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

“The unmet medical need for an effective treatment for patients with NASH cirrhosis remains a compelling motivation to vigorously pursue our therapy,” commented Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics. “Moreover, if the results of the NASH-RX trial are compelling, there could be the potential for accelerated FDA approval and/or partnership opportunities.”

Unlike most other clinical trials focused primarily on earlier stages of NASH, the NASH-RX study population will comprise patients with compensated liver cirrhosis. Based on the results of the NASH-CX trial, NASH-RX is focused on patients who have not yet developed esophageal varices but are at increased risk of developing these potentially life-threatening complications. Consequently, patient selection for both Phase 2b and Phase 3 will be based on clinical signs of portal hypertension such as a depressed platelet count (thrombocytopenia), an enlargement of the spleen (splenomegaly) and/or evidence of collateral vessels.

The primary endpoint of the trial is to assess the effect of belapectin on the incidence of new varices. A centralized review system of video recording of esophagogastroduodenoscopy (EGD) has been put in place, and the primary endpoint will be adjudicated by expert EGD readers. Key secondary endpoints will assess the type of varices (sizes and/or bleeding) and other clinical events, such as ascites, hepatic encephalopathy, listing for liver transplantation or death.

NASH-RX was designed in accordance with advice from the U.S. Food and Drug Administration (FDA) and with key contributions from our NASH-RX co-primary study investigators, Dr. Naga Chalasani and Dr. Stephen Harrison, both widely recognized expert hepatologists for NASH, biostatistical experts and numerous other collaborators at Covance, the CRO for the study. The design of the NASH-RX trial optimizes patient enrollment and retention and minimizes the need for invasive tests.

Pol Boudes, M.D., Chief Medical Officer for Galectin commented, “Once liver fibrosis has progressed to cirrhosis, NASH patients can no longer expect significant improvements from changes in their lifestyle. These patients are in dire need of new options, and this trial may prove pivotal in improving their condition. The study’s seamless and adaptive design is very innovative, and the primary endpoint minimizes the inconvenience for patients while being relevant to real life medical practice. We are extremely excited to start the study and give thanks in advance to all the patients who will participate and the medical teams that will support them.”