Bayer initiates Phase III studies with investigational contrast agent gadoquatrane

• Gadoquatrane is a highly stable contrast agent for magnetic resonance imaging (MRI) with high relaxivity and the potential of a substantially lower gadolinium (Gd) dose¹
• Comprehensive clinical development program called QUANTI includes two Phase III studies in adults and one pediatric study investigating gadoquatrane for use in MRI across all body regions and across ages from birth to adulthood

Bayer, a global leader in radiology, has initiated the Phase III clinical development program called QUANTI, aiming to evaluate the safety and efficacy of gadoquatrane, an investigational 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 being studied to evaluate the potential of a substantially lower gadolinium (Gd) dose for patients.¹

The QUANTI clinical development program encompasses two large 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 0.04mmol Gd/kg body weight (bw). Thus, QUANTI development program investigates a gadolinium dose reduced by 60 percent compared to GBCAs dosed at 0.1mmol Gd/kg. The completion of a successful development program would demonstrate the lowest gadolinium dose for an MRI contrast agent. Contrast-enhanced MRI plays a key role in the healthcare continuum, providing a radiation-free, non-invasive method to obtain detailed images of the body, helping to distinguish and identify potential abnormalities within organs and tissues to support physicians in answering critical medical questions in the diagnosis and monitoring of disease.²

“The demand for innovation in medical imaging to support diagnosis of diseases, guide treatment decisions and aid in therapy planning is growing as we see an increase in chronic diseases such as cancer and cardiac conditions,” said Prof. Michael Forsting, Director, Institute of Diagnostic and Interventional Radiology and Neuroradiology, University Essen, Germany. “The Phase III clinical program QUANTI is an important step in establishing the safety and efficacy of an investigational agent dosed at a substantially lower gadolinium dose.”

“An estimated 13 million contrast-enhanced MRI procedures are performed annually in the United States to help inform doctors’ decisions and aid in providing diagnoses for patients.³ 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. “In addition to this potentially novel contrast agent gadoquatrane, Bayer has 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 0.04mmol 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 along 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 aged 0-18 years 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 safety and efficacy study, with a dose of 0.04mmol 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 an investigational extracellular contrast agent in clinical development for contrast enhancement in MRI. This potentially novel, macrocyclic gadolinium-based contrast agent has 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.

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.

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.

PP-CONT-US-0243-1 June 2023

References

¹ Lohrke J, Berger M, Frenzel T, Hilger CS, Jost G, Panknin O, Bauser M, Ebert W, Pietsch H. Preclinical Profile of Gadoquatrane: A Novel Tetrameric, Macrocyclic High Relaxivity Gadolinium-Based Contrast Agent. Invest Radiol. 2022 Oct 1;57(10):629-638. doi: 10.1097/RLI.0000000000000889. Epub 2022 Jun 13. PMID: 35703267; PMCID: PMC9444293.

² National Institute of Biomedical Imaging and Bioengineering. Magnetic Resonance Imaging (MRI). Retrieved June 12, 2023 from: https://www.nibib.nih.gov/science-education/science-topics/magnetic-resonance-imaging-mri.

³ Arlington Medical Resources. (2021). The Imaging Market Guide - United Stated Edition, July 201 – December 2021. Burlington, MA: Clarivate | Decision Resources Group.

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