Eckert & Ziegler Subsidiary Pentixapharm Receives Encouraging FDA Feedback to Initiate Phase III Trial with PentixaFor as Radiopharmaceutical Diagnostic in Primary Aldosteronism
June 25 2024 - 6:00AM
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 SEKarolin Riehle, Investor
RelationsRobert-Rössle-Str. 10,13125 Berlin, GermanyTel.: +49 30 /
94 10 84-138karolin.riehle@ezag.de, www.ezag.com
Pentixapharm AGPhillip Eckert, Investor
Relationsphillip.eckert@pentixapharm.comTel. +49 30 94 10 84
227www.pentixapharm.com
Media Contact:MC Services AGAnne Hennecke
anne.hennecke@mc-services.euTel. +49 211 529252 22