INSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in PULMONARY ARTERIAL HYPERTENSION (PAH) (Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil NCT03399604)

Hill, N.S.; Feldman, Jeremy; Sahay, Sandeep; Levine, D.J.; Roscigno, Robert; Vaughn, Toby; Bull, T.M.

doi:10.1164/ajrccm-conference.2019.199.1_meetingabstracts.a7402

Cited by 3 publications

(4 citation statements)

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“…A phase 3 study 45 (INSPIRE; Clinicaltrials.gov Identifier NCT03399604) to evaluate the long‐term safety and tolerability of LIQ861 in patients with PAH is under way. Interim safety and tolerability results are consistent with those reported for this phase 1 PK trial 46 …”

Section: Discussionsupporting

confidence: 83%

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Pharmacokinetics and tolerability of LIQ861, a novel dry‐powder formulation of treprostinil

et al. 2020

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A dry-powder inhaled formulation of treprostinil (LIQ861) produced using PRINTÂ® technology offers a substantial advantage over current nebulized therapy. Treprostinil is a synthetic prostacyclin analogue that is currently approved for inhalation administration to patients with pulmonary arterial hypertension (PAH) via nebulized TyvasoÂ® inhalation solution. LTI-101 was a phase 1, placebo-controlled, double-blind, randomized, single-center study that evaluated the ascending single-dose pharmacokinetics (PK) of LIQ861 in healthy subjects. Six sequential, escalating doses (25, 50, 75, 100, 125, and 150 mcg) were studied to investigate treprostinil exposure from LIQ861 inhalation. Subjects (n=57) were randomly assigned in a 3:1 ratio to receive a single dose of either LIQ861 (n=43) or placebo (n=14); 56 subjects completed all protocol-defined assessments. Following single-dose administration, treprostinil exposure from LIQ861 increased proportionally across the dose range studied, and the PK profile of treprostinil administered as LIQ861 was similar to prior reports of inhaled treprostinil. All doses of LIQ861 were generally well-tolerated with no deaths, serious adverse events, or dose-limiting toxicities. The most frequently reported treatment-emergent adverse events (TEAEs) related to study drug administration were coughing and throat irritation, which are common to dry-powder formulations. Treatment-related TEAEs were reported more frequently at higher dose levels; however, all were assessed as mild in severity. We conclude that the PK profile of treprostinil using a dry-powder inhaled formulation increased in proportion to dose as anticipated and was similar to earlier reports of inhaled, nebulized treprostinil (TyvasoÂ®). Based on these results, a phase 3 study (INSPIRE; Clinicaltrials.gov Identifier NCT03399604) evaluating the long-term safety and tolerability of LIQ861 in patients with PAH was initiated.

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Section: Discussionsupporting

confidence: 83%

“…Interim safety and tolerability results are consistent with those reported for this phase 1 PK trial. 46…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics and tolerability of LIQ861, a novel dry‐powder formulation of treprostinil

et al. 2020

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“…58,60,61 For example, data from the phase 3 INSPIRE trial for Liquidia Technologies' dry powder formulation of inhaled treprostinil (LIQ861) demonstrated safety, tolerability, and modest improvement in NYHA functional class, 6MWD (median 10 m), and quality of life. 62 Unfortunately, not all patients respond to approved PAH-specific therapy or benefit from a clinical trial; therefore, lung transplant may be the only viable treatment option. Progressive RV failure may also occur precipitously, so recommendations from the 6th WSPH provide useful guidance for bridging to transplant.…”

Section: New Targeted Treatmentsmentioning

confidence: 99%

Topic-Based, Recent Literature Review on Pulmonary Hypertension

Burger

DuBrock

Cartin‐Ceba

et al. 2021

Mayo Clinic Proceedings

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Pulmonary hypertension is a complex condition but a relatively common manifestation of severe cardiopulmonary disease. By contrast, pulmonary arterial hypertension is uncommon and is more prevalent in young women. To better categorize patients and to guide clinical decision-making, 5 diagnostic groups and associated subgroups characterize the spectrum of disease. A multidisciplinary approach to evaluation and treatment is recommended by published guidelines and often entails referral to a designated pulmonary hypertension center. Several key publications during the last couple of years merit review. The PubMed database was searched for English-language studies and guidelines relating to pulmonary hypertension. The following terms were searched, alone and in combination: pulmonary hypertension, pulmonary arterial hypertension, portopulmonary hypertension, and chronic thromboembolic pulmonary hypertension. The focus was on those publications with new information on evaluation and management of pulmonary hypertension between January 1, 2019, and January 31, 2021. Of the subgroups, 2 were of particular interest for this review: portopulmonary hypertension and chronic thromboembolic pulmonary hypertension. Last, available data on the impact of the coronavirus disease 2019 pandemic and newer treatment agents in early trials were selectively reviewed. The review is therefore intended to serve as a practical, focused review of important topics germane to those clinicians caring for patients with pulmonary hypertension.pulmonary hypertension, pulmonary arterial hypertension, right ventricular failure

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“…Fortunately, dry-powder inhalations systems are currently being tested (LIQ861, Liquida Technologies, NCT03399604). 53 Parenteral PAH therapies require proper maintenance of the intravenous or subcutaneous access, careful handling of the pump and tubing, and proficiency to reconstitute the medication. Fortunately, when patients achieve a stable dose of intravenous PGI 2 , they may consider the delivery of prefilled cassettes that reduce the time spent in preparing the medication.…”

Section: Factors Affecting Medication Adherencementioning

confidence: 99%

Treatment Discontinuation or Interruption in Pulmonary Arterial Hypertension

Narechania

Torbic

Tonelli

2019

J Cardiovasc Pharmacol Ther

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Pulmonary arterial hypertension (PAH) is a progressive disease, which can be potentially fatal. The management of a complex disease like PAH requires a multidisciplinary approach from a team consisting of physicians, nurses, social workers, and pharmacists. Adherence to PAH-specific therapy is one of the key factors in the management of this disease. Poor adherence to treatment is a common problem in PAH as it is in many chronic diseases. Management of medication interruptions is a challenge in patients with PAH that can lead to negative consequences. However, for most PAH-specific drugs, there are no clear guidelines on how to manage temporary or abrupt medication discontinuations. In this review, we summarized the available literature and provide suggestions on how to manage interruptions of PAH-specific therapies.

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INSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in PULMONARY ARTERIAL HYPERTENSION (PAH) (Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil NCT03399604)

Cited by 3 publications

References 0 publications

Pharmacokinetics and tolerability of LIQ861, a novel dry‐powder formulation of treprostinil

Pharmacokinetics and tolerability of LIQ861, a novel dry‐powder formulation of treprostinil

Topic-Based, Recent Literature Review on Pulmonary Hypertension

Treatment Discontinuation or Interruption in Pulmonary Arterial Hypertension

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