Pieris Pharmaceuticals, Inc. announced that the first subject has been dosed in the phase 1 study of PRS-220, an oral inhaled Anticalin protein targeting connective tissue growth factor (CTGF) for the treatment of idiopathic pulmonary fibrosis (IPF) and other forms of fibrotic lung disease. The phase 1 dose escalation study will evaluate the safety, tolerability, and pharmacokinetics of PRS-220 in heathy volunteers. IPF affects over three million patients worldwide and approximately 130,000 patients in the United States.

Median survival is three to five years from the time of diagnosis, with standard of care conferring only modest benefit. CTGF, a protein localized in the extracellular matrix, is a driver of fibrotic tissue remodeling as a consequence of an aberrant wound healing process. Over-expression of this target in lung tissue is observed in patients suffering from IPF, and clinical data indicate inhibition of CTGF reduces the decline in lung function among these patients.

Direct administration of PRS-220 to the lung via inhalation should achieve high local concentrations, and hence a more effective inhibition of CTGF than systemically administered interventions.