Palladio Biosciences Announces First Patient Dosed With Lixivaptan in The ALERT Study, a Phase 3 Study of ADPKD Patients Previously Discontinued From Treatment With Tolvaptan Due to Liver Toxicity
Palladio Biosciences, Inc. (Palladio), a privately-owned, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney, today announced that the first patient has been dosed with lixivaptan, a novel vasopressin V2 antagonist, in The ALERT Study.
The ALERT Study, designed to assess the safety of lixivaptan in autosomal dominant polycystic kidney disease (ADPKD) patients who previously discontinued therapy with tolvaptan due to liver toxicity, is currently recruiting patients in the United States. Tolvaptan is the only drug currently approved by FDA to treat the more than 140,000 patients diagnosed with ADPKD in the United States.
The study is currently enrolling ADPKD patients between the ages of 18 and 65 who have been permanently discontinued from tolvaptan therapy due to liver chemistry abnormalities or other signs of liver toxicity. The primary objective is to determine the liver safety of lixivaptan in these patients, who will be treated with lixivaptan for up to 58 weeks.
“This study will continue to build on the safety profile of lixivaptan. A previous in silico modeling study using DILIsym®, a quantitative systems toxicology model of drug-induced liver injury (DILI), found that lixivaptan had a more favorable profile compared to tolvaptan with respect to the toxicity mechanisms represented in DILIsym and therefore may have a lower risk of hepatotoxicity in a clinical setting,” said Lorenzo Pellegrini, PhD, Founder and Chief Operating Officer of Palladio Biosciences. “This study will add to the safety data from the PA-103 clinical study recently presented at the American Society of Nephrology meetings, in which lixivaptan was administered safely for 14 months to a patient who also had previously discontinued tolvaptan due to elevated liver chemistry tests, an indicator of liver toxicity.”
“DILI is a significant concern for patients and physicians considering pharmacological treatment for ADPKD. The ALERT Study will help address such concerns by testing lixivaptan in ADPKD patients who no longer are able to be treated with tolvaptan,” said Neil H Shusterman, MD, Chief Medical Officer of Palladio Biosciences. “We are also advancing preparations for our pivotal trial, a global Phase 3 registration study expected to enroll approximately 1,200 ADPKD patients.”
“We would like to thank the ADPKD community, including the patients who participate in clinical trials, the PKD Foundation, as well as the physicians and other healthcare providers, for their continuing support of clinical trials and the work needed to bring new therapies to patients,” said Alex Martin, Chief Executive Officer of Palladio Biosciences.
About Palladio Biosciences, Inc.
Palladio Biosciences is a privately-held, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney. Palladio is developing its lead drug, lixivaptan, for autosomal dominant polycystic kidney disease (ADPKD), an orphan kidney disease for which there are limited treatment options. 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 has successfully completed a Phase 2 clinical trial, The ELiSA Study, in patients with ADPKD, and has also been successfully administered to a patient who had previously been unable to take tolvaptan due to liver enzyme increases under an expanded access program. Lixivaptan is for investigational use only. For more information about these studies as well as additional details about The ALERT Study, please visit our website at Palladio.
Polycystic Kidney Disease (PKD) Key Facts and Figures
PKD is an inherited genetic disease that affects up to 600,000 people in the United States and millions globally. It is estimated that approximately 140,000 people in the United States have been diagnosed with ADPKD, 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 pain. The continued enlargement of cysts and replacement of normal kidney tissue causes irreversible loss of renal function. Every year there are approximately 2,500 new PKD patients in the United States who require dialysis or a kidney transplant, making PKD the fourth leading cause of kidney failure. There is no cure for PKD.
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