Galera Therapeutics, Inc. announced that it has received official meeting minutes from the Type A meeting with the United States Food and Drug Administration (FDA) held September 28, 2023 in which the FDA reiterated the need for an additional Phase 3 trial of avasopasem manganese (avasopasem) for radiotherapy-induced SOM. The company also decided to halt the Phase 2b GRECO-2 trial of rucosopasem manganese (rucosopasem) in patients with locally advanced pancreatic cancer (LAPC) and the Phase 1/2 GRECO-1 trial of rucosopasem in patients with non-small cell lung cancer (NCSLC), following a futility analysis of the GRECO-2 trial. The Company believes this decision will enable the Company to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value.

In the Type A Meeting minutes, the FDA reiterated that results from an additional Phase 3 trial will be required to support resubmission of the Company's New Drug Application (NDA) for avasopasem in radiotherapy-induced SOM. The company is disappointed that the FDA did not find the data from 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 (deaths). 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 current resources and the results of the futility analysis, the company has made the difficult decision to discontinue both GRECO trials. The company will analyze the data collected to date to determine next steps for the asset, and thank the patients and providers who participated in both trials.