Lyra Therapeutics Inc. (NASDAQ: LYRA) stock fell by 6.9% at last close whereas the LYRA stock-price gains by 8.37% in the pre-market trading session. Lyra Pharmaceuticals is a clinical-stage therapeutics business that uses its unique XTreo platform to deliver medicines to sick tissues that are difficult to reach using traditional treatment methods.
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What happened?
LYRA’s pharmacokinetic (PK) trial of LYR-210 yielded encouraging topline findings, according to Lyra Therapeutics. The study’s findings confirm LYR-210’s safety profile and offer a PK bridge to the known safety of mometasone furoate (MF) for submission of a 505(b)(2) New Drug Application (NDA).
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The PK and safety of LYR-210 in adult patients with chronic rhinosinusitis were investigated in a 56-day open label, multi-center, and US research (CRS). The study’s main goal was to figure out what LYR-210’s PK profile was like. LYR-210 2500 g and LYR-210 7500 g were given to half of the participants in the trial. The study found that both dosages were safe and well tolerated, with the 7500 ug dose’s mean maximum plasma concentration (Cmax) falling substantially below the Cmax set for MF formulations approved by the US Food and Drug Administration. LYR-210’s capacity to give constant and steady dosage over the whole treatment period is supported by MF blood plasma levels recorded during the PK trial. This was the first LYR-210 research in the United States, and it was completed in 11 weeks across four sites.
At the forthcoming American Rhinologic Society Annual Meeting in October 2021, Lyra will share findings from their PK study of LYR-210 in a podium presentation.
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Maria Palasis, President and CEO of Lyra Therapeutics stated,
LYR-210 can elute mometasone furoate safely, consistently for 6 months, and locally to the inflamed mucosal tissue of CRS patients, according to the results of their PK research. These findings will support a 505(b)(2) approach for the NDA filing of LYR-210. They are ecstatic with the speed with which their first patients in the United States have enrolled, and they feel this speaks well for interest in their Phase 3 study, which they plan to launch towards the end of the year.
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