Galecto Completes Dosing in 52-Week Phase 2b GALACTIC-1 Trial of GB0139 in Idiopathic Pulmonary Fibrosis

BOSTON, May 23, 2023 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and world leader in galectin biology focused on the development of novel treatments for fibrosis and cancer, today announced the last dosing of the last patient in the GALACTIC-1 Phase 2b trial of its most advanced product candidate, GB0139, for the treatment of idiopathic pulmonary fibrosis (IPF).

GALACTIC-1 is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial being conducted across approximately 100 centers globally. The study is designed to investigate the safety and efficacy of GB0139 in patients with IPF. 144 patients were randomized (2:1) to receive either a 3 mg dose of GB0139 or placebo once daily for 52 weeks. The primary endpoint of the trial is to assess the annual rate of decline in forced vital capacity (FVC) in adults who are not treated with or cannot tolerate nintedanib or pirfenidone. Reduction in the decline of FVC was accepted by the U.S. Food and Drug Administration as the primary endpoint in pivotal studies of the current standard-of-care treatments for IPF: nintedanib, marketed as Ofev by Boehringer Ingelheim, and pirfenidone, marketed as Esbriet by Roche/Genentech.

“We are pleased to have completed dosing in the GALACTIC-1 trial, which is a component in Galecto’s quest to develop anti-fibrotic drugs,” said Dr. Hans Schambye, President and Chief Executive Officer of Galecto. “GB0139 has been shown to specifically target galectin-3, one of the key regulators in IPF. Patients with IPF need new and more tolerable treatment options and we believe GB0139 has the potential to address this significant unmet medical need, while being easy to administer as a once-daily inhaled treatment. We’ve had significant interest in the outcome of the GALACTIC-1 trial and we plan to report topline data from this study in August 2023.”

IPF is a life-threatening, rapidly progressing, and irreversible disease, which causes scarring of the lungs and significant impairment of lung function. It affects approximately 100,000 people in the United States and is associated with significant morbidity and mortality, imposing substantial challenges for healthcare systems worldwide. The current standard-of-care treatment options for IPF have been shown to only have a modest impact on slowing the progression of the disease and have been associated with significant side effects, leading to poor therapeutic adherence or dose reduction.