Galecto, Inc. announced that it has resumed recruitment in its Phase 2b GALACTIC-1 trial of GB0139 for the treatment of Idiopathic Pulmonary Fibrosis under a revised protocol that was submitted to the U.S. Food and Drug Administration and other regulatory bodies, including those in Australia, Germany, Spain and the United Kingdom. Following the recommendation from an independent Data Safety Monitoring Board in March 2021 to modify the GALACTIC-1 trial protocol, 38 patients continued treatment in this Phase 2b trial. Under the revised protocol, the company is now recruiting additional patients who are not taking nintedanib or pirfenidone at screening, who will be randomized 2:1 to receive either GB0139 3 mg or placebo. GALACTIC-1 is a 52-week randomized, double-blind, multicenter, parallel, placebo-controlled Phase 2b trial being conducted across more than 100 centers globally, investigating the safety and efficacy of company’s lead inhaled compound, GB0139, in up to 210 patients with IPF. The revised trial design retains the same statistical powering to assess the primary endpoint of forced vital capacity decline over 52 weeks. The company anticipates that topline data from the GALACTIC-1 trial will be available by mid-2023.