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Efficacy of Asthma Drug Not Confirmed in Trial
German drugmaker Avontec’s AVT-01 decoy oligonucleotide (decoy ODN) proved safe in a Phase IIa trial of asthma patients. However, the drug’s efficacy could not be confirmed.
The results of a multiple-dose, double-blind, randomized, placebo-controlled, multicenter, multinational, unbalanced, parallel-group comparison study evaluated once-daily treatment of AVT-01 decoy ODN. The study population included 33 male moderate asthmatics treated with the candidate and 15 treated with placebo.
The primary endpoint was the reduction of bronchial hyperresponsiveness after methacholine challenge measured as the calculated PC20 difference between day seven and day zero. A secondary endpoint was the reduction of bronchial hyperresponsiveness after methacholine challenge on treatment day three.
According to the trial results, there was no significant difference on day three between the AVT-01 decoy ODN and the placebo group. There also was an unusually high standard deviation of the primary efficacy criterion, Avontec said.
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