LEXINGTON, Mass., Sept. 23, 2015 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) will report data from a Phase 1B study evaluating PUR0200, an iSPERSE formulation of a long acting muscarinic antagonist (LAMA) bronchodilator, on September 29th at the 2015 European Respiratory Society Congress. PUR0200 is being developed under the PK bio-equivalence pathway in Europe.
The two-part, single dose, placebo controlled dose-ranging clinical study in 38 patients was designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety and tolerability of PUR0200 compared to the reference product, a once daily LAMA bronchodilator. The main phase of the study was a 5-period crossover design with each patient receiving 3, 6, and 9 micrograms of PUR0200, 18 micrograms of the reference product, and an inhalation of placebo. PK results demonstrated that administration of PUR0200 resulted in dose proportional increases in plasma drug levels and all doses of PUR0200 improved pulmonary function compared to the placebo. Further, inhalation of PUR0200 3 micrograms resulted in similar PK and PD as the reference at a nominal dose that is 80% less than the reference product, demonstrating the delivery advantages of the iSPERSE™ technology. All doses of PUR0200 were safe and well tolerated.
Additional data from the study will be presented by David Hava, Ph.D., Chief Scientific Officer of Pulmatrix in a poster presentation. Details of the presentation are as follows:
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Title:
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A Phase 1 Study of PUR0200 in COPD Patients
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Date:
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September 29, 2015
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Time:
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12:50 p.m. CET
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Abstract Number:
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PA4365 (Hall 14-37; Session 434)
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Lead Investigator:
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Dr. David Singh, University of Manchester, UK
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About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF), as well as PUR1500, an inhaled product for the treatment of idiopathic pulmonary fibrosis. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD). Pulmatrix's product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
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SOURCE Pulmatrix, Inc.