Würzburg/Berlin, Germany, 25 June 2024. Pentixapharm AG, a radiopharmaceutical development company wholly owned by Eckert & Ziegler SE, today announced that it has received encouraging feedback from the U.S. Food and Drug Administration (FDA) following a recent Type C meeting with the Agency to directly proceed into a pivotal phase III registration study with its radiopharmaceutical diagnostic Ga68-PentixaFor in Primary Aldosteronism (PA). PA is an adrenal gland disorder also known as Conn’s syndrome and the most frequent cause of secondary hypertension (high blood pressure).

While the FDA minutes from the Type C meeting do not constitute a formal approval of a particular development plan, they indicate that the clinical data compiled by various academic groups independently from Pentixapharm might serve as confirmatory evidence, relieving the Company of the requirement to conduct a second well-controlled clinical investigation. The minutes also confirm that Ga68-PentixaFor addresses an unmet medical need for a serious condition and therefore meets two essential criteria for fast track and breakthrough designation, which Pentixapharm can request with its Investigational New Drug (IND) submission to initiate the phase III trial.

Ga68-PentixaFor is a novel tracer used in the positron emission tomography (PET) imaging of aldosterone-hypersecreting adenomas in patients diagnosed with PA. The estimated prevalence of this disease has increased considerably over the years, exceeding 20% in some populations of resistant hypertension¹. The disorder is characterized by either a unilateral aldosterone-producing adenoma (APA) or bilateral adrenal hyperplasia (BAH). The current gold standard for differentiating these conditions is adrenal venous sampling (AVS), a complex and invasive procedure. The vast majority of patients with unilateral PA who undergo adrenalectomy after successful AVS experience complete biochemical normalization². However, there is a risk of misdiagnosing a bilateral case, in which a patient would not benefit from the removal of the gland.

Dr. Dirk Pleimes, Chief Scientific & Medical Officer at Pentixapharm AG, commented: “The FDA feedback represents a major milestone for our Company in the development of our lead diagnostic. We aim to evaluate Ga68-PentixaFor as a first-in-class, non-invasive and accurate alternative to adrenal venous sampling, offering the potential to transform diagnostic subtyping in Primary Aldosteronism and improve patient outcomes. This discussion with US regulatory authorities provided important feedback, enabling us to proceed to a US-centric registrational Phase III trial to support global authorization applications.”

About Pentixapharm AG
Pentixapharm is a radiopharmaceutical development company founded in 2019, with its headquarters in Würzburg, Germany. It is wholly owned by the Eckert & Ziegler Group, one of the world's largest providers of isotope technology for medical, scientific and industrial use.  Pentixapharm is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular and endocrine diseases.

[1] Yozamp N, Vaidya A. The Prevalence of Primary Aldosteronism and Evolving Approaches for Treatment. Curr Opin Endocr Metab Res. 2019 Oct;8:30-39. doi: 10.1016/j.coemr.2019.07.001. Epub 2019 Jul 9. PMID: 32832727; PMCID: PMC7442120.

[2] Zhou, Y., Zhang, M., Ke, S., & Liu, L. (2017). Hypertension outcomes of adrenalectomy in patients with primary aldosteronism: a systematic review and meta-analysis. BMC endocrine disorders, 17(1), 1-9.

For more information, please contact:

Eckert & Ziegler SE
Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10,
13125 Berlin, Germany
Tel.: +49 30 94 10 84-138
karolin.riehle@ezag.de, www.ezag.com 

Pentixapharm AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94 10 84 227
www.pentixapharm.com

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