Galera receives CRL from FDA for avasopasem manganese

Galera Therapeutics announced that it has received a Complete Response Letter, or CRL, from the FDA regarding the company’s New Drug Application, or NDA, for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together with the supporting data from the GT-201 trial are not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer. FDA stated that results from an additional clinical trial will be required for resubmission. The company intends to request a Type A meeting with the FDA to understand the FDA’s rationale for its decision and discuss next steps to support an NDA resubmission seeking approval of avasopasem. The company will also explore strategic alternatives, including partnering, for the continued development of avasopasem and rucosopasem. “This response from the FDA is deeply disappointing for Galera and for patients who suffer from severe oral mucositis,” said CEO Mel Sorensen. “We continue to believe in avasopasem’s potential to bring a meaningful benefit to these patients, who currently have no FDA-approved drugs for this debilitating condition. As we explore a potential approval path for avasopasem, we are taking decisive actions to extend our cash runway. Unfortunately, this necessitates reducing our workforce by approximately 70%.”