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Bayer’s investigational MR contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies

Press releases may be edited for formatting or style | January 17, 2025 MRI
BERLIN--(BUSINESS WIRE)--Bayer, a global leader in radiology, today announced positive topline results of the pivotal Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane, an investigational gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). All QUANTI studies investigated gadoquatrane at a gadolinium dose of 0.04 mmol Gd/kg body weight which represents a gadolinium dose reduction of 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. Gadoquatrane successfully met the primary and main secondary endpoints of all QUANTI studies.

The QUANTI clinical development program encompassed two multinational Phase III studies, QUANTI CNS (central nervous system) and QUANTI OBR (other body regions) in adult patients, as well as QUANTI Pediatric, a study investigating pharmacokinetics and safety in pediatric patients from birth to < 18 years of age in all body regions.

In QUANTI CNS and QUANTI OBR, researchers investigated the ability to visualize and detect known or suspected disease on MRI scans using gadoquatrane (0.04 mmol Gd/kg body weight) compared to scans without contrast injection and compared to scans using macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. Topline results show that gadoquatrane met the primary and main secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection. Results of QUANTI Pediatric demonstrated that the pharmacokinetic behavior of gadoquatrane in children is similar to that in adults.
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The observed safety profile in adults as well as pediatric patients from birth to < 18 years of age in the QUANTI studies was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed.

“Contrast-enhanced MRI is a key diagnostic tool and particularly important to help define the treatment pathway for patients potentially suffering from severe illnesses such as cancer, cardiovascular disease or CNS-related disorders,” said principal investigator Prof. Julian A. Luetkens, University Hospital Bonn, Germany. “The QUANTI clinical development program is a key step in exploring a reduced gadolinium dose for patients in clinical practice while demonstrating similar efficacy to the trial comparators. This is especially important for patients in need for repeat contrast-enhanced MRI examinations as well as vulnerable populations such as pediatric patients.”

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