about iCALM therapies

Pulmatrix is developing a new class of therapies called inhaled cationic airway lining modulators (iCALM) with unique therapeutic capabilities to harness the natural defenses in the body’s airway to prevent and treat infections and acute exacerbations of chronic or progressive respiratory diseases.

safety:

PUR003, a liquid iCALM formulation, has progressed through two Phase 1 trials in healthy normal volunteers (HNV). The first in-human trial demonstrated that administration of single ascending doses were safe and well tolerated. The second trial demonstrated that seven days of dosing with PUR003 was well-tolerated in HNV inoculated with influenza virus, an impaired subject population. PUR003 is currently being evaluated in a blinded, placebo-controlled cross-over trial in asthma patients. Dry powder (DP) iCALM has demonstrated safety in multi-dose pre-clinical safety trials in multiple species and will begin Phase 1 clinical safety trials in early 2011.

mutation resistance:

iCALM therapies, due to their host-targeted multifactorial mechanism of action (MOA) and by harnessing the patient’s own immune defenses, should be less susceptible to pathogen mutation and the emergence of pathogen resistance than pathogen-targeted therapies.

mechanism of action (MOA):

iCALM therapies act uniquely through a multifactorial MOA that enhances the inherent biophysical traits of the airway to diminish pathogen entry and increase clearance while simultaneously boosting the pulmonary host defense response to augment the biochemical profile of the airway. Through the concerted action of these mechanisms iCALM acts to effectively treat respiratory infection and reduce airway inflammation associated with infection and chronic respiratory disease.

pathogen-independence:

iCALM therapies act against a wide array of respiratory pathogens and, therefore, have the potential to be used either prophylactically or early in the disease process. Disease applications for iCALM include respiratory infections such as influenza, ILI, rhinovirus, VAP, and RSV in both compromised and healthy individuals and in chronic respiratory diseases such as COPD, asthma, and cystic fibrosis, where respiratory infections are a leading cause of acute exacerbations and hospitalization.

acute exacerbation control:

iCALM therapies, because of the pathogen-independent nature of their efficacy and multifactorial MOA, have the potential to prevent exacerbations of inflammatory airway diseases triggered by viral and bacterial respiratory pathogens and allergens. These exacerbations are the most significant driver of morbidity, mortality, cost, and quality of life decrements in patients with COPD, asthma, and cystic fibrosis.