Citius Announces Change to Primary Endpoint in Mino-Lok® Study

Citius Pharmaceuticals reported the U.S. Food and Drug Administration (FDA) responded to the Company's proposal to refine the endpoints in the current Phase 3 pivotal trial for Mino-Lok.

The current Phase 3 trial being conducted compares Mino-Lok therapy (MLT) to antibiotic lock therapy (ALT) to not only disinfect colonized catheters causing bacteremias, but also to keep the treated catheters functioning and infection free for 8 weeks post therapy.

The new proposed primary endpoint is planned to demonstrate a significant difference in the time to catheter failure when comparing MLT to ALT. This is clinically important because eliminating the source of infection enables antibiotic treatment of the bacteremia to work more effectively and expeditiously. Additionally, if a catheter can be maintained for the time that it is needed, the patient does not need to be subjected to the procedures for removing and replacing the catheter that are associated with some serious adverse events.

The FDA noted that time to catheter failure is an acceptable primary efficacy endpoint. They also instructed the Company to identify and consider the various types of reasons for catheter failure, and to show the clinical significance of this endpoint.

"Citius is very pleased about the change in efficacy endpoints," said Myron Holubiak, President and CEO of Citius. "We believe this focus will allow us to demonstrate the real benefit of Mino-Lok therapy (MLT) which is that MLT works more efficiently and expeditiously to break up biofilm and eliminate the bacteria causing the bacteremia than current antibiotic lock therapies (ALTs). We now have a clearer way forward to prove the superior efficacy of Mino-Lok to ALTs, and we believe we can do this faster with fewer patients than originally planned. At this time Citius believes that the change to the primary endpoint will result in fewer than 150 total subjects in Phase 3 trial. These changes would enable Citius to realize clinical trial cost savings approaching $10 million."

The Company has recently submitted a response to the FDA with the new sample size estimate which the agency is reviewing.

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