Pentixapharm Holding (Frankfurt Prime Standard: PTP) announced the submission of an Investigational New Drug (IND) application to the FDA for its lead CXCR4-targeted diagnostic program in treatment resistant hypertension with underlying primary aldosteronism.
According to Pentixapharm, the IND supports the initiation of the U.S.-focused Phase 3 PANDA clinical trial evaluating its novel imaging approach to guide treatment decisions in primary aldosteronism, enabling precise subtype differentiation and selection of the appropriate therapeutic pathway, and representing a key near-term value driver for the company.
In a statement, Dirk Pleimes, CEO of Pentixapharm, commented, “This IND submission marks an important value inflection point as we advance our flagship PANDA program into late-stage clinical development in cardiovascular disease. We are executing a focused and capital-efficient strategy to bring our lead diagnostic asset into Phase 3 while continuing to advance a broader pipeline of CXCR4-targeted programs across cardiovascular and oncology indications. With regulatory alignment, we will be able to prepare for the next phase of clinical development and expand our strategic footprint in the U.S., while engaging with potential partners and evaluating financing options to support this next stage of growth. We see significant market expansion in hypertension with underlying primary aldosteronism driven by increasing recognition of primary aldosteronism and the need for accurate subtype identification to guide treatment decisions.”
