EMA Grants PRIME Status to Pentixapharm’s Lead Candidate PentixaFor
Disclosure of Insider Information according to Article 17 of Regulation (EU) No. 596/2014
Würzburg and Berlin, Germany, October 18, 2024 - The European Medicine Agency (EMA) has granted PRIME Status to Pentixapharm’s lead candidate Ga68-PentixaFor, thereby granting an early and proactive support for the development of the radiodiagnostic and the possibility of an accelerated approval. The benefits of PRIME status include an early appointment of CHMP or CAT rapporteurs, iterative scientific advice on development plans, introductory meeting on regulatory requirements, and potentially a total fee exemption for scientific advice. The status also confirms that PentixaFor has the potential to address, in primary aldosteronism (PA), an unmet medical need to a significant extent.
PentixaFor is a novel tracer for positron emission tomography (PET) imaging targeting the C-X-C receptor 4 (CXCR4). High expression of CXCR4 has been identified in aldosterone-producing tissue, which is responsible for the aldosterone over-secretion that causes PA. PentixaFor aims to be a non-invasive and accurate alternative to adrenal venous sampling (AVS), the current invasive and difficult Standard of Care procedure, offering the potential to transform diagnostic subtyping in PA.
PRIME is a status granted by the EMA for promising medicines that target an unmet medical need with the goal of optimizing these medicines’ development. The PRIME scheme is based on enhanced interaction and dialogue between EMA and Sponsor, to improve the development plans and speed up the evaluation, so that the medicines can earlier reach the patients. In particular, the PRIME scheme allows iterative scientific advice on the overall development plans and key issues, expedited follow-up scientific advice with shortened timelines, and potential accelerated assessment at the time of application for a marketing authorization. Since the start of the program in 2016, only 139 applications were granted, with Ga68-CXCR4 being the first radiodiagnostic.
Primary aldosteronism, also known as Conn’s syndrome, is an adrenal gland disorder and the most common cause of secondary hypertension. However, it remains difficult to diagnose and to effectively treat with current methods. Pentixapharm is currently preparing a Phase III pivotal study to obtain marketing authorization in PA that will start in 2025.
About Pentixapharm
Pentixapharm is a clinical-stage radiopharmaceutical development company with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceuticals for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.
Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a Phase III registration study with PentixaFor in PA that will start in Europe and in the United States in 2025.
For more information, please contact:
Pentixapharm Holding AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com