- Lyra Therapeutics (NASDAQ:LYRA) perks up 8.3% premarket after announcing positive topline results from the pharmacokinetic (PK) study of LYR-210 in adults with chronic rhinosinusitis (CRS), an inflammatory disease of the paranasal sinuses.
- The study enrolled 24 patients, half of whom received LYR-210 2500 µg and the other half received 7500 µg dose.
- The study indicated that both doses were safe and well tolerated, with the mean maximum plasma concentration (Cmax) observed with the 7500 ug dose well below Cmax established for FDA-approved formulations of mometasone furoate (MF).
- Data obtained from the study are supportive of LYR-210’s safety profile and provide a PK bridge to the established safety of MF for a 505(b)(2) pathway for NDA submission.
- MF blood plasma levels observed support LYR-210’s ability to deliver consistent and steady dosing over the entire treatment period of 6 months.