Aridis Meets Primary and Secondary Endpoints in Phase 2a of AR-501 in Cystic Fibrosis Patients Study

March 13, 2023

(24/7 MARKET NEWS) – Aridis Pharmaceuticals, Inc. (Nasdaq:ARDS) announced, this morning, that preliminary top-line results from its Phase 2a study of AR-501, to evaluate the safety and pharmacokinetics of three ascending doses of AR-501 administered as an inhaled aerosol in cystic fibrosis (CF) patients with confirmed Pseudomonas aeruginosa bacterial and other potential infections.

The Company reported the following Key findings:

• The study’s primary and secondary endpoints of safety and pharmacokinetics (PK) were met

• Three weekly inhaled doses of AR-501 at 6.4mg, 20mg, and 40mg dose levels were well tolerated in CF patients. No drug related serious adverse events (SAEs) were observed. The majority of treatment emergent adverse events (TEAEs) were respiratory in nature and mostly mild to moderate in severity

• CF patients achieved high uptake of AR-501 in the respiratory tract, as measured by sputum concentrations, at levels that were more than 50-fold higher than required for inhibition of the target bacteria P. aeruginosa

• Inhaled delivery achieved more than 10-fold higher respiratory uptake of gallium (AR-501) than past clinical studies of intravenous (IV) gallium which resulted in lung function improvement and P. aeruginosa reduction.

Aridis Pharmaceuticals is trading at $0.589, up $0.129 (+28.17%), on 4 million premarket shares.

Its 52-week trading range is $0.45 to $2.77. Under normal conditions, I would state that its setup is favorable for a run to the $1.25-1.50 level, but today might not be the day.

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