“As a leader in radiology, we are committed to bringing forward innovations for the benefit of patients, including potential options to reduce the gadolinium dose,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development, Bayer. “We are very pleased with the positive topline results of the QUANTI studies and are looking forward to sharing the data with the scientific community.”
Bayer plans to submit a comprehensive data package which will include the QUANTI study results to health authorities worldwide to secure marketing authorization.
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About the Phase III development program for gadoquatrane
The QUANTI clinical development program consisted of two large multicenter, randomized, prospective double-blind, cross-over Phase III studies – QUANTI CNS and QUANTI OBR – as well as the QUANTI Pediatric study. In total, 808 patients in 15 countries were included in the program.
QUANTI CNS evaluated the efficacy and safety of gadoquatrane in adults with known or highly suspected pathologies of the central nervous system undergoing a contrast-enhanced MRI. In common CNS disorders, such as brain tumors, brain metastasis and multiple sclerosis, MRI plays a key role in diagnosis and treatment decisions.
QUANTI OBR investigated the safety and efficacy of gadoquatrane in contrast-enhanced MRI of all other body regions, including head and neck, thorax including the breast and the heart, abdomen, pelvis, and extremities, as well as blood vessels with magnetic resonance angiography (MRA).
QUANTI Pediatric assessed the pharmacokinetics and safety of gadoquatrane in children from birth to < 18 years of age undergoing contrast-enhanced MRI.
The design and dosing of the Phase III clinical development program was based on the positive data from the Phase II study evaluating efficacy and safety of gadoquatrane at a dose of 0.04 mmol Gd/kg body weight. The Phase II study was a multicenter, single-blind, adaptive dose-finding study of single intravenous injections of gadoquatrane with corresponding blinded review in adult patients with known or highly suspected CNS lesions referred for contrast-enhanced MRI.
About gadoquatrane
Gadoquatrane is Bayer’s investigational extracellular macrocyclic contrast agent in clinical development for contrast enhancement in MRI. This gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity.
About Radiology at Bayer
As a true life-science company with a heritage of over 100 years in radiology, Bayer is committed to providing excellence – from innovative products to high-quality services – to support efficient and optimized patient care. Bayer offers a leading portfolio of contrast media for computed tomography (CT), X-ray, and magnetic resonance imaging (MRI), along with devices for their precise administration, informatics solutions, and a medical imaging platform delivering access to applications, including those enabled by AI. Bayer’s radiology products generated about € 2 billion euros in sales in 2023. Bayer is highly committed to research and development, which includes leveraging AI and driving innovation in medical imaging.
