Frequency Therapeutics (NSDQ:FREQ) said today that it launched a Phase 2a study and won fast-track designation at the FDA for its regenerative hearing loss drug.
The fast-track program aims to speed up the approval of therapies for unmet needs in serious conditions. Woburn, Mass.-based Frequency’s FX-322 candidate is designed to stimulate the regrowth of sensory hair cells to treat chronic noise-induced hearing loss. The technology is based on activating progenitor cells – mature stem cells that can proliferate into different types of cells. The compound is injected into the middle ear in a slow-release gel.
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