Bayer has announced results of its 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).
Gadoquatrane is an investigational extracellular macrocyclic contrast agent in clinical development for contrast enhancement in MRI. The Quanti clinical development program consisted of two large multicenter, randomized, prospective double-blind, cross-over phase III studies in three key areas: central nervous system (CNS), other body regions (OBR), and pediatrics.
For Quanti CNS and 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 with 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, according to Bayer.
Bayer said the Quanti pediatric study demonstrated that the pharmacokinetic behavior of gadoquatrane in children is similar to that in adults and was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. The company noted that no new safety signals were observed.
In total, 808 patients in 15 countries were included in the program.