Galera Therapeutics says FDA confirms need for new trial for avasopasem for SOM

Galera Therapeutics has received official meeting minutes from the Type A meeting with the United States Food and Drug Administration held September 28, 2023 in which the FDA reiterated the need for an additional Phase 3 trial of avasopasem manganese for radiotherapy-induced SOM. The Company also decided to halt the Phase 2b GRECO-2 trial of rucosopasem manganese in patients with locally advanced pancreatic cancer and the Phase 1/2 GRECO-1 trial of rucosopasem in patients with non-small cell lung cancer, 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 for avasopasem in radiotherapy-induced SOM.