Galera Submitted New Drug Application for Avasopasem for Severe Oral Mucositis

On December 12, 2022, Galera Therapeutics, Inc. announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avasopasem manganese 90 mg for radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care treatment.

SOM is defined by extremely painful mouth sores and the inability to eat solid food or drink liquids. Medicines including prescription opioids may temporarily reduce the pain. Feeding tubes to maintain nutrition and hydration may be needed. SOM can cause interruptions in cancer treatment. There are currently no FDA-approved drugs for patients with HNC at risk of, or experiencing, SOM.

The NDA is based on two positive randomized, double-blinded, placebo-controlled trials. Results from the 455-patient ROMAN trial demonstrated a clinically meaningful reduction in patients’ SOM burden across multiple endpoints including incidence, severity, and the number of days patients experience SOM, as well as time to SOM onset. Avasopasem manganese was generally well tolerated compared to placebo. Adverse events were consistent with those expected for patients receiving standard-of-care chemoradiation therapy.

“With submission of this NDA, we achieved an important milestone towards our goal of transforming radiotherapy, potentially bringing patients with head and neck cancer the first approved drug for SOM and relief from its tremendous burden,” said Mel Sorensen, M.D., President and Chief Executive Officer of Galera Therapeutics.

Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company headquartered in Malvern, PA. For more information, please visit www.galeratx.com.