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.

Truncated 22kDa form of a human protease inhibitor SPINT2 Aerolytic™/Pulmolytic™ inhibits Prostasin, a protease that regulates epithelial sodium channel (ENaC) activity and mucociliary clearance

Aerolytic™ is being developed for the treatment of cystic fibrosis (CF), a genetic condition that affects 70,000 people worldwide. Pulmolytic™ is being developed for treatment for chronic obstructive pulmonary disease (COPD) which effects 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 disease progression. Aerolytic™ completed Phase I in CF patients this year and is now in Phase IIa. Pulmolytic™ is also currently in Phase IIa in COPD patients.

 

AEROLYTIC™ DEVELOPMENT PROGRAM

• A Phase IIa study of Aerolytic™ is being conducted in patients with cystic fibrosis.
• If effective and well-tolerated, large scale cystic fibrosis studies will be commenced for FDA approval.

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