US-based biopharmaceutical company Liquidia Technologies has started a Phase lll clinical trial to evaluate LIQ861 for the treatment of pulmonary arterial hypertension (PAH).
Developed using the company’s PRINT technology, LIQ861 is a powder formulation of treprostinil designed for deep-lung delivery using a disposable, dry powder inhaler (DPI).
The open-label clinical trial is expected to enrol around 100 patients with PAH across various sites in the US.
First patients for the trial are set to be enrolled within the next few weeks.
Primary objectives of the trial are long-term safety and tolerability of LIQ861, while topline data is expected to be achieved by 2019.
Liquidia Technologies CEO Neal Fowler said: “LIQ861 shows the potential of our PRINT technology to optimise safety, efficacy, and convenience of therapeutics.
“The initiation of our trial marks an important milestone for Liquidia, for those living with PAH and for the PAH community at large.”
With the latest Phase lll trial, Liquidia expects to receive regulatory approval for LIQ861 from the US Food and Drug Administration (FDA).
In March last year, the company concluded a Phase l clinical trial of LIQ861 in healthy volunteers. During the trial, the drug was found to be well-tolerated at all doses, with a proportional response in pharmacokinetics.
Liquidia plans to provide additional data from the Phase l trial this year.