5 January 2018 - - Research Triangle Park, North Carolina-based late-stage clinical biopharmaceutical company Liquidia Technologies, Inc. has initiated a Phase 3 clinical trial evaluating LIQ861 for the treatment of pulmonary arterial hypertension (PAH), the company said.
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.
Previously approved by the US Food and Drug Administration in oral, nebulized and parenteral 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.
Liquidia expects to enroll at least 100 patients with PAH across multiple US sites in the open-label Phase 3 clinical trial, with the first patient enrolling within the next few weeks.
Primary endpoints of the trial are long-term safety and tolerability of LIQ861. Topline data are expected in 2019.
Liquidia Technologies is focused on improving the performance of medicines by precisely engineering drug particles. Its proprietary PRINT technology is designed to optimize the safety, efficacy, or route of administration of a wide range of therapies by engineering uniform drug particles in a virtually unlimited number of compositions, sizes, and shapes.
Currently, the company is developing two of its own product candidates using PRINT particles: LIQ861 for the treatment of PAH and LIQ865 for the treatment of post-operative pain. In addition, Liquidia collaborates with leading pharmaceutical companies to apply its PRINT technology across existing drugs, new chemical entities, and biologics.