FDA Grants IND Clearance to Begin Phase 2 with Lixivaptan in Patients with ADPKD

The US 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).

As announced by Palladio Biosciences, Inc today in a press release, 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).

ADPKD is a genetic disease in which cysts develop in the kidneys.

Lorenzo Pellegrini, CEO of Palladio, shared her excitement over the FDA’s clearance. “We are very pleased that the FDA granted clearance of our Phase 2 trial of lixivaptan for patients with ADPKD. 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.”

Lixivaptan is a potent, selective vasopressin V2 receptor antagonist and is a mechanism of action to slow kidney function decline in adults at risk of rapidly progressing ADPKD. As part of a prior clinical development program for the treatment of hyponatremia, it was previously administered to more than 1,600 subjects across 36 clinical studies.

The ELISA Phase 2 study’s (Evaluation of Lixivaptan In Subjects with ADPKD) primary aim is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of lixivaptan in patients with ADPKD with moderately impaired renal function (CKD3) and relatively preserved kidney function (chronic kidney disease stages CKD1 and CKD2).

Primary measures in the study will include an assessment of endothelial function by peripheral artery tonometry (PAT), NADPH oxidase 4 (NOX4) expression/activity, the mitochondrial DNA copy number, the total kidney volume (TKV), renal blood flow (RBF), and the glomerular filtration rate (GFR).

Enrollment is expected to begin at the end of June 2018. It will be an open-label study, enroll patients at several sites in the United States, and make way for the initiation of a Phase 3 registration study in the first half of 2019.

Frank Condella, Palladio Biosciences’ Director, feels cnofident about lixivaptan’s development. “We are looking forward to advancing lixivaptan’s development program to provide a meaningfully differentiated treatment option for a broad population of ADPKD patients. 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.”

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