From Business Wire
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)
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 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.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).
“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.”
About Lixivaptan:
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.
From Market Insider
"We are pleased to advance the RGLS4326 program with the initiation of the MAD study, which will allow us to further characterize the safety and pharmacokinetic profile of RGLS4326 and establish the dose range that we will study in patients with ADPKD," said Timothy Wright, M.D., Chief R&D Officer of Regulus. "RGLS4326 represents a novel approach to treating ADPKD, a genetic disease leading to progressive loss of kidney function and kidney failure in the majority of patients."
This study is designed to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing doses of RGLS4326. The MAD study was initiated based on data from the single ascending dose (SAD) Phase I study, which has completed dose escalation and continues in the planned follow-up phase. Preclinical studies with RGLS4326 have demonstrated a reduction in kidney cyst formation, improved kidney weight/body weight ratio, and decreased cyst cell proliferation in mouse models of ADPKD; and decreased cyst formation in cultured human ADPKD cyst cells in vitro.
About Autosomal Dominant Polycystic Kidney Disease (ADPKD)
ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenetic disorders and a leading genetic cause of end-stage renal disease. The clinical hallmark of this disease is the development of multiple fluid filled cysts primarily in the kidneys and to a lesser extent in the liver and other organs. Excessive kidney tubule derived cyst cell proliferation, a central pathological feature, fuels the expansion of cysts, ultimately causing end-stage renal disease in approximately 50% of ADPKD patients by age 60. Approximately 1 in 1,000 people bear a mutation in either PKD1 or PKD2 genes worldwide.
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