German pharmaceutical giant Bayer (ETR: BAYN) announced positive results from the Phase III QUANTI CNS study for its gadoquatrane, a gadolinium-based contrast agent (GBCA), in adults with known or suspected pathologies of the central nervous system undergoing contrast-enhanced magnetic resonance imaging (MRI).
Study Details and Results
In the trials, gadoquatrane was investigated at a gadolinium dose of 0.04 mmol Gd/kg body weight, representing a 60 percent reduction compared to macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. A total of 305 patients from 16 countries across Europe, Asia, and America were enrolled. The study met all its primary and secondary endpoints. Gadoquatrane demonstrated non-inferior diagnostic efficacy to comparator macrocyclic GBCAs (gadobutrol, gadoterate meglumine/gadoteric acid, gadoteridol) dosed at 0.1 mmol Gd/kg body weight. It also showed superiority over MRIs without contrast injection based on visualization parameters. Safety events with gadoquatrane were similar to those of comparator macrocyclic GBCAs, with a low incidence of intervention-related treatment-emergent adverse events.
Company Statement
“This is a significant milestone for Bayer in the field of diagnostic imaging,” said a spokesperson from Bayer. “The positive results of the QUANTI CNS study highlight the potential of gadoquatrane to provide effective and safe contrast-enhanced MRI for patients with central nervous system pathologies.”-Fineline Info & Tech
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