RESEARCH TRIANGLE PARK — Liquidia Technologies, Inc., a late-stage clinical biopharmaceutical company based in Morrisville, has announced the final submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for LIQ861, an investigational, inhaled dry powder treatment for patients with pulmonary arterial hypertension (PAH).
The submission comes after three clinical studies to establish the “safety, tolerability and pharmacokinetic profile” of LIQ861.
The open-label Phase 3 study, known as INSPIRE (Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil) (NCT03399604), included 121 PAH patients who transitioned from stable doses of the reference listed drug or added LIQ861 to no more than two approved non-prostacyclin oral PAH therapies. The company also completed pharmacokinetic studies to establish the bioavailability of LIQ861 relative to the bioavailability of the reference listed drug.
“The submission of the NDA for LIQ861 in the U.S. is a significant milestone for our company and our goal to address an important unmet need in the delivery of inhaled therapy for PAH patients,” said Neal Fowler, Liquidia’s CEO, in a statement. “We would like to sincerely thank the patients, their families and the clinical investigators for their participation in the LIQ861 clinical program, and we look forward to working closely with the FDA during the review process.”