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.