Bayer Healthcare Pharmaceuticals presents Phase 3 clinical data on gadobutrol

Bayer HealthCare Pharmaceuticals, Inc. today announced presentation of data in a poster titled "Results from a multicenter, open-label Phase 3 study to determine the safety and efficacy of gadobutrol, a macrocyclic 1.0 molar GBCA in patients referred for contrast-enhanced MRI of the central nervous system (CNS)" at the 48th Annual Meeting of the American Society of Neuroradiology (ASNR) in Boston, MA.  The results of this study of this investigational drug met all of its pre-specified primary efficacy objectives.  Gadobutrol is investigational in the United States and is not approved by the U.S. Food and Drug Administration.

This phase 3 study had four primary efficacy objectives.  In results comparing unenhanced CNS MRI versus the combined unenhanced and gadobutrol-enhanced CNS MRI, statistically significant superiority (P<0.0001) of gadobutrol images compared to unenhanced images was shown for all three individual blinded readers as well as the average blinded reader for three of the primary efficacy variables (internal morphology, degree of contrast enhancement and border delineation).  Non-inferiority was the objective for the number of lesions detected in this study and was demonstrated for two of three blinded readers, as well as the average of the blinded readers.(1)

In the study, 14 subjects (4.1%) reported at least one adverse event which the investigators considered related to gadobutrol.  No deaths were reported during the study period, and none of the subjects discontinued from the study due to an AE.  One subject experienced a serious adverse event (SAE), which was not considered by the investigator to be related to the study drug.

"This was a large multicenter study that included patients referred to contrast-enhanced MRI of the central nervous system based on clinical symptoms and results from previous procedures," said Juan Gutierrez, MD, Assistant Professor of Radiology, Neuroradiology Section, Director, Clinical Trials Division, the University of Texas Health Science Center at San Antonio.  "We are pleased to be presenting the data from this study at the ASNR meeting."

"The results from this Phase 3 study are an important milestone in our overall development program and in our approach to gain regulatory approval for gadobutrol in the United States," said Thomas Balzer, MD, Vice President, Global Clinical Development, Diagnostic Imaging, Bayer HealthCare.