Previously, the efficacy of asthma drugs has been judged via measures of airflow obstruction, which the company suggests do not tell the whole story in terms of asthma control, or improvement in quality of life for asthma sufferers.
“There has been increasing recognition among asthma physicians that there is not a direct correlation between measures of airflow obstruction, such as FEV1 (forced expiratory volume in one second) and asthma control; with increasing emphasis on the need to control asthma symptoms and improve the quality of life,” stated Dr Kevin Mullane, president and CEO of Inflazyme.
“Consequently, we are very pleased that the FDA recognizes the importance of patient reported outcomes among the endpoints suitable for the development of new asthma products,” explained dr Mullane. “This supports our clinical strategy for the development of IPL512602, particularly for disease control and the management of symptoms.”
In April 2005, Inflazyme stated its intentions to further advance IPL512602, targeting the underlying inflammation leading to improved asthma control. In a Phase 2 asthma study completed in the summer of 2004, IPL512602 demonstrated statistically significant improvements in several markers of asthma control including quality of life measures, and decreased need for rescue medication.