Liquidia Technologies has announced that the Phase 3 INSPIRE study of its LIQ861 DPI in pulmonary arterial hypertension (“PAH”) patients met its primary endpoint. In January 2019, the company announced encouraging preliminary results from the study.
According to Liquidia, the 2-month study, which enrolled 109 patients, demonstrated that doses of up to 150 mcg of LIQ861 were well tolerated, with only mild-to-moderate treatment-related adverse events, most commonly cough. The company also said that a crossover study comparing BE and PK in patients switching from Tyvaso treprostinil inhalation solution to LIQ861 was fully enrolled, with results expected in the second quarter of 2019.
Liquidia CEO Neal Fowler said, “We are extremely grateful to the patients participating in the clinical trial and for the effort and speed with which our investigators completed enrollment. We believe the commitment to this study signals an increasing need for safe, more convenient inhaled treatment options. We are preparing the new drug application submission, while collecting additional longitudinal data on the benefits from LIQ861.”
Read the Liquidia Technologies press release.
