Galera Announces Plan to Submit Avasopasem NDA by Year End
After discussions with FDA, Company is on track to file an NDA for avasopasem for the treatment of radiotherapy-induced severe oral mucositis by end of 2022
Malvern, PA. -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced its intent to file a New Drug Application (NDA) for avasopasem manganese (avasopasem) for the treatment of radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer with the U.S. Food and Drug Administration (FDA) by the end of 2022.
“We are excited to take this next step after our productive interactions with the FDA,” said Mel Sorensen, M.D., Galera’s President and CEO. “The NDA will be based on the positive and clinically meaningful data from our Phase 3 ROMAN trial and our randomized Phase 2b trial. There are no FDA-approved treatments for radiotherapy-induced SOM, which affects over 40,000 patients with head and neck cancer undergoing radiotherapy in the U.S. alone, and we are enthusiastically working to bring this potential treatment to patients as quickly as possible.”
The FDA has already granted Breakthrough Therapy and Fast Track Designations to avasopasem for the reduction of SOM induced by radiotherapy. The Company looks forward to continuing to work with the FDA to bring this potential new treatment to patients with head and neck cancer receiving radiotherapy.
The Company also recently announced that detailed results from the ROMAN trial will be presented in an oral presentation at the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on Friday, June 3, 2022.
About Severe Oral Mucositis (SOM)
Approximately 42,000 patients with head and neck cancer undergo standard-of-care radiotherapy every year in the U.S. and are at risk of experiencing SOM. In patients with head and neck cancer, radiotherapy is a mainstay of treatment. Approximately 70 percent of patients receiving radiotherapy for head and neck cancer develop SOM, defined by the inability to eat solid food or drink liquids. The impact on patients who develop SOM is substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration are required. SOM can adversely affect cancer treatment outcomes by causing interruptions in radiotherapy, which may compromise the otherwise good prognosis for tumor control in many of these patients. There is currently no drug approved to prevent or treat SOM for these patients.
Avasopasem manganese (avasopasem, or GC4419) is a selective small molecule dismutase mimetic in development for the reduction of radiation-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiation-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.
About Galera Therapeutics
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese (GC4419, also referred to as avasopasem) is being evaluated for radiotherapy-induced toxicities. The Company’s second product candidate, rucosopasem manganese (GC4711, also referred to as rucosopasem), is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA.