASH Cirrhosis

Clinical trial for patients with NASH cirrhosis who have the highest need for effective therapy

Belapectin has previously shown ability to prevent the development of esophageal varices in this patient population

Compelling NASH-RX trial result could potentially lead to accelerated FDA approval and/or partnership opportunities and fulfill an acute unmet medical need

NORCROSS, Ga., June 30, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, announced today that it has enrolled its first patients in the NASH-RX trial. NASH-RX is an international, seamless, adaptively-designed Phase 2b/3 trial of its galectin-3 inhibitor belapectin (GR-MD-02), the company's lead compound, in nonalcoholic steatohepatitis (NASH) cirrhosis patients who have clinical signs of portal hypertension and are at risk of developing esophageal varices. Belapectin had previously been shown that it could prevent the development of new varices in this patient population in the Phase 2 NASH-CX clinical trial (Gastroenterology 2020;158:1334–1345 or https://doi.org/10.1053/j.gastro.2019.11.296).

NASH-RX is expected to enroll approximately 315 NASH patients in the Phase 2b part of the trial at approximately 130 sites in 12 countries in North America, Europe, Asia and Australia. During the Phase 2b part of the trial, two belapectin doses, 2 mg/kg of lean body mass (LBM) and 4 mg/kg LBM, will be compared to placebo. Prior trials have demonstrated the good tolerance profile and apparent safety of belapectin with doses of up to 8 mg/kg LBM, notably for up to 52 weeks of treatment in patients with NASH cirrhosis (Phase 2b NASH-CX Study).

The study design provides for a prespecified interim analysis (IA) of efficacy and safety data conducted after all planned subjects in the Phase 2b component have completed at least 78 weeks (18 months) of treatment and a gastro-esophageal endoscopic assessment. This adaptive design allows for patients to seamlessly transition from the Phase 2b component into the Phase 3 stage, as well as helps determine the optimal dose, bolsters the efficacy signal, and re-evaluates the sample size and statistical power for the Phase 3 stage of the trial. These adaptations are designed to increase the statistical power for detecting a successful outcome. The IA also provides for adjustment in the randomization ratio, refinement of inclusion/exclusion criteria and the potential termination of the study for overwhelming efficacy or for futility.