FDA Issues Complete Response for Avasopasem for Severe Oral Mucositis

FDA has issued a complete response letter for Galera Therapeutics’ avasopasem manganese. The new drug application was seeking approval to treat radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer. The agency indicated that clinical trial and supporting data did not provide evidence of avasopasem’s effectiveness and safety and requested an additional trial for resubmission.

“This response from the FDA is deeply disappointing for Galera and for patients who suffer from severe oral mucositis,” Mel Sorensen, M.D., Galera’s president and CEO, said in a press release. “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.”

Oral mucositis results in tissue swelling and irritation in the mouth and can be a result of chemotherapy and radiotherapy. About 42,000 patients with head and neck cancer undergo radiotherapy every year in the United States and about 70% of patients will develop severe oral mucositis during treatment. This often results in patients being hospitalization and needing feeding tubes.

In an investor call, Sorensen said Galera had conducted trials with 700 patients, including two randomized trials. Both of these met primary endpoints. He said the company plans to meet with the FDA to discuss next steps. He said the timing, size and details of a new trial would need to be discussed with the regulatory agency.

The NDA submission for avasopasem included data from 678 patients enrolled in two trials (the phase 3 ROMAN and the phase 2b GT-201). Both trials demonstrated that avasopasem reduced measures of patients’ oral mucositis, including the number days patients experience oral mucositis, reducing the severity, and delaying the onset of oral mucositis. Additionally, in the ROMAN trial, avasopasem reduced cisplatin-induced chronic kidney disease by half at one year. These data were presented at the 2023 American Society of Clinical Oncology meeting. 

Side effects from avasopasem included increases in rates of hypotension and mild nausea.

Galera has also announced that it is reducing its workforce by 70% as it works to find a path for avasopasem and to focus on the development of rucosopasem, a therapy in development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) for patients with non-small cell lung cancer and locally advanced pancreatic cancer. Stereotactic body radiation therapy is a type of high-fraction dose radiotherapy.

A phase 2b trial in currently under way with rucosopasem with 220 patients, and topline data is expected by the end of 2024. The FDA has granted orphan drug designation to rucosopasem in patients with pancreatic cancer.