Liquidia Releases Exploratory Endpoint Data from INSPIRE Study at the American Thoracic Society (ATS) Annual Meeting
LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed and engineered using Liquidia’s novel PRINT technology with the goal of enhancing deep-lung delivery of treprostinil in PAH patients by means of a convenient, palm-sized dry powder inhaler.
The data from the INSPIRE study were made available via a prerecorded poster session and showed results from standard measures used to evaluate clinical symptoms and functional ability, which were exploratory endpoints and not subject to formal statistical analysis. Overall, improvements from baseline following treatment with LIQ861 for two months included an increase in six-minute walk distance (6MWD); clinically meaningful reduction (improvement) in the Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ) total score; lower (improved)
“We are very pleased with the results of LIQ861 on these exploratory endpoints and believe these findings warrant further evaluation in this difficult to treat patient population,” said
INSPIRE, a phase 3, open-label, multicenter study of two
The initial dose for transition patients (n=55) was based on their Tyvaso® dose at the time of transition and the starting dose for add-on patients (n=66) was 26.5 mcg QID. Titration to a higher LIQ861 dose was permitted in both groups based on symptom relief at the discretion of the physicians.
Results of the exploratory endpoints evaluated in the INSPIRE study showed:
- More than 70 percent of patients were able to titrate to a LIQ861 dose ≥79.5 mcg.
- NYHA functional class improved in 20.5 percent of patients and maintained in 75.9 percent.
- Overall median 6MWD increased by 10.1 m.
- There was no clinically meaningful change in NT-proBNP.
- MLHFQ showed an improved total score (>5-point reduction), as well as in both emotional and physical dimensions.
- A larger percentage of patients met two-or-three PAH low-risk criteria at month 2 compared with baseline.
- The majority of transition patients preferred the LIQ861 dry-powder inhaler to the Tyvaso® Inhalation System.
“The PAH community has substantial unmet needs, like so many others with rare disease,” said
The INSPIRE study safety and tolerability outcomes at month 2 were recently presented at the
About INSPIRE Clinical Trial
Liquidia’s pivotal open-label phase 3 clinical trial, known as INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, was designed to evaluate patients
The primary objective of the INSPIRE study was to evaluate the long-term safety and tolerability of LIQ861 and was observed to be well-tolerated in 121 patients, with 113 patients (93 percent) completing their two-month visit. During that period, LIQ861 was evaluated at doses ranging from 26.5 mcg to 159 mcg with no study-drug related serious adverse events observed. Reported treatment-emergent adverse events (“TEAEs”) were mostly mild to moderate in nature, the most common (reported in ≥4 percent) being cough (42 percent), headache (26 percent), throat irritation (16 percent), dizziness (11 percent), diarrhea (9 percent), chest discomfort (8 percent), nausea (7 percent), dyspnea (5 percent), flushing (5 percent) and oropharyngeal pain (4 percent).
For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03399604.
PAH is a chronic, progressive disease caused by the hardening and narrowing of the pulmonary arteries that can lead to right heart failure and eventually death. Treprostinil is a synthetic analog of prostacyclin, a vasoactive mediator essential to normal lung function that is deficient in patients with PAH. PAH is a rare disease, with an estimated prevalence in
Liquidia is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products using its proprietary PRINT® technology to transform the lives of patients. PRINT is a particle engineering platform that enables precise production of uniform drug particles designed to improve the safety, efficacy and performance of a wide range of therapies. Currently, Liquidia is focused on the development of two product candidates for which it holds worldwide commercial rights: LIQ861 for the treatment of pulmonary arterial hypertension (PAH) and LIQ865 for the treatment of local post-operative pain. Liquidia is headquartered in Research Triangle Park, NC. For more information, please visit www.liquidia.com.
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This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs), regulatory applications and related timelines, including potential U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA) for LIQ861, the timeline or outcome related to our patent litigation pending in the
Vice President, Corporate Development and Strategy
Source: Liquidia Technologies, Inc.