Pharmaxis closes U.S. phase 3 trial of Aridol in asthma diagnosis; results expected later this year

By Lisa Kerner

Charlotte, N.C., Aug. 28 - Pharmaxis Ltd. finished recruitment in its U.S. Aridol phase 3 clinical trial in people with suspected asthma.

The trial compared Aridol to known methods of diagnosing asthma in more than 400 subjects at 30 U.S. sites.

Pharmaxis said it expects initial data comparing the sensitivity and specificity of Aridol (mannitol) to identify exercise-induced bronchoconstriction, during the fourth quarter of this year.

"This large asthma trial supplements our earlier successful 650 patient study outside of the United State and the level of support amongst the U.S. respiratory physicians and their patients has been very encouraging," chief executive officer Alan Robertson said in a news release.

"I expect this study to be an important part of our marketing application for Aridol with the Food and Drug Administration."

The company believes the annual addressable market for Aridol in the United States and Europe includes the existing 400,000 annual bronchial challenge tests, 2 million new tests for assisting the diagnosis of asthma and 16 million new tests performed by pulmonary specialists and primary care physicians for disease management.

Pharmaxis is a specialty pharmaceutical company based in Sydney, Australia.

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