Aradigm and APT move asthma treatment into phase II

This clinical program will investigate the safety and efficacy of a novel aerosolized formulation of HCQ using Aradigm’s AERx pulmonary delivery system.

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

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 I human trial completed last year with AERx and a previously executed preclinical study both using an aerosolized formulation.

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.

“We believe that this novel therapeutic product that combines the advantages of an innovative formulation with the AERx targeted delivery system has the potential to offer significant advantages to many patients over traditional asthma treatments,” said Dr Tunde Otulana, vice president of clinical and regulatory affairs at Aradigm.

According to Datamonitor figures, asthma is expected to affect approximately 35.1 million people worldwide by 2015. In 2004, the annual cost to treat asthma exceeded $16 billion dollars in the US alone.