Galera Therapeutics to discontinue both GRECO trials

“We are disappointed that the FDA did not find the data from our Phase 2b GT-201 and Phase 3 ROMAN trials sufficient for the approval of the NDA for avasopasem,” said Mel Sorensen, M.D., Galera’s President and CEO. “After discussing the data with the FDA, it is clear that their position is another Phase 3 trial is required.” To optimize the Company’s resources, it conducted a futility analysis of the GRECO-2 trial to assess the likelihood of a successful outcome. The analysis indicated that the trial was unlikely to succeed as designed. GRECO-2 is a randomized, double-blind, placebo-controlled Phase 2b trial evaluating rucosopasem or placebo in combination with SBRT in patients with LAPC. Overall survival is the trial’s primary endpoint. The trial was designed to enroll 220 patients with final analysis at 120 events The trial has enrolled 177 patients to date, and the futility analysis was conducted based on 35 deaths with a data cutoff of October 9, 2023. Dr. Sorensen continued, “In light of our current resources and the results of the futility analysis, we have made the difficult decision to discontinue both GRECO trials. We will analyze the data collected to date to determine next steps for the asset, and we thank the patients and providers who participated in both trials.”