Palladio Biosciences Receives FDA IND Clearance to Begin the ELISA Study, a Phase 2 Clinical Trial with Lixivaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Lixivaptan was granted orphan designation by FDA for the treatment of ADPKD. It is a potent, selective vasopressin V2 receptor antagonist, a mechanism of action that has clinical proof of concept to slow kidney function decline in adults at risk of rapidly progressing ADPKD. Lixivaptan was previously administered to more than 1,600 subjects across 36 clinical studies as part of a prior clinical development program for the treatment of hyponatremia. Palladio expects to leverage lixivaptan’s large body of data generated in the hyponatremia clinical program to accelerate the development of lixivaptan for the treatment of ADPKD.
About Polycystic Kidney Disease (PKD) – Key Facts and Figures:
PKD is an inherited genetic disease that affects thousands of people in the United States and millions globally. ADPKD is the most common type of PKD. A person with ADPKD has a 50 percent chance of passing the disease on to each of his or her children. The disease is characterized by uncontrolled growth of fluid-filled cysts in the kidney, which can each grow to be as large as a football. Symptoms often include kidney infections and chronic pain. The continued enlargement of cysts and replacement of normal kidney tissue causes irreversible loss of renal function. In the United States, approximately 2,500 new people with PKD require dialysis or a kidney transplant every year, making PKD the 4th leading cause of kidney failure. There is no cure for PKD.
About Palladio Biosciences, Inc.:
Palladio Biosciences is a privately-owned, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney and is located in Newtown, PA. For more information, please visit www.palladiobio.com.
Please note that lixivaptan is for investigational use only.
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Palladio Biosciences, Inc.
Linda Hogan, +1 908-294-8728
Source: Palladio Biosciences, Inc.