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. Resolution of allergic rhinitis could improve asthma symptoms and other measures of asthma control in all patients independent of treatment.
Our Phase 2b study was of a standard design generally used in this setting, such that these issues were not anticipated. However, taken together, we believe these issues nullify interpretation of the Phase 2b study.
Inflazyme believes that IPL512,602 would benefit from additional clinical investigation to confirm its potential as an oral treatment for asthma. The Company has significant clinical data from the earlier Phase 2a study in mild to moderate asthmatics completed by Aventis pharma (now sanofi-aventis) in June 2004, and substantial preclinical evidence indicating that the drug has efficacy in asthma. Today, Inflazyme has insufficient cash resources to conduct additional clinical trials with this product. Inflazyme plans to share these findings with other parties in an attempt to realize commercial value for this program.
Inflazyme Pharmaceuticals is a biopharmaceutical company pioneering medical breakthroughs to transform the lives of patients with respiratory and inflammatory diseases worldwide.Further information on the Company may be obtained from its website at www.inflazyme.com.
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