Galera Nabs FDA Fast Track for GC4419

The FDA has awarded Galera Therapeutics fast track designation for GC4419, a candidate that aims to reduce the severity and incidence of oral mucositis caused by radiation and chemotherapy.

Galera has begun enrollment in a Phase 2b study for head and neck cancer patients that will investigate the ability of 30- and 90-mg doses administered before radiation therapy. The study is expected to enroll 200 patients at roughly 55 sites in the U.S.