Business Wire

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

Share

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.

Contact information

Linda Hogan
Palladio Biosciences, Inc.
267.609.7550
lhogan@palladiobio.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Northern Data AG Commissions First Data Center in the Netherlands25.11.2020 14:11:00 CETPress release

Northern Data AG (XETRA: NB2, ISIN: DE000A0SMU87), a leading provider of High-Performance Computing (HPC) solutions, is commissioning its latest HPC data center near Maastricht. This new facility will entail one of the largest GPU clusters worldwide and will be the Company's first data center location in the European Union. The Company will begin installing the first hardware for its GPU-based Distributed Computing Cluster from the beginning of December. The GPU cluster is one of Northern Data AG's most significant expansion steps and is expected to be scaled up by the end of Q1/2021 to achieve computing power of 404 Petaflops (FP64). With this level of power, it will be one of the largest GPU clusters of its kind worldwide. The world's most powerful supercomputer, Japan's Fugaku, has a computing capacity of 415 Petaflops. As CEO Aroosh Thillainathan commented: "With the smooth and rapid expansion of our GPU cluster, now including our first European location, we are moving to meet the

LexFinance Announced a Favorable Partial Award in a US$ 28 Billion Arbitration Against Brazil and for the Benefit of Petrobras25.11.2020 14:00:00 CETPress release

LexFinance announced a favorable partial award in a US$ 28 billion arbitration against Brazil and for the benefit of Petrobras. The claim has been filed by a minority shareholder of Petrobras against the Brazilian Government for the economic losses suffered by Petrobras due to corruption practices disclosed in the Car Wash investigation and caused by the abuse of power of the Brazilian Government as controlling shareholder of Petrobras. The partial award recognized the arbitrability of the dispute, that the Brazilian Government is subject to the arbitration clause and the standing of the claimant funded by LexFinance to act on behalf and for the benefit of Petrobras. If the damages are confirmed in the last phase of the arbitration expected to conclude during 2021, the Brazilian Government will have to compensate Petrobras for losses currently estimated at US$ 28 billion. In addition, according to article 246 of the Brazilian Corporate Law, it will have to pay to the claimant funded by

Last and Final Victory for Sisvel Before the German Federal Supreme Court (BGH) In the Sisvel vs Haier Cases25.11.2020 13:29:00 CETPress release

Yesterday the German Federal Supreme Court heard the oral arguments in another patent infringement case between Sisvel and Haier regarding Sisvel’s request for injunctive relief for infringement of cellular standard essential patents (SEPs) it owns. The decision rendered yesterday marks the final decision regarding Haier’s infringement of Sisvel’s European patent EP 1 264 504 (“EP 504”), and the related FRAND defense after a 6 year long legal dispute. Prior to this verdict, the BGH (1) confirmed the German part of Sisvel’s EP 504 valid on April 28, 2020, (2) confirmed the German part of Sisvel’s EP 0 852 885 B1 (“EP 885”) valid on March 10, 2020, and (3) reversed the Düsseldorf Court of Appeal’s 2017 decision that wrongly considered Haier a willing licensee on May 5, 2020. In the motivation of the BGH May 2020 decision, it provided helpful guidance on certain aspects of the FRAND negotiation process (see https://www.sisvel.com/news-events/news/clarifications-on-licensing-of-standard-es

Advanced Technology Research Council Announces ‘ASPIRE’ – to Drive the Creation of Future Transformative Technologies25.11.2020 12:22:00 CETPress release

The newly established Advanced Technology Research Council (ATRC) has today announced its plans to drive the creation of future transformative technologies with the launch of its dedicated technology programme management pillar, ASPIRE. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201125005562/en/ His Excellency Faisal Al Bannai, Secretary-General of Advanced Technology Research Council (Photo: AETOSWire) ASPIRE works in consultation with cross-sector industry stakeholders to frame problem statements that can be solved through research and development. By defining the problem, setting milestones, and monitoring the progress of the projects, ASPIRE facilitates a clear path from ‘lab to market.’ ASPIRE will make impactful decisions related to the selection of research partners and the allocation of funding. It will ensure that its R&D priorities align with Abu Dhabi and the UAE's broader development goals. ASPIRE will also l

Celltrion completes enrolment for global Phase II clinical trial with COVID-19 treatment candidate CT-P5925.11.2020 12:13:00 CETPress release

Celltrion Group today announced enrolment completion of 327 patients with mild-to-moderate symptoms of SARS-CoV-2 infection in the global Phase II clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. Celltrion anticipates submission for emergency use authorisation (EUA) to the Korean Ministry of Food and Drug Safety (MFDS), conditional on results from the global Phase II pivotal trial. The global Phase II clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection. The trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration) and Celltrion is set to obtain the results for global Phase II trial. In addition, Celltrion plans to initiate a global Phase III clinical trial in more than 10 countries in order to obtain more

iHeartMedia and Podimo Partner to Translate and Adapt Widely Popular Podcasts For Listeners Globally25.11.2020 12:00:00 CETPress release

iHeartMedia, the No. 1 audio company in America and the No. 1 podcast publisher globally, and European podcast platform Podimo today announced a strategic partnership to translate and adapt popular podcasts across the globe in different languages, introducing these podcasts to hundreds of millions of new listeners. The partnership will kick off with the widely popular true crime podcast “Forgotten: Women of Juárez” (Olvidadas: Muertes de Juárez) about femicides in Mexico’s most dangerous city in three languages: Spanish, German and Danish. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201125005440/en/ In one of 2020’s most intimate and shocking true crime podcasts, “Forgotten: Women of Juárez,” from iHeartMedia and Unusual Productions, hosts Mónica Ortiz Uribe and Oz Woloshyn investigate theories surrounding the disappearance of hundreds of young women along the Mexican border city of Juárez. Some are tragically found with

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom