Aridis Pharmaceuticals Inc (NASDAQ:ARDS) announced Friday that its inhaled treatment for lung infections caused by cystic fibrosis has been granted Orphan Drug Designation by the European Medicines Agency (EMA).
Orphan Drug Designation is awarded to companies developing treatments for life-threatening or debilitating conditions that affect fewer than 1 in 10,000 people. It affords Aridis a 10-year period of exclusive marketing for its drug AR-501 in the European Union and reduced fees from the EMA during product development.
In June, the drug earned a similar orphan status from the US Food and Drug Administration.
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"Receiving orphan designation from the EMA for AR-501 is an important step in ensuring the program is well positioned from a global regulatory development pathway standpoint as we continue to advance its ongoing Phase 1/2a clinical trial," Aridis CEO Vu Truong said.
"We remain on track to report data from the Phase 1 segment of the trial consisting of healthy subjects in Q1 2020 and the Phase 2a portion with cystic fibrosis subjects in Q2 2021."
Cystic fibrosis is a genetic disease that leaves the lungs in an imuno-compromised state, leading to frequent infections. AR-501 is being developed as a weekly inhaled treatment, and preclinical data has shown its safety when used in conjunction with antibiotics.
The San Jose, California company’s stock climbed 3.2% to $10.12 on Friday.
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