Eckert & Ziegler Subsidiary Pentixapharm Receives FDA Feedback to Initiate Phase III Trial with PentixaFor

Pentixapharm AG, a company owned by Eckert & Ziegler SE, has received positive feedback from the FDA to start a Phase III trial with the radiopharmaceutical Ga68-PentixaFor in Primary Aldosteronism (PA). PA, known as Conn’s syndrome, is a common cause of secondary hypertension.

The feedback from a recent Type C meeting suggests that existing clinical data may support the trial, potentially eliminating the need for a second clinical investigation. Ga68-PentixaFor meets criteria for fast track and breakthrough designation, accelerating its investigational new drug (IND) application.

Ga68-PentixaFor is a PET imaging tracer for detecting aldosterone-producing adenomas in PA patients. The approval could provide a non-invasive alternative to adrenal venous sampling, which is the current standard but is invasive and complex.

Dr. Dirk Pleimes of Pentixapharm stated that this milestone enables them to proceed with a US-centric Phase III trial. The aim is to improve diagnostic accuracy in Primary Aldosteronism and patient outcomes.