–Patient enrollment into the study expected to begin by the end of June 2018–
NEWTOWN, Pa., May 8, 2018 –(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 announces that the US Food and Drug Administration (FDA) has granted Palladio Biosciences Investigational New Drug (IND) clearance to proceed with a Phase 2 clinical trial of lixivaptan capsules in patients with autosomal dominant polycystic kidney disease (ADPKD).
The ELISA Phase 2 study (Evaluation of Lixivaptan In Subjects with ADPKD), will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple doses of lixivaptan in patients with ADPKD with relatively preserved kidney function (chronic kidney disease stages CKD1 and CKD2) and moderately impaired renal function (CKD3).
The ELISA study is expected to begin enrolling patients at the end of June 2018 and is an open-label study which will enroll patients at several sites in the United States. It will pave the way for the initiation of a Phase 3 registration study in the first half of 2019.
“We are very pleased that the FDA granted clearance of our Phase 2 trial of lixivaptan for patients with ADPKD” said Lorenzo Pellegrini, CEO of Palladio. “This is a pivotal event for our company as it marks the rebirth of lixivaptan as a clinical stage program for a disease with significant unmet medical need. We would like to take this opportunity to thank our advisors and collaborators for helping us meet this important milestone.”
“We are looking forward to advancing lixivaptan’s development program to provide a meaningfully differentiated treatment option for a broad population of ADPKD patients,” added Frank Condella, Palladio Biosciences’ Director. “We remain committed to working with patients, physicians and the PKD Foundation, the only organization in the U.S. solely dedicated to finding treatments and a cure for Polycystic Kidney Disease, to advance new treatments that improve the lives of patients with kidney disease.”
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.
Palladio Biosciences, Inc.
Linda Hogan, +1 908-294-8728