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news.The US Food and Drug Administration (FDA) Office of Orphan Products Development has granted an orphan drug designation to Promedior's PRM-151, used for the treatment of idiopathic pulmonary fibrosis (IPF).
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PRM-151 (rhPTX-2) is a recombinant form of human Pentraxin-2, an endogenous human protein that treats fibrosis by regulating the monocyte-derived cells.
In a Phase 1 clinical study, PRM-151 was found to be safe and well tolerated, and showed activity against efficacy biomarkers through reductions in IPF-related blood fibrocytes levels and serum IL-6 levels.
Currently, PRM-151is being evaluated in a Phase 1b clinical study in IPF patients for safety, tolerability and biological activity on exploratory pharmacodynamic and prognostic biomarkers of IPF progression.
Promedior president and chief executive officer Dominick Colangelo said the designation positions Promedior to continue the rapid development of PRM-151 for the treatment of rare systemic fibrotic diseases.
The numerous validated models of fibrotic and neovascular disease also confirmed the ability of Pentraxin-2 therapeutics to treat fibrovascular diseases.