–ELiSA Study designed to evaluate the safety and activity of multiple doses of lixivaptan in patients with ADPKD–
December 18, 2018 09:15 AM Eastern Standard Time
NEWTOWN, Pa.–(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 the dosing of the first patients with lixivaptan in ELiSA, a phase 2 clinical study in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
The ELiSA study (Evaluation of Lixivaptan in Subjects with ADPKD), which is being conducted at several clinical sites in the United States, will look at how well two different doses of lixivaptan work in preserving kidney function. It will also look at how well adult subjects with ADPKD tolerate the study drug, which will be given by mouth for 7 days. The study is enrolling male or female ADPKD patients between 18 and 60 years of age and estimated Glomerular Filtration Rate (eGFR) greater than 30 mL/min/1.73m2. Completion of the ELiSA study will pave the way for the initiation of a Phase 3 registration study in 2019.
“Dosing the first ADPKD patients with lixivaptan is a major milestone for Palladio Biosciences,” said Lorenzo Pellegrini, CEO of Palladio. “The ELiSA Study is a key component of our clinical development program and will be used to inform the design of our upcoming pivotal Phase 3 study. We believe that lixivaptan has the potential to meet some of the many unmet medical needs of ADPKD patients.”
David Baron, Chief Scientific Officer of the PKD Foundation, said, “PKD is part of America’s under-recognized kidney disease epidemic. We at the PKD Foundation continue to support the development of new drug therapies for patients with PKD, in part by increasing awareness of PKD clinical studies. We look forward to seeing results of the ELiSA trial and the continued development of lixivaptan for ADPKD.”
To learn more about the trial, visit the Clinicaltrials.gov website at https://www.clinicaltrials.gov/ct2/show/study/NCT03487913. Additional details can also be found at http://palladiobio.com/clinical-trials/ and https://pkdcure.org/clinical-study/elisa-evaluation-lixivaptan-subjects-adpkd/.
Lixivaptan was granted Investigational New Drug (IND) clearance to proceed with a Phase 2 clinical trial of lixivaptan capsules in patients with ADPKD in the first half of 2018. It had previously received 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.
About the PKD Foundation:
The PKD Foundation is the only organization in the U.S. solely dedicated to finding treatments and a cure for PKD to improve the lives of those it affects.
Our vision is to #endPKD. To learn more about PKD, please visit the PKD Foundation website: https://pkdcure.org/resources/category/advocacy/#
Please note that lixivaptan is for investigational use only.
ContactsPalladio Biosciences, Inc.
Linda Hogan, +1 908-294-8728