Palladio Biosciences Announces Presentations of ELiSA Phase 2 Study Results and Phase 3 Lixivaptan Clinical Program Design during the American Society of Nephrology Kidney Week 2019 Meeting

NEWTOWN, Pa.–(BUSINESS WIRE)–Palladio Biosciences, Inc. (Palladio), a privately-owned, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney, announced today that preliminary results of the ELiSA Phase 2 study of lixivaptan for the treatment of Autosomal Polycystic Kidney Disease (ADPKD) and the clinical design and main elements of the Phase 3 registrational program for lixivaptan in patients with ADPKD will be presented in two poster sessions during the American Society of Nephrology’s Kidney Week 2019, to be held in Washington, D.C. on November 7-10.

Full details will be discussed during the presentations but, briefly, the ELiSA Phase 2 trial evaluated the effect of two doses of lixivaptan on pharmacodynamic biomarkers that are indicative of vasopressin V2 receptor inhibition in patients with ADPKD. Results confirmed that the lixivaptan doses tested in the ELiSA study bracket the intended titration dosing range for lixivaptan in the planned Phase 3 registrational program. In addition, the high dose of lixivaptan tested in the ELiSA Phase 2 study showed an effect on predictive pharmacodynamic markers of clinical efficacy that was comparable to the effect measured with FDA-approved members of the class. In particular, lixivaptan caused prolonged declines in urine osmolality, which indicated effective vasopressin inhibition over extended time periods. Lixivaptan exhibited a good safety and tolerability profile.

The second presentation will present the main elements of the planned Phase 3 clinical program with lixivaptan for the treatment of patients with ADPKD. The program will include a Phase 3 registration trial consisting of a randomized, double-blind, placebo-controlled phase (Part 1) and an open-label phase (Part 2) as well as an open-label safety study in ADPKD patients who experienced liver function test abnormalities while taking tolvaptan for ADPKD. At this point in time, Palladio is actively seeking clinical sites with access to patients who will fit the criteria for the latter study.

Details for the accepted poster abstracts are listed below. They can be accessed online on the conference website with the associated hyperlink.

1. Effect of Lixivaptan on Pharmacokinetic (PK) and Pharmacodynamic (PD) End Points in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) in the ELiSA Study (PA-102)
   
   Poster Number: TH-PO844
   
   Presentation date/time: November 7, 2019 / 10:00 AM – 12:00 PM
   
   Location: Exhibit Hall, Walter E. Washington Convention Center
   
   https://www.asn-online.org/education/kidneyweek/2019/program-abstract.aspx?controlId=3235422
2. A Phase 3 Clinical Program with the Novel Vasopressin V2 Receptor Antagonist Lixivaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)
   
   Poster Number: INFO10-FR
   
   Presentation date/time: November 8, 2019 / 10:00 AM – 12:00 PM
   
   Location: Exhibit Hall, Walter E. Washington Convention Center
   
   https://www.asn-online.org/education/kidneyweek/2019/program-abstract.aspx?controlId=3253072

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 near Philadelphia, PA. Palladio is initially developing its lead drug, lixivaptan, for Polycystic Kidney Disease (PKD), an orphan kidney disease for which there are limited treatment options. For more information, please visit www.palladiobio.com.

About Lixivaptan:

Lixivaptan 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 Autosomal Dominant PKD (ADPKD). Lixivaptan received orphan designation by FDA for the treatment of ADPKD and is currently being tested in the ELiSA study, a Phase 2 clinical trial in patients with ADPKD. It 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 more than 140,000 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 4^th leading cause of kidney failure. There is no cure for PKD.

Please note that lixivaptan is for investigational use only.

Contacts

Palladio Biosciences, Inc.

Linda Hogan, +1 908-294-8728

[email protected]
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