AR-501 Enrolls First Subject in Trial for Treatment of CF Chronic Lung Infections

Aridis Pharmaceuticals announced the first subject has been enrolled in a Phase 1/2a clinical study evaluating the investigational candidate AR-501 for treatment of chronic bacterial lung infections in patients with cystic fibrosis (CF).

"We are pleased to initiate this exciting program with the first subject enrolled," said Wolfgang Dummer, M.D., Ph.D., Chief Medical Officer of Aridis. "Through this trial, we anticipate safety, pharmacokinetic, and exploratory efficacy data that will enable us to further explore the potential of AR-501 in the treatment of these life-threatening bacterial infections in cystic fibrosis patients."

The AR-501 study is a randomized, double-blinded, placebo controlled single and multiple dose-ascending Phase 1/2a clinical trial investigating the safety and pharmacokinetics of inhaled AR-501 (gallium citrate) in healthy volunteers and cystic fibrosis patients with chronic bacterial lung infections. The study will accrue 48 healthy adult volunteers and 48 cystic fibrosis patients from approximately 15 sites in the U.S. Phase 1 data are anticipated during the fourth quarter of 2019 and Phase 2a data are anticipated for the fourth quarter of 2020. The lead investigator for the study is Dr. Noah Lechtzin, Director of the Adult Cystic Fibrosis Program and Associate Professor of Medicine at Johns Hopkins University.

"The recent safety and efficacy demonstration of intravenous gallium from a Phase 2 clinical study in CF patients gives us optimism of the prospect inhaled delivery of gallium (AR-501), which is a more direct, local route of delivery to the site of infection in the lungs and less systemic exposure," said Dr. Dummer.   

The Phase 1/2a trial is part of a collaboration with the Cystic Fibrosis Foundation, which has committed up to $7.5 million in funding through Phase 1/2a.

AR-501 is an inhaled formulation of gallium citrate that is being developed to treat chronic lung infections in cystic fibrosis patients. Its anti-infective mechanism of action is different from antibiotics. AR-501 acts as an iron analog and is believed to disrupt multiple iron dependent pathways in microbes, leading to growth inhibition. AR-501 has antimicrobial activities against a number of gram-negative and gram-positive bacteria, including antibiotic resistant strains. Preclinical studies have shown that mice infected with P. aeruginosa bacteria can be rescued from mortality with a single inhalation exposure of aerosolized AR-501. This drug candidate is being developed as a once-per-week dosing regimen that is self-administered using a hand-held nebulizer device. The planned Phase 1/2a clinical study involves single and multiple ascending dose cohorts that are drawn from the healthy adult volunteers as well as cystic fibrosis adult patients.

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