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Wednesday, April 3, 2019

Liquidia Presents Phase 3 Trial Data for LIQ861 at ISHLT 39th Annual Meeting

Liquidia Technologies, Inc. (Nasdaq: LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of LIQ861, announced today additional detailed safety and exploratory endpoint findings at the two-month timepoint for the Phase 3 INSPIRE trial. Nicholas Hill, MD, Chief Pulmonary, Critical Care & Sleep Division and Professor of Medicine at Tufts University School of Medicine and INSPIRE Principal Investigator, presented the data at the opening plenary session of the 39th International Society for Heart & Lung Transplantation (ISHLT) Meeting and Scientific Sessions in Orlando, Florida. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil that is produced using its PRINT® Technology, as an alternative to current inhaled treprostinil therapy for the treatment of patients with pulmonary arterial hypertension (PAH) (WHO Group 1).
“The two-month results of the INSPIRE trial are promising for patients with PAH. Inhaled therapy offers the benefit of getting drug directly to the lungs and we are encouraged that the safety, tolerability and quality of life metrics suggest that LIQ861 is an attractive and more convenient therapy versus the currently available inhaled therapies,” said Dr. Hill.
In March 2019, Liquidia reported two-month top-line results of the Phase 3 INSPIRE study, which indicated that the study had met its primary endpoint of safety and tolerability of LIQ861 in (PAH) patients. The ISHLT presentation, “INSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in PAH,” provides detailed results on the treatment emergent adverse event (TEAE) profile, duration of treatment by  group (including those adding LIQ861 to non-prostacyclin oral therapy and those transitioning from Tyvaso®*) along with the performance of LIQ861 against exploratory endpoints such as patient quality of life metrics.
“We are continuing to demonstrate the potential benefits of LIQ861 as we present additional data from the INSPIRE trial,” said Neal Fowler, Chief Executive Officer of Liquidia. “LIQ861 is a convenient inhaled therapy that effectively manages PAH with excellent safety and tolerability. It’s our belief that LIQ861 can help PAH patients more easily manage their disease, and more importantly, the quality of their lives.”

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