Liquidia Technologies, Inc. announced positive Phase 1 and preclinical results evaluating LIQ861 for the treatment of PAH at the 12th Pulmonary Vascular Research Institute (PVRI) Annual World Congress on Pulmonary Vascular Disease in Singapore. LIQ861, developed using Liquidia’s proprietary PRINT® technology, is a powder formulation of treprostinil designed for deep-lung delivery using a disposable, dry powder inhaler (DPI). The safety, tolerability and pharmacokinetics results from the studies presented at PVRI support advancing the program into the open-label Phase 3 trial (INSPIRE), which initiated earlier in January 2018. In the randomized, placebo-controlled, double-blinded Phase 1 clinical trial, 57 healthy volunteers were evaluated, following a single administration of LIQ861 at doses between 25 mcg and 150 mcg. LIQ861 was well-tolerated at all doses tested, with a proportional dose response in pharmacokinetics. No serious adverse events were observed for all LIQ861 doses up to 150 mcg. Notably, at both 100 mcg and 150 mcg doses of LIQ861, 50% of individuals had measurable treprostinil at four hours, which could minimize PAH symptoms between dosing cycles. PAH is a rare, chronic and progressive disease caused by the hardening and narrowing of the pulmonary arteries, which often results in heart failure. Previously approved by the U.S. Food and Drug Administration (FDA) in parenteral, nebulized and oral formulations, treprostinil is a synthetic analog of prostacyclin, a vasoactive mediator deficient in patients with PAH yet essential to normal lung function to regulate vessel tone. LIQ861 is being evaluated in INSPIRE (Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil), an open-label Phase 3 clinical trial, which expects to enroll at least 100 patients with PAH across multiple U.S. sites. Primary endpoints are long-term safety and tolerability of LIQ861. Topline data from INSPIRE are expected in 2019. Based on feedback from the FDA, Liquidia believes that INSPIRE will support the filing of an NDA for LIQ861.