Pentixapharm Prepares for Phase 3 PANDA Study on Hypertension Diagnostic

Pentixapharm Holding AG is advancing its Phase 3 PANDA study for the diagnostic candidate 68Ga-PentixaFor in treatment-resistant hypertension. Following a Type B pre-IND meeting, the FDA provided initial feedback on the study's draft protocol. This guidance includes proposed inclusion criteria, design, and statistical parameters, crucial for advancing their Investigational New Drug submission.

The candidate, [68Ga]Ga-PentixaFor, targets CXCR4 using PET/CT imaging, potentially enhancing diagnostic accuracy for primary aldosteronism, a condition often linked to secondary hypertension but historically underdiagnosed. Pentixapharm aims to finalize their Phase 3 study design post-receiving the FDA's formal meeting minutes.

This development aligns with Pentixapharm's strategy to advance precision diagnostics in oncology and cardiology. Their pipeline emphasizes CXCR4-targeted programs, aiming to better guide treatment decisions through improved diagnostic tools.