Pipeline Development

Aerolytic™ and Pulmolytic™ are tradenames for AER 002, a truncated 21 Kd human SPINT2 serine protease inhibitor with two Kunitz-like domains being developed for two different indications. SPINT2 is highly expressed in the human lung and preclinical testing shows Aerolytic / Pulmolytic inhibits the epithelial sodium ion channel (ENaC) via interaction with the enzyme prostasin.

AER-002

AER 002 inhibits prostasin, a protease that regulates epithelial sodium (ENaC) activity and mucociliary clearance
Aerolytic has potential for the treatment of cystic fibrosis (CF), a genetic condition that affects approximately 70,000 people worldwide. Pulmolytic is being developed for treatment for chronic obstructive pulmonary disease (COPD) which affects nearly 4% of the world's population. Inhibition of ENaC by Aerolytic / Pulmolytic has the potential to normalize the fluid abnormalities in the lung of affected patients and thereby prevent or slow disease progression.

Clinical Development Summary:

Aerolytic completed a Phase 2a study in CF patients. Pulmolytic also completed a Phase 2a study in COPD patients. Both studies confirmed biologic activity of AER 002.