Palladio Biosciences has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to begin the ELISA Phase II clinical trial of lixivaptan capsules to treat patients with autosomal dominant polycystic kidney disease (ADPKD).
The Evaluation of Lixivaptan In Subjects with ADPKD (ELISA) Phase II trial is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of several doses of lixivaptan in ADPKD patients with relatively preserved kidney function and moderately impaired renal function.
The open-label trial aims to start enrolling patients at the end of June this year at multiple sites across the US.
Results from the trial are expected to help Palladio conduct a Phase III registration study in the first half of next year.
Palladio Biosciences director Frank Condella said: “We remain committed to working with patients, physicians and the PKD Foundation, the only organization in the US 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.”
ADPKD is the most common type of polycystic kidney disease (PKD), which is an inherited genetic disease that reportedly affects thousands of people in the US and millions worldwide.
The disease leads to uncontrolled growth of fluid-filled cysts in the kidney, which can each grow to be as large as a football. Symptoms of the disease often include kidney infections and chronic pain.
Palladio’s Lixivaptan is a potent, selective vasopressin V2 receptor antagonist, a mechanism of action that can slow kidney function decline in adults who are at risk of rapidly progressing ADPKD.