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FDA grants fast track designation to EC-18 for chemoradiation-induced oral mucositis
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The FDA granted fast track designation to mosedipimod for management of chemoradiation-induced oral mucositis, according to the agent’s manufacturer.
Mosedipimod (EC-18, Enzychem Lifesciences) — a synthetic palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol — is a candidate compound for a new drug with immunomodulation function, according to an Enzychem Lifesciences-issued press release.
The company completed phase 1 trials in the United States and South Korea.
Phase 2 trials are underway to investigate the efficacy and safety of the agent for chemoradiation-induced oral mucositis and chemotherapy-induced neutropenia.
“Along with the orphan drug designation granted to EC-18 for acute radiation syndrome last December, this fast track designation on chemoradiation-induced oral mucositis will expedite the process of clinical trials and global licensing deals,” Ki Young Sohn, chairman and CEO of Enzychem Lifesciences, said in the release.