Firm’s iCALM treatment approach is designed to support inherent lung defense mechanisms.

Respiratory disease therapeutics firm Pulmatrix raised $14 million in a Series B1 round of financing with existing investors including Polaris Venture partners, 5AM Ventures, Arch Venture Partners, and Novartis Venture Fund. The firm says it will use the funds to progress its lead inhaled cationic airway lining modulator (iCALM) drug candidate, PUR118, through Phase II trials in the treatment of both COPD and cystic fibrosis (CF).

Phase Ib studies with the inhaled dry powder-formulated PUR118 have recently been initiated for the COPD indication. A clinical study evaluating PUR118 in CF patients is planned for the near future.

Pulmatrix’ iCALM platform is designed to stimulate the lung’s natural defense mechanisms to prevent infection, enhance the clearance of pathogens, and reduce airway inflammation. Rather than center on the development of single treatments for individual pathogens, effectively the “one drug, one bug” approach, the firm’s iCALM technology is pathogen independent. It is designed to reduce chronic airway inflammation via a dual mechanism of action that enhances and stimulates the natural biophysical and biochemical properties of the airway.

Pulmatrix believes this approach has the potential to prevent and treat a range of respiratory infections, including chronic respiratory diseases such as COPD, asthma, and cystic fibrosis, as well as respiratory infections such as influenza, influenza-like illness, rhinovirus, ventilator-associated pneumonia, and respiratory syncytial virus in both compromised and healthy individuals. Both liquid and dry powder-based formulations of iCALM drugs are in development for a range of respiratory indications.

A Phase I trial evaluating PUR003, which is a liquid product candidate comprising the same active drug as PUR118, was completed in asthma patients in May. The firm says combined Phase I results to date, including those from studies with PUR118 in healthy volunteers and PUR003 in both healthy volunteers and in patients with asthma, all demonstrated favorable safety and tolerability.

“Our clinical data to date suggest that our novel iCALM therapies including our most advanced formulation PUR118 will be well tolerated in the targeted patient populations with inflammatory airways conditions,” says John Hanrahan, M.D., Pulmatrix’ CMO. “iCALM is uniquely suited to address respiratory exacerbations: the most serious threats to patients with inflammatory airways conditions. iCALM delivers this important therapeutic benefit to patients by the combined effects of reducing airway inflammation, augmenting airway clearance, and priming the airway’s innate defenses to combat respiratory pathogens.”

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