NEWTOWN, PA: November 1, 2017.–(BUSINESS WIRE)–Palladio Biosciences, Inc. (Palladio) http://palladiobio.com/, a privately held biopharmaceutical company founded to develop medicines that make a meaningful impact on the lives of patients with orphan diseases of the kidney, today announced that new data for lixivaptan for the treatment of polycystic kidney disease (PKD) will be presented in two poster sessions during the American Society of Nephrology 2017 annual meeting, to be held in New Orleans, LA on November 2-5.
Briefly, the first poster presents results of an experiment that investigated the effect of lixivaptan in the PCK rat, a validated, orthologous animal model of human PKD. In this study, a beneficial effect of lixivaptan was observed consistently across all aspects of disease tested, including biochemical markers, renal morphology, and renal function.
In the second presentation, data from a large body of existing clinical and preclinical work were used to evaluate whether lixivaptan has safety and efficacy characteristics that suggest a favorable risk-benefit profile for the treatment of Autosomal Dominant Kidney Disease (ADPKD). To explore efficacy, the effect of lixivaptan on accepted pharmacodynamic markers of efficacy in ADPKD was investigated. To explore safety, a DILIsym simulation, a predictive, multiscale computational model of drug-induced liver injury, was conducted to assess the potential for hepatocellular injury compared to tolvaptan. Results supported the potential efficacy of lixivaptan for ADPKD and indicated that lixivaptan was not associated with hepatocellular toxicity at doses expected for ADPKD. Lixivaptan thus has the potential to become a safe and effective therapy for the treatment of ADPKD in a broad patient population.
Details for the accepted poster abstracts are listed below. They can be accessed online on the conference website at:
- Effects of a Novel Vasopressin V2 Receptor Antagonist on Cystic Disease Progression in the PCK Rat
Poster Number: TH-PO574
Presentation date/time: November 02, 2017 / 10:00 AM – 12:00 PM
Location: Hall G
- Lixivaptan, a Novel Vasopressin V2 Receptor Antagonist in Development for the Treatment of Autosomal Dominant Polycystic Kidney Disease
Poster Number: FR-PO326
Presentation date/time: November 03, 2017 / 10:00 AM – 12:00 PM
Location: Hall G
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 delay the progression of ADPKD. Lixivaptan was previously administered to 1,673 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 repurpose lixivaptan and advance its development 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