Research & Development
FDA Grants Palladio Biosciences IND Clearance for Phase 2 Clinical Trial of Lixivaptan in Patients with Autosomal Dominant PKD
14 May 2018 - - The US Food and Drug Administration has granted Newtown, Pennsylvania-based biopharmaceutical company Palladio Biosciences, Inc. investigational new drug clearance to proceed with a Phase 2 clinical trial of lixivaptan capsules in patients with autosomal dominant polycystic kidney disease (ADPKD), the company said.
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.
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 US.
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 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.
Privately held Palladio Biosciences is a clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney.
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