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EQS-News: Eckert & Ziegler SE
/ Key word(s): Study
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 [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 Pentixapharm AG Media Contact:
25.06.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. |
| 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 25.06.2024 CET/CEST
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