Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the prevention, treatment and control of respiratory diseases, today announced that it has been awarded a grant for $5.7 million from the Defense Advanced Research Projects Agency (DARPA), a component of the Department of Defense (DOD), focused on identifying and advancing novel technologies to support defense of our nation's soldiers and civilian population.
Pulmatrix's proprietary inhaled cationic airway lining modulators (iCALM) technology was identified as a promising candidate for the development of novel broad spectrum therapeutics for the treatment and prevention of respiratory infections caused by weaponized, engineered or naturally occurring pathogens.
The award will support formulation development and preclinical studies to evaluate the spectrum and efficacy of lead iCALM drug candidates. The most promising formulations will be selected for IND-enabling toxicology studies leading into clinical development with the eventual goal of providing a field-deployable drug/device combination to protect the warfighter and civilians against an array of airborne threats including anthrax, tularemia, and different strains of influenza.
iCALM therapies trigger multiple distinct mechanisms that act in concert on the inherent biophysical properties and host defenses of the airway. By targeting the host with a multifactorial mechanism iCALM could provide broad spectrum efficacy against an array of pathogens with reduced potential for the emergence of resistance. This broad spectrum anti-pathogen potential is the cornerstone of meeting the goal of the DARPA 7-day Biodefense Initiative. Pulmatrix has built an impressive package of preclinical data demonstrating treatment efficacy, prophylaxis and transmission control in multiple animal species, in both viral and bacterial infections, as well as reduced inflammation in acute models of lung injury and allergic asthma. Pulmatrix has successfully completed preclinical safety studies as well as Phase I testing of iCALM in healthy normal volunteers.
"This DARPA award and the 2009 NIAID grant we received are validation of the value and utility of broad spectrum inhaled therapeutics that can treat both bacterial and viral infections, the one-size-fits-many approach. Because of the host-targeted properties of our therapy, as opposed to targeting individual pathogens, iCALM is well-suited to meet the DARPA need by enhancing the pulmonary host defense response", said Robert Connelly, Chief Executive Officer of Pulmatrix.
"The milestones of this work are focused on demonstrating the efficacy of iCALM in making multiple viral pathogens less infectious to the warfighter and civilians. This outcome will demonstrate two utilities of the technology, pathogen independence and the ability to disrupt the induction of infection. In addition, advanced formulation work supported by this grant will allow development and characterization of an optimized lead formulation well suited to the rigors of a field device in terms of ease of inhalation and climate tolerance," said Robert Clarke, Ph.D.
Pulmatrix has a number of advancing drug development programs, including ongoing and planned clinical trials in chronic respiratory diseases including COPD, asthma, and cystic fibrosis for drug candidates that are designed to prevent acute exacerbations associated with these diseases.
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