Vancouver, BC – January 21, 2004 – Anti-infective drug developer Micrologix Biotech says it has met with the United States Food & Drug Administration (FDA) to address the regulatory requirements for a new drug application (NDA) for MBI-226. The drug is a topical cationic peptide currently in phase III development for the prevention of catheter-related bloodstream infections.
The company says an NDA path forward for MBI-226 can be achieved without requiring a statistically significant reduction in catheter-related bloodstream infections as a primary endpoint. The NDA requirements for MBI-226, which may include a confirmatory second phase III study, will be established in consultation with an FDA representative over the next several months, using the secondary endpoints from a first phase III study completed in July 2003 as a basis for seeking approval.
In the completed phase III study, it says MBI-226 achieved a clear, statistically significant reduction in the two secondary efficacy endpoints of the study catheter colonization (p=0.002) and catheter-related local infections (p=0.004) – as compared to povidone-iodine. These two endpoints are documented in published literature to be related to the development of catheter-related bloodstream infections. The primary endpoint, a reduction in catheter-related bloodstream infections, resulted in a 15% improvement as compared to povidone-iodine, which was not statistically significant.
Fujisawa Healthcare, the development partner for MBI-226, has elected to terminate their agreement and will return all rights pertaining to MBI-226 to Micrologix, including all clinical data, manufacturing development, and the investigational new drug (IND) application filed with the FDA.
“While we are disappointed that our partnership with Fujisawa will not continue, the outcome of the FDA meeting shows a viable regulatory path forward exists for MBI-226, based on the secondary endpoints from the previous phase III study,” says Jim DeMesa, MD, president & CEO of Micrologix. “Our intent is to advance the program with a commercialization partner, and we are actively pursuing opportunities with companies expressing an interest in MBI-226; a Phase III product opportunity with a path to NDA and a high degree of statistically proven efficacy in a pivotal phase III study.”