Bayer starts Phase III studies with novel contrast agent gadoquatrane

Berlin, June 27, 2023 – Bayer, a global leader in radiology, has started the Phase III clinical development program QUANTI, aiming to evaluate the efficacy and safety of gadoquatrane, a next-generation, extracellular, macrocyclic, gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). Gadoquatrane is a highly stable MRI contrast agent featuring high relaxivity that has the potential to enable a substantially lower gadolinium (Gd) dose for patients.

The QUANTI clinical development program encompasses two multinational Phase III studies, QUANTI CNS (central nervous system) and QUANTI OBR (other body regions), as well as one pediatric study, all investigating gadoquatrane at a dose of 0.04 mmol Gd/kg body weight (bw). This represents a gadolinium dose reduced by 60 percent in contrast-enhanced MRI compared to standard dosing of established products, which, if successfully tested, would constitute the lowest gadolinium dose for a multipurpose MRI contrast agent. Contrast-enhanced MRI plays a key role in the healthcare continuum, providing a radiation-free, non-invasive method of obtaining detailed images of the body, helping to distinguish and identify potential abnormalities within organs and tissues and supporting physicians in answering critical medical questions in the detection, characterization, and monitoring of disease.

“The demand for innovation in medical imaging to detect diseases, guide treatment decisions, and aid in therapy planning is growing as we see an increase in chronic diseases such as cancer and cardiovascular conditions,” said Prof. Michael Forsting, Director, Institute of Diagnostic and Interventional Radiology and Neuroradiology, University of Essen, Germany. “The QUANTI Phase III clinical program is an important step in evaluating a new option for substantially lowering the gadolinium dose while maintaining image quality, supporting accurate and timely diagnosis.”

“An estimated 59 million contrast-enhanced MRI procedures are performed annually worldwide to support doctors in accurate diagnoses for patients.¹ The broad development program of gadoquatrane underlines Bayer’s commitment, as a leader in radiology, to drive innovation for the benefit of patients and their treating physicians,” said Dr. Konstanze Diefenbach, Global Head of Radiology Research & Development, Bayer. “With gadoquatrane, we strive to advance innovation in medical imaging, including novel contrast agents, as well as new automated injection systems and AI-enabled solutions.”

About the Phase III development program for gadoquatrane
The QUANTI clinical development program consists of two large, multinational Phase III studies – QUANTI CNS and QUANTI OBR – in adults, as well as one pediatric study, investigating gadoquatrane at a dose of 0.04 mmol Gd/kg bw.

QUANTI CNS evaluates the efficacy and safety of gadoquatrane in adults with known or highly suspected pathologies of the central nervous system undergoing a contrast-enhanced MRI. Common CNS diseases are, for example, benign or malignant brain tumors and multiple sclerosis, where MRI plays a key role in diagnosis and treatment decisions.

QUANTI OBR investigates the safety and efficacy of gadoquatrane in contrast-enhanced MRI of all other body regions, such as head and neck, thorax, abdomen, pelvis, and extremities.

The pediatric study assesses the pharmacokinetics and safety of gadoquatrane in children of all ages undergoing contrast-enhanced MRI.

In total, the QUANTI clinical development program intends to enroll approximately 800 patients in 17 countries.

The design and dosing of the Phase III clinical development program is based on the positive data from the Phase II study demonstrating the efficacy of gadoquatrane with a favorable safety profile 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, read-in adult participants with known or highly suspected CNS lesions referred for contrast-enhanced MRI.

About gadoquatrane
Gadoquatrane is Bayer’s next-generation extracellular contrast agent in clinical development for contrast enhancement in MRI. This novel, macrocyclic, gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity, which has the potential to enable a lower clinical gadolinium dose in contrast-enhanced MRI for patients. It might also lead to long-term sustainable patient care, as gadolinium is a rare earth element that is not found in its pure form in nature and complex to separate.²

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 Artificial Intelligence (AI). Bayer’s radiology products generated close to €2bn sales in 2022. Based on the company’s ambition to outperform the radiology market’s average annual growth rate of 5 percent by 2030, Bayer is highly committed to research and development, which includes leveraging AI and driving innovation in medical imaging. Each of these offerings provides effective tools to support radiologists in their mission to deliver treatment-critical answers and a clear direction – from diagnosis to care.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

¹ Based on internal and external data such as IQVIA, Contrast Media Industry Group and Clarivate
² Gadolinium (Gd). By: Podeszwa, Catherine, MS, Salem Press Encyclopedia of Science, 2021; The Institute for Rare Earths and Metals: https://en.institut-seltene-erden.de/seltene-erden-und-metalle/seltene-erden/gadolinium/