The Aridis Pharmaceuticals Inc (NASDAQ: ARDS) stock price rallied 56.3% after its phase 2a study of AR-501, evaluating the safety and pharmacokinetics of three ascending doses of AR-501 met its primary and secondary endpoints.
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The clinical trial recruited cystic fibrosis (CF) patients suffering from the Pseudomonas aeruginosa bacteria and other infections. AR-501 was administered once a week as an inhaled aerosol via a self-administered dosing regimen using a commercial nebuliser device.
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Investors cheered the announcement, as evidenced by the rally in ARDS stock price and the over 9.07 million shares that had changed hands at the time of writing. The weekly doses of AR-501 tested were 6.4mg, 20mg, and 40mg. The CF patients tolerated all the dosages well.
The phase 2a study results showed that cystic fibrosis patients achieved a high absorption of AR-501 in the respiratory tract, as measured by sputum concentrations. The absorption levels were over 50-fold higher than the amounts required to inhibit the target bacteria P. aeruginosa.
Vu Truong, PhD, Aridis Pharma’s CEO, said: “Having met the primary and secondary endpoints of this study, we thank the Cystic Fibrosis Foundation for the tremendous support they’ve provided to help us complete this study. The attractive safety profile of AR-501, combined with the recent results from our AR-301 mAb Phase 3 program in older adults with ventilator-associated pneumonia, provide Aridis with two promising first-in-class, novel anti-infectives.”
The company plans to hold discussions with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) to plan the structure of the subsequent definitive studies for the above programs that could lead to the official licensing of the treatments.
Hasan Jafri, MD, Aridis’ Chief Medical Officer, said: “We are very pleased to see the safety and tolerability that we had observed in healthy volunteers also confirmed in CF patients. The high drug level achieved in the lungs along with low systemic exposure from inhaled delivery effectively overcome the limitations of conventional intravenous delivery and provide a strong basis for a large efficacy study in CF and other lung infections.”
*This is not investment advice.
The Aridis Pharma (ARDS) stock price.
The Aridis Pharmaceuticals (ARDS) stock price rallied 56.32% to trade at $0.72, from Friday’s closing price of $0.46.
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