Phase 1b trial validates efficacy of Pulmatrix PUR118 to treat COPD

Pulmatrix, Inc., a clinical stage biotechnology company creating novel inhaled therapeutics, today announced top line results from a clinical study showing that the novel inhaled therapeutic, PUR118, demonstrated anti-inflammatory efficacy and was well-tolerated in two Phase 1b studies in patients with chronic obstructive pulmonary disease (COPD). These results, that showed PUR118's beneficial impact on biomarkers of airway inflammation and mucus clearance, are the first clinical efficacy results from PUR118 which is the company's lead iCALM™ inhaled therapeutic candidate created from the iSPERSE™ dry powder delivery platform. Design aspects of these clinical trials, along with supporting and related preclinical data, were presented at the European Respiratory Society (ERS) Annual Congress on Monday, September 3, 2012, in Vienna, Austria.

“These clinical data clearly validate the potential for PUR118 to control COPD patients' symptoms and significantly improve their lung function, while also showing PUR118 to be well tolerated”

"These clinical data clearly validate the potential for PUR118 to control COPD patients' symptoms and significantly improve their lung function, while also showing PUR118 to be well tolerated," said John Hanrahan, MD, MPH, Chief Medical Officer and Senior Vice President at Pulmatrix. "Based on the strength of these initial efficacy signals, we intend to now move forward into a Phase 2 trial of PUR118 in COPD patients, accelerating this clinical program with a goal of more rapidly bringing this unique treatment approach to patients with inflammatory airway conditions and the physicians who care for them."

The presentations at ERS highlight PUR118's potential to offer a new inhaled approach for control of airway inflammation in COPD and other respiratory conditions. PUR118 clinical and preclinical data highlights include:

• A Phase 1b clinical trial that showed PUR118 was well tolerated in both healthy volunteers and patients with COPD;
• Exploratory endpoints in the Phase 1b clinical study that assess biomarkers of inflammation and mucus clearance support a favorable impact of PUR118 treatment on both airway inflammation and mucociliary airway clearance velocity;
• Phase 1b clinical data demonstrated reduction in the levels of the same critical airway inflammatory signaling molecules/biomarkers evident in preclinical models, and confirmed preclinical data on the ability of PUR118 and iCALM therapies to reduce airway neutrophilic inflammation, as reported in previous studies and those presented at ERS;
• Preclinical data from PUR118 and related iCALM studies presented at ERS demonstrated robust and consistent airway anti-inflammatory impact in animal models of a number of chronic diseases. Highlights from these preclinical studies included:
  • PUR118 reduced tobacco smoke induced chemokine and cytokine protein levels associated with neutrophilic inflammation in mouse BAL samples, suggesting that its anti-inflammatory efficacy is comparable to other clinical stage targets (p38 / PDE4) with demonstrated clinical efficacy;
  • PUR118 reduces TLR-induced chemokine and cytokine secretion and gene expression in macrophages, suggesting that the in vivo activity of PUR118 and other iCALM therapeutics is at least partially mediated through activity on macrophages.
• PUR118 was clinically evaluated in an innovative Phase 1 clinical study, and the design and implementation of the Phase 1 study were jointly presented by Pulmatrix and Quotient Clinical in a poster at ERS.

Source Pulmatrix, Inc.