LEXINGTON, Mass.----Pulmatrix, a biotechnology company developing breakthrough therapies for respiratory diseases, today announced the results of a clinical study showing that an iCALM™ (inhaled cationic airway lining modulator therapy) attenuated allergen-induced bronchitis in susceptible asthmatic patients. This demonstration of iCALM's anti-inflammatory effect, as manifest by the reduction of eosinophils in the airways after allergen challenge, supports the conclusion that iCALM is a novel inhaled therapeutic with a previously unexplored mechanism of action that can lead to better control of symptoms and lung function in patients with chronic airway diseases. These clinical data were presented at the American Thoracic Society (ATS) 2012 International Conference on Monday, May 21, 2012, in San Francisco, CA.
"These data in sensitive asthmatic patients validate the potential for iCALM to control patients' symptoms and improve lung function in a number of chronic inflammatory airway conditions," said John Hanrahan, MD, MPH, Chief Medical Officer and Senior Vice President at Pulmatrix. "We are strongly committed to advancing a pipeline of iCALM therapies to treat chronic respiratory diseases, including COPD, asthma and cystic fibrosis."
"iCALM's ability to limit allergen-induced eosinophilic airway inflammation in this trial is comparable to that of other anti-inflammatory therapies that have been proven to be effective in this challenge model in asthma," said Parameswaran Nair, MD, PhD, a Canada Research Chair in Airway Inflammometry and Associate Professor of Medicine in the Division of Respirology at McMaster University in Hamilton, Canada, and the principal investigator for the trial.
Significant results of these clinical data reported at ATS included:
iCALM was shown to attenuate allergen-induced eosinophilic bronchitis, as allergen-induced percent sputum eosinophilia was significantly less after iCALM compared to placebo, with a mean difference of -9.1% (95% C.I. from -18.2% to -0.2%);
iCALM was well tolerated by all asthmatic patients in this study.
The clinical results are reported from a randomized, double-blind, cross-over trial of 7 mild atopic steroid-naïve asthmatic patients who inhaled iCALM or matching placebo (isotonic saline) for three twice-a-day doses prior to an allergen inhalation challenge to an antigen identified by skin prick test. Allergen-induced bronchitis was assessed by microscopic evaluation of the cellular content of sputum collected 8 hours after the inhaled allergen challenge. Pulmonary function endpoints, including forced expiratory volume in one second (FEV1), were monitored frequently in the hours after the challenge to track the extent of lung obstruction caused by the challenge.
Pulmatrix, Inc. is a clinical stage biotechnology company developing two novel pulmonary drug platforms, iCALM™ and iSPERSE™, for the prevention, treatment and control of respiratory diseases. iCALM (inhaled cationic airway lining modulators) is first-of-a-kind inhaled therapies to prevent and treat acute exacerbations and improve lung function in patients with chronic respiratory diseases, such as COPD, asthma, cystic fibrosis, idiopathic pulmonary fibrosis (IPF) and bronchiectasis, while also treating and preventing respiratory infections including influenza, ventilator acquired pneumonia (VAP) and respiratory syncytial virus (RSV). iSPERSE (inhaled small particles easily respirable and emittable) is a proprietary dry powder pulmonary drug delivery platform comprised of small, dense particles with unique capabilities to support efficient, reproducible lung delivery of a broad spectrum of drug classes from small molecule to macromolecule, including double- and triple-combination therapies. Pulmatrix's lead iCALM clinical candidate, PUR118, is in two on-going Phase 1b studies in patients with COPD. The Company is pursuing both proprietary and partnered applications for iCALM and iSPERSE. For additional information about Pulmatrix, please visit http://www.pulmatrix.com.