Aradigm, APT Pharmaceuticals start phase 2 program for asthma treatment

By Elaine Rigoli

Tampa, Fla., March 23 - Aradigm Corp. and APT Pharmaceuticals Inc. have started a phase 2 clinical trial investigating aerosolized hydroxychloroquine (HCQ) as an anti-inflammatory treatment for asthma.

This clinical program will investigate the safety and efficacy of a novel aerosolized formulation of HCQ using Aradigm's AERx pulmonary delivery system, according to a company news release.

The phase 2 trial is a randomized, double-blind, placebo-controlled, multi-dose study in patients with asthma. The trial will enroll about 100 patients with moderate-persistent asthma who will be randomized to one of two treatments groups: either an aerosolized placebo or an aerosolized HCQ given once daily for 21 consecutive days, the release said.

Both treatment groups will be administered via the AERx system with efficacy, safety and tolerability assessments being performed throughout the study.

The trial is being conducted at multiple study sites and follows favorable data from a phase 1 human trial completed last year with AERx and a previously executed pre-clinical study both using an aerosolized formulation, the release said.

Aerosolized HCQ enables delivery of the drug directly to the lower airways and in preclinical studies has been shown to dramatically reduce the time required to achieve improvement in airflow from months, as seen with the oral formulation, to a few days.

"Given HCQ's classification as a disease modifying antirheumatic drug, we are optimistic that our aerosolized HCQ delivered to the lung with Aradigm's AERx system will show rapid therapeutic benefit to asthmatic patients," APT president Gino Disciullo said in the release.

Tucson, Ariz.-based APT is a clinical-stage company developing products to treat respiratory diseases.

Hayward, Calif.-based Aradigm develops non-invasive delivery systems that enable patients to self-administer biopharmaceuticals and small molecule drugs.

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