INFLAZYME REPORTS OUTCOME OF ASTHMA TRIAL REVIEW

Inflazyme Pharmaceuticals has announced the outcome of a review of the Phase IIb CAPSICS study of IPL512,602, which showed no statistical or clinical difference between patients who received drug or placebo. The company announced the negative study results in January.

The placebo response was "surprisingly large" and consistent across a number of endpoints, which prompted an examination to determine if anything "untoward" had occurred during the study. Experts have offered three possible factors contributing to the high placebo response.

First, the study did not include placebo treatment during the run-in period at the start of the trial when patients were to be stabilized on their existing therapy. Observing a large placebo effect during this run-in period could have excluded those patients from the study.

Second, subjects were on a background therapy of inhaled corticosteroids, and it is not possible to determine if there may have been compliance issues whereby patients were not taking their medications on a consistent basis during the study.

Finally, a large proportion of the patients were recruited during the summer allergy season, and the patients' allergies might have diminished during the treatment phase of the trial as the allergy season waned.

The company also believes that IPL512,602 would benefit from additional clinical investigation to confirm its potential as an oral treatment for asthma, owing to significant data from the earlier Phase IIa study in mild to moderate asthmatics and substantial preclinical evidence. But Inflazyme said it has insufficient cash resources to conduct additional clinical trials with this product.