FDA scientific advice meeting provides guidance on planned Phase 3 study of radiodiagnostic lead candidate in treatment-resistant hypertension / primary aldosteronism
Further details on Phase 3 clinical setup expected upon receipt of the FDA's official meeting minutes
BERLIN, DE / ACCESS Newswire / December 3, 2025 / Pentixapharm Holding AG (Frankfurt Prime Standard:PTP), a clinical-stage biotech developing first-in-class radiopharmaceuticals, has received encouraging feedback from a TypeB pre‑IND meeting with the U.S. Food and Drug Administration (FDA). The discussion addressed key elements of Pentixapharm's planned Phase 3 PANDA study with [ 68 Ga]Ga-PentixaFor, a CXCR4-directed radiodiagnostic intended to significantly improve the diagnostic pathway for patients with treatment-resistant hypertension and primary aldosteronism. Despite its substantial clinical and societal impact, primary aldosteronism remains widely underdiagnosed, and earlier, more accurate detection represents a significant unmet medical need.
During the meeting, the FDA provided initial, non-binding feedback on key components of Pentixapharm's draft Phase 3 clinical protocol, including proposed inclusion criteria and design as well as statistical parameters. The FDA's input is considered essential for the Phase 3 study to meet effectiveness and shaping the final Investigational New Drug (IND) submission.
"We appreciate the constructive dialogue with the FDA and the opportunity to align on technical details and clarify outstanding questions," said Dr. Dirk Pleimes, CEO and CMO of Pentixapharm. "The preliminary feedback supports our plan to advance [ 68 Ga]Ga-PentixaFor into Phase 3 and provides an important step toward bringing a potentially scalable and non-invasive diagnostic tool to patients with primary aldosteronism who currently lack reliable, non-invasive options. Once we have received and reviewed the formal FDA meeting minutes, we will refine our Phase 3 study design accordingly and continue to update the market as we progress along our IND strategy."
About 68 Ga-PentixaFor in treatment-resistant hypertension and primary aldosteronism
[ 68 Ga]Ga-PentixaFor is a novel gallium-68-labeled radiodiagnostic designed to selectively target and visualize the chemokine receptor CXCR4 using high-resolution PET/CT imaging. Clinical experience with [⁶⁸Ga]Ga-PentixaFor PET/CT in approximately 1,600 patients across different indications has demonstrated its ability to non-invasively image CXCR4 expression in vivo .
Recent research has shown strong CXCR4 overexpression in aldosterone-producing adrenal tumors, a hallmark of unilateral primary aldosteronism. Primary aldosteronism is a common but historically underdiagnosed cause of secondary hypertension, largely because reliably distinguishing unilateral from bilateral disease remains challenging with current diagnostic tools. Unilateral disease is typically treated by surgical removal of the affected adrenal gland whereas bilateral disease requires life-long medical therapy. By visualizing CXCR4 expression in aldosterone-producing tissue, [⁶⁸Ga]Ga-PentixaFor has the potential to support more reliable subtyping of primary aldosteronism and thereby better guide appropriate treatment decisions.
About Pentixapharm
Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.
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SOURCE: Pentixapharm Holding AG
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