FDA fast-tracks Galera's oral mucositis therapy

The U.S. Food and Drug Administration (FDA) has granted fast-track status to Galera Therapeutics for a drug that may reduce the severity and incidence of radiation- and chemotherapy-induced oral mucositis.

Galera is conducting a phase IIb trial of the drug, known as GC4419, to evaluate its safety and efficacy in head and neck cancer (HNC) patients. The company will investigate both 30- and 90-mg doses of GC4419 in the double-blind, randomized clinical trial.

"These are important milestones for Galera as the fast track designation validates the immediate need for treatments for [oral mucositis], and the potential of GC4419 to address this unmet need," stated J. Mel Sorensen, MD, CEO of Galera, in a press release. "Coupled with our recent initiated phase IIb trial of GC4419, fast-track offers the possibility to accelerate bringing this critical advance to HNC patients."