- Lyra Therapeutics Inc (NASDAQ: LYRA) announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the FDA for LYR-210, its lead candidate for the treatment of chronic rhinosinusitis (CRS).
- Lyra and the FDA established key elements of the Phase 3 program.
- The single primary endpoint will evaluate improvement at week 24 using a composite score of three cardinal symptoms of CRS: nasal blockage, nasal discharge, and facial pain.
- Based on the Agency’s suggestion, Lyra will enroll approximately 350 subjects split into two replicate, largely concurrent Phase 3 clinical trials.
- Both studies will evaluate a 7500µg dose of LYR-210, and additional key clinical aspects of the studies will also be the same.
- The Phase 3 trial is expected to start by the end of 2021.
- Related content: Benzinga’s Full FDA Calendar.
- Price Action: LYRA shares are up 19.4% at $9.4 during the premarket session on the last check Wednesday.
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