Summary: Bayer’s Phase III QUANTI studies show gadoquatrane delivers comparable MRI efficacy to standard gadolinium-based contrast agents at 60% lower gadolinium doses, with consistent safety in adults and children.

Key Takeaways

  • Reduced Gadolinium Dose: Gadoquatrane demonstrated comparable MRI efficacy to standard macrocyclic gadolinium-based contrast agents while using a 60% lower gadolinium dose, highlighting its potential to minimize gadolinium exposure.
  • Broad Study Success: Across the QUANTI CNS, OBR, and Pediatric studies, gadoquatrane met all primary and secondary endpoints, with consistent pharmacokinetics in children and adults and effectiveness in lesion detection and visualization.
  • Strong Safety Profile: The safety profile of gadoquatrane aligns with previous findings for macrocyclic gadolinium-based agents, with no new safety concerns reported, supporting its suitability for repeated MRIs and pediatric use.

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Bayer has reported successful topline results from its Phase III QUANTI studies evaluating gadoquatrane, an investigational gadolinium-based contrast agent (GBCA) for MRI. The studies investigated gadoquatrane at a reduced gadolinium dose of 0.04 mmol Gd/kg body weight, representing a 60% reduction compared to macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.

Gadoquatrane’s Consistent Pharmacokinetics

The QUANTI clinical development program included three studies: QUANTI CNS (central nervous system), QUANTI OBR (other body regions), and QUANTI Pediatric, which evaluated pharmacokinetics and safety in patients from birth to under 18 years of age. Gadoquatrane met the primary and main secondary endpoints in all studies, demonstrating effectiveness in lesion detection and visualization on MRI scans.

In the QUANTI CNS and QUANTI OBR studies, researchers assessed MRI scans using gadoquatrane compared to scans without contrast and those using standard macrocyclic GBCAs. The results indicated that gadoquatrane performed comparably in efficacy, while offering a lower gadolinium dose. In the QUANTI Pediatric study, the pharmacokinetic behavior of gadoquatrane in children was consistent with adult data.

Gadoquatrane’s Potential for Repeated MRIs

The safety profile of gadoquatrane remains consistent with previous findings for macrocyclic gadolinium-based contrast agents, with no new concerns identified.

Professor Julian A. Luetkens, MD, from University Hospital Bonn in Germany, emphasizes the potential of gadoquatrane to reduce gadolinium exposure while maintaining diagnostic accuracy, making it particularly beneficial for patients requiring repeated MRIs and pediatric populations.

Bayer intends to submit the QUANTI study data for global regulatory review and potential marketing approval..