Safety and efficacy data from the phase 3 INSPIRE clinical trial of LIQ861 (Yutrepia™) in patients with pulmonary arterial hypertension (PAH) was presented at the American Thoracic Society (ATS) 2022 International Conference.
The study results were presented at both a minisymposium and a poster session during the conference and showed that LIQ861 provides a safe and tolerable treatment option for patients with PAH. No important adverse events (AEs) were reported during the study other than expected prostanoid-related AEs.
“LIQ861 dry powder formulation of treprostinil provides a safe and tolerable treatment for patients with PAH,” the authors said.
Continue Reading
During the trial, both prostanoid-naïve patients and those transferring from Tyvaso® were able to increase their doses during the trial. The mean initial dose of LIQ861 was 26.5 mcg for prostanoid-naïve patients and 68.4 mcg for transition patients. The median dose by the end of the study was 106 mcg 4 times daily with 1 patient achieving a dose of 212 mcg 4 times daily.
Read more about experimental therapies for PAH
The most commonly reported AEs which are commonly seen in prostacyclin therapy included cough (48%), headache (29%), throat irritation (16%), dizziness (12%), chest discomfort (11%), diarrhea (10%), nausea (7%), flushing (7%), dyspnea (6%), and oropharyngeal pain (5%). The rate of AEs was higher in prostanoid-naïve patients (85%) than in transition patients (73%), as expected.
A total of 21 patients experienced serious AEs during the study but these were deemed as not treatment-related by the study’s medical monitor. No relevant clinical findings were observed for physical exams, vital signs, or clinical lab work.
The INSPIRE trial enrolled a total of 121 patients with PAH with New York Heart Association functional class 2 or 3 at the time of screening. Of these patients, 45.5% were transitioning from Tyvaso and the other 54.5% were naïve to treatment with prostanoids. The majority of patients in the study were female (81.8%) and the mean age was 54 years.
LIQ861 is a dry powder formulation of treprostinil (a prostacyclin analog) delivered through a compact, disposable inhaler. Using PRINT® technology, LIQ861 is composed of uniform 1.2 µm trefoil-shaped particles. According to a previous phase 1 pharmacokinetic trial, 79.5 mcg of LIQ861 delivers a comparable exposure to 9 breaths of Tyvaso.
References
Liquidia announces presentations at the 2022 American Thoracic Society (ATS) International Conference. News release. Liquidia Corporation; May 16, 2022.
Hill NS, Feldman JP, Sahay S, et al. Safety and tolerability of LIQ861 in pulmonary arterial hypertension (PAH): results from INSPIRE study at 1 year. Minisymposium presented at: American Thoracic Society (ATS) International Conference; May 15, 2022.
Hill NS, Feldman JP, Sahay S, et al. Safety and tolerability of LIQ861 in pulmonary arterial hypertension (PAH): results from INSPIRE study. Poster presented at: American Thoracic Society (ATS) International Conference; May 16, 2022.
