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EQS-News: Eckert & Ziegler SE / Key word(s): Study
Eckert & Ziegler Subsidiary Pentixapharm Receives Encouraging FDA Feedback to Initiate Phase III Trial with PentixaFor
as Radiopharmaceutical Diagnostic in Primary Aldosteronism
2024-06-25 / 12:00 CET/CEST
The issuer is solely responsible for the content of this announcement.
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 hypertension^1. 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
normalization^2. 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
Media Contact:
MC Services AG
Anne Hennecke
anne.hennecke@mc-services.eu
Tel. +49 211 529252 22
2024-06-25 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.

Archive at www.eqs-news.com  
Language:     English 
Company:      Eckert & Ziegler SE 

Robert-Rössle-Str.10
13125 Berlin
Germany

Phone:        +49 30 941084-138 
Fax:          +49 30 941084-0 
Internet:     www.ezag.de 
ISIN:         DE0005659700 
WKN:          565970 
Indices:      SDAX, TecDax, 
Listed:       Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, 

Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1931807

End of News EQS News Service
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1931807 2024-06-25 CET/CEST

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June 25, 2024 06:00 ET (10:00 GMT)