Pentixapharm Announces Peer-Reviewed Phase 2 Data Back Use of PENTIXAFOR as a Superior Non-invasive PET-Diagnostic for Primary Aldosteronism

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• In the study, [68Ga]Ga-Pentixafor PET/CT was well tolerated and demonstrated high specificity and moderate sensitivity for identifying unilateral aldosterone-producing adenomas compared with adrenal vein sampling (AVS) and surgical outcomes

• The data strengthens the clinical foundation for Phase 3 development and support the role of molecular imaging in guiding treatment decisions in the population with hypertension and underlying primary aldosteronism

BERLIN, DE / ACCESS Newswire / February 5, 2026 / Pentixapharm Holding AG (Frankfurt Prime Standard:PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced publication of new Phase 2 clinical data in the Journal of Nuclear Medicine demonstrating the potential of [68Ga]Ga-Pentixafor PET/CT as a non-invasive imaging tool for subtyping primary aldosteronism (PA), the leading endocrine cause of hypertension.

The investigator-initiated study, funded by an Australian philanthropic foundation, the CASS Foundation, and the Medical Research Future Fund, was conducted as a prospective cohort study in Australia. It evaluated [68Ga]Ga-Pentixafor PET/CT as a potential alternative to adrenal vein sampling (AVS), the current standard of care for distinguishing unilateral aldosterone-producing adrenal adenomas from bilateral disease. AVS is invasive, resource-intensive, and available only in highly specialized centers, creating barriers to timely and accurate patient stratification.

Results published online show that [68Ga]Ga-Pentixafor PET/CT demonstrated high specificity and moderate sensitivity for identifying unilateral aldosterone-producing adenomas when compared with AVS and surgical outcomes. Importantly, the imaging approach was well tolerated and strongly preferred by patients, with 28 of 29 participants indicating PET/CT as the favoured diagnostic test.

"These data provide evidence that molecular imaging with [68Ga]Ga-Pentixafor PET/CT can support accurate and patient-friendly subtyping of primary aldosteronism," said Dr. Elisabeth Ng, of the Hudson Institute of Medical Research and the Endocrinology Unit at Monash Health, the lead investigator of the study. "The high specificity observed is particularly relevant for identifying patients who may benefit from curative surgery, while the strong patient preference for PET/CT highlights the potential to expand access to and acceptance of diagnostic testing for patients with primary aldosteronism."

The study recruited adults with primary aldosteronism and an adrenal adenoma visible on CT imaging. Diagnostic performance was assessed by comparing PET-derived lateralisation indices with AVS results and biochemical outcomes following adrenalectomy. The findings support the clinical utility of [68Ga]Ga-Pentixafor PET/CT as a noninvasive decision-support tool for identifying patients who may benefit from curative surgery.

"This published data builds on earlier investigator-initiated studies, including the CASTUS Step 1 trial and demonstrates reproducible performance across independent studies and geographies. Together, these data strengthen the clinical foundation of Pentixapharm's primary aldosteronism program and support readiness for Phase 3 development," said Dirk Pleimes, CEO and CMO of Pentixapharm. "Here, at Pentixapharm, we are continuing to advance our clinical and regulatory strategy for primary aldosteronism while engaging with investigators, regulators, and potential partners to maximise the clinical and commercial impact of our molecular imaging platform."

As new therapeutic options, including aldosterone synthase inhibitors, are expected to enter the treatment resistant hypertension market, accurate and scalable subtyping of primary aldosteronism is becoming increasingly important. Noninvasive imaging solutions may play a critical role in guiding treatment decisions and optimising patient outcomes in this evolving therapeutic landscape.

The full article, titled "Identification of Aldosterone-Producing Adrenal Adenomas Using [68Ga]Ga-Pentixafor PET/CT in an Australian Cohort," is available in the Journal of Nuclear Medicine.

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 over expression in aldosterone-producing adrenal tumors, a hallmark of unilateral primary aldosteronism. Primary aldosteronism is a common but historically under diagnosed 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 the prospective phase 2 pilot study

The prospective pilot study recruited adults with PA and an adrenal adenoma visible on CT and evaluated 68Ga-Pentixafor PET/CT as a noninvasive nuclear imaging alternative to AVS, assessing its diagnostic accuracy and acceptability compared with AVS in a multiethnic population. PentixaFor was supplied by Pentixapharm AG. The study was published in the Journal of Nuclear Medicine (JNM), which is a top-ranked peer-reviewed publication covering molecular imaging, PET/CT, and theranostics [Ng E, Jong I, Lau KK, Akram M, Morgan J, Nelva P, Simpson I, Haskali MB, Fuller PJ, Shen J, Yang J. Identification of Aldosterone-Producing Adrenal Adenomas Using [ 68 Ga]Ga-Pentixafor PET/CT in an Australian Cohort. J Nucl Med. 2026 Jan 29:jnumed.125.271006. (doi: 10.2967/jnumed.125.271006. Epub ahead of print. PMID: 41611475].

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