Bayer has announced positive results from the Phase 3 QUANTI studies that evaluated gadoquatrane, an investigational gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI).
Gadoquatrane is an extracellular macrocyclic contrast agent for MRI.
The MRI agent was tested at a dose of 0.04 mmol Gd/kg body weight, reducing gadolinium by 60% compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.
It successfully met all the primary and secondary endpoints in all QUANTI studies.
The QUANTI programme included two Phase 3 studies, QUANTI CNS for the central nervous system and QUANTI OBR for other body regions in adults.
It also featured QUANTI Pediatric, which assessed pharmacokinetics and safety in paediatric patients from birth to under 18 years old across all body regions.
In QUANTI CNS and QUANTI OBR, researchers compared MRI scans using gadoquatrane to non-contrast scans and those using macrocyclic GBCAs.
Topline results showed gadoquatrane met primary and secondary endpoints for visualisation parameters and lesion detection.
QUANTI Pediatric results confirmed gadoquatrane’s pharmacokinetics in children are similar to those in adults.
The safety profile of the MRI agent in both adults and paediatric patients in the QUANTI studies was consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed.
Bayer radiology research and development head Konstanze Diefenbach said: “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.
“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, including QUANTI study results, to global health authorities for marketing authorisation.
In a separate development, the Bayer announced the submission of marketing applications for finerenone to the US Food and Drug Administration (FDA) and in China for adults with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%.
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA).
Already marketed as Kerendia or Firialta in over 90 countries, it is approved for treating chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
