Galera Therapeutics has received a Complete Response Letter (CRL) from the FDA regarding its application for avasopasem for the treatment of severe oral mucositis in patients with locally advanced head and neck cancer.
In a press release shared this week, the biotech outlined that the FDA's concern stems from the ROMAN trial outcomes and supporting data from the GT-201 trial, indicating insufficient proof of avasopasem's effectiveness and safety in reducing oral mucositis in head and neck cancer patients undergoing treatment. Oral mucositis is a side effect of radiation therapy characterized by severe pain, inflammation, ulceration and bleeding of the mouth.
The avasopasem NDA encompassed data from 678 patients from the phase 3 ROMAN and phase 2b GT-201 trials. Avasopasem had previously received Fast Track and Breakthrough Therapy designations from the FDA due to its potential to significantly improve radiotherapy-induced oral mucositis. The NDA had been granted Priority Review, a designation reserved for treatments offering substantial advantages over existing options for treating serious conditions.
The rejection didn't necessarily come as a surprise. Back in 2021, Galera announced that the ROMAN trial had failed to meet its primary endpoint.
Now, in response to the CRL, Galera says it intends to request a Type A meeting with the FDA to gain insights into the decision and explore avenues for resubmitting avasopasem for approval. The company is also considering potential partnerships for avasopasem and its second candidate, rucosopasem.
Following the setback, Galera is taking proactive steps to preserve capital, including a 70% reduction in its workforce. The company will allocate resources toward avasopasem and ongoing trials for rucosopasem, which aims to enhance outcomes for lung and pancreatic cancer patients undergoing stereotactic body radiation therapy.