Liquidia Technologies has presented preclinical and Phase 1 study results for its LIQ861 inhaled treprostinil for the treatment of pulmonary arterial hypertension at the Annual World Congress of the Pulmonary Vascular Research Institute (PVRI), noting that the data supported advancement of LIQ861 into the INSPIRE Phase 3 trial which was initiated earlier this month.
The Phase 1 trial in 57 healthy subjects demonstrated dose proportionality at doses ranging from 25 μg to 150 μg, and LIQ861 was well tolerated at all doses, with no serious adverse events reported. Of the subjects who received 100 μg and 150 μg doses, trepostinil was measurable in 50% at 4 hours post dose.
Liquidia CEO Neal Fowler commented, “We are pleased to be presenting these exciting findings at PVRI and are encouraged by the data generated to-date, as we believe LIQ861 can help overcome some of the limitations of current nebulized therapies. LIQ861 has the potential to maximize the therapeutic benefits of treprostinil in treating PAH by safely and efficiently delivering higher doses of drug deeply into the lungs using a convenient, disposable DPI. These early findings support advancing directly into a Phase 3 clinical trial and bring us closer to being able to offer patients a potential game-changer for treating PAH.”
Senior VP of Product Development Robert Roscigno said, “Local delivery of prostacyclin analogs to the lungs is the ideal route of administration, as it minimizes the off-tissue adverse side effects of systemic delivery by delivering the drug where it is needed in the lungs. The clinical use of inhaled prostacyclin analogs is currently limited to nebulized therapies, which are inherently constrained by specific safety profiles, dosing convenience and efficacy. Prostacyclin analogs are central to PAH therapy and as such, there exists a strong need to develop products that can maximize their therapeutic benefits.”
Read the Liquidia Technologies press release.
