Liquidia Announces Clinical Update on INSPIRE; Targeting NDA Filing for LIQ861 in Late 2019
Liquidia Corporation (LQDA)
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Source: GlobeNewswire
RESEARCH TRIANGLE PARK, N.C., June 05, 2019 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq: LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company, today provided an update on the Phase 3 INSPIRE trial and development of LIQ861 for the treatment of pulmonary arterial hypertension (PAH). As previously announced, the initial analysis of the INSPIRE study indicated the study has met its primary endpoint of safety and tolerability of LIQ861 at the two-month timepoint. Results from the INSPIRE study indicates that the 75 mcg capsule strength of LIQ861 (single capsule, 1-2 breaths) correlates with the 54 mcg dose of Tyvaso® (9 breaths), the maximum recommended label dose of Tyvaso®. INSPIRE also included a one-directional, crossover sub-study to assess the comparable bioavailability and pharmacokinetics (PK) of single doses of LIQ861 and Tyvaso in 18 PAH patients. The company targets NDA submission in late 2019 that will include additional data generated from ong
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