Insmed to Present TPIP Data at PVRI 2026 Congress, Including Phase 3 PALM-PAH Study Design
核心洞察
Insmed will present four abstracts on treprostinil palmitil inhalation powder (TPIP (搜索)) at the PVRI 2026 congress in Dublin, showcasing the Phase 3 PALM-PAH (搜索) study design and Phase 2b clinical data.
The presentations include novel Functional Respiratory Imaging analysis from the Phase 2b PAH (搜索) study and preclinical pulmonary vasodilation data in rat models.
TPIP (搜索) is being developed as a once-daily inhaled therapy for pulmonary arterial hypertension (搜索), with the Phase 2b study enrolling 102 patients across 44 sites.
Insmed Incorporated announced it will present four abstracts on its investigational therapy treprostinil palmitil inhalation powder (TPIP (搜索)) at the Pulmonary Vascular Research Institute (PVRI) 2026 congress in Dublin from January 28 to February 1, 2026. The presentations will showcase the Phase 3 PALM-PAH (搜索) study design and provide new insights from the company's Phase 2b clinical program in pulmonary arterial hypertension (搜索) (PAH).
"We are pleased that TPIP (搜索) will have a significant presence at this year's PVRI 2026 congress, reflecting the growing body of evidence supporting its potential to become the prostanoid of choice," said Martina Flammer, M.D., MBA, Chief Medical Officer at Insmed. "Collectively, these Phase 2b clinical, advanced imaging, and translational preclinical data provide a strong foundation as we initiate multiple Phase 3 programs, including the PALM-PAH (搜索) study, with the goal of improving outcomes for patients."
Phase 3 Program and Clinical Data Presentations
The congress presentations will include an encore presentation of the topline results from the Phase 2b study of TPIP (搜索) in PAH (搜索), led by Ekkehard Grünig and presented by Amy Boutet. Additionally, the Phase 3 PALM-PAH study design will be presented by Raymond Benza, providing insights into the company's pivotal trial strategy.
A novel component of the presentations includes a Functional Respiratory Imaging (FRI) analysis from the Phase 2b PAH (搜索) study, which will be presented by Ioana Preston. This advanced imaging analysis offers new perspectives on how TPIP (搜索) affects respiratory function in PAH patients.
Preclinical and Translational Research
The scientific program will also feature preclinical data evaluating the pulmonary vasodilatory effect of TPIP (搜索) in rat models, presented by Tam Nguyen. This translational research provides mechanistic insights into how TPIP works at the pulmonary vascular level.
Phase 2b Study Design and Results
The Phase 2b study was a randomized, double-blind, multicenter, placebo-controlled trial designed to evaluate the efficacy, safety, and pharmacokinetics of TPIP (搜索) administered once daily in patients diagnosed with PAH (搜索) (World Health Organization Group 1). The study was conducted at 44 sites and enrolled 102 adult participants.
Patients started at a dose of 80 µg once daily and were titrated up to their maximum tolerated dose, or to the maximum allowable dose of 640 µg, once daily over a three-week period, with the possibility of a final dose increase occurring at Week 5. Patients self-administered TPIP (搜索) or placebo using a capsule-based inhalation device.
The primary endpoint was change from baseline in pulmonary vascular resistance (搜索) (PVR (搜索)) versus placebo at Week 16. Secondary endpoints included six-minute walk distance (6MWD), N-terminal pro b-type natriuretic peptide (NT-proBNP) concentrations, pharmacokinetics, and safety/tolerability. Patients who completed the study could enroll in a long-term open-label extension, with the option to titrate up to a maximum tolerated dose of 1,280 µg once daily.
TPIP Development Program
Treprostinil palmitil inhalation powder is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP (搜索) is being evaluated as a once-daily therapy for the treatment of patients with PAH (搜索), PH-ILD (搜索), and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device and remains an investigational drug product that has not been approved for any indication in any jurisdiction.
Disease Burden and Market Opportunity
PAH (搜索) is a serious, progressive, rare disease in which the blood vessels in the lungs narrow or become obstructed, leading to high blood pressure in the pulmonary arteries. The most common symptoms include shortness of breath, chest pain, dizziness or fainting, fatigue, and weakness. It is estimated that approximately 35,000 patients in the U.S., 40,000 patients in the EU5 (France, Germany, Italy, Spain and the UK), and 15,000 patients in Japan have been diagnosed with the disease. Untreated, PAH can be debilitating and often fatal.