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.
Palladio Biosciences, Inc.
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Kalray Joins MLCommons as Founding Member3.12.2020 20:30:00 EET | Press release
Kalray (Euronext Growth Paris: FR0010722819 – ALKAL) (Paris:ALKAL), a pioneer in processors for new intelligent systems, today announced it has joined MLCommons as founding member. MLCommons is a not for profit, engineering consortium founded by 30+ global technology and academic leaders in AI and Machine Learning to accelerate machine learning innovation and broaden access to this critical technology for the public good. Initially formed as MLPerf, MLCommons boasts a founding board that includes representatives from Alibaba, Facebook AI, Google, Intel, NVIDIA and Professor Vijay Janapa Reddi of Harvard University with the objective to deliver industry-wide benchmarks, best practices and datasets to speed computer vision, natural language processing, and speech recognition development for all. “MLCommons has a clear mission - accelerate Machine Learning innovation to ‘raise all boats’ and increase its positive impact on society” said Peter Mattson, President of MLCommons. “We are excit
Hyperloop Transportation Technologies Accelerates with 100 Engineers from World Leading Firm Altran3.12.2020 19:40:00 EET | Press release
Hyperloop Transportation Technologies (HyperloopTT) announced today an agreement with world-leading engineering and R&D services provider Altran, part of the Capgemini Group. The agreement includes one hundred Altran engineers to accelerate the development of commercialized passenger hyperloop systems at the HyperloopTT facility in Toulouse, France, the Aerospace Valley of Europe. HyperloopTT’s European R&D Center is the home of the world’s only full-scale hyperloop system, which has been undergoing testing and optimization since 2019. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201203005174/en/ HyperloopTT's full-scale test system in Toulouse, France (Photo: Business Wire) The agreement advances HyperloopTT’s capabilities in a lean way, negotiated within HyperloopTT’s hybrid collaborative framework. The announcement comes after recent commitments from both the European Union and the United States, emphasizing the develop
Dan Bilzerian Joins Team GGPoker & Celebrates With $100,000 Birthday Freeroll3.12.2020 19:00:00 EET | Press release
GGPoker today announces that Dan Bilzerian has joined Team GGPoker as a brand ambassador. One of the world’s most recognizable poker players and social media influencers, with over 32 million followers on Instagram, “Blitz” will represent GGPoker live and online. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201203005724/en/ Dan Bilzerian, GGPoker's newest brand ambassador. (Photo: Business Wire) To celebrate the news, the online poker room will host a special 40th birthday party for the ‘King of Instagram’ on December 7 in the form of a $100,000 Birthday Freeroll poker tournament. This free-to-enter poker game is open to all new GGPoker players that sign up using code BLITZ40 and deposit $10 or more. What : Dan’s $100,000 Birthday Freeroll When : Monday, December 7 at 17:00 UTC How To Enter : Sign up using code BLITZ40, deposit at least $10 and use your ticket to register for the freeroll tournament Tournament Prize Pool :
Odense Investor Summit Introduces Investors to 15 Promising Robot Companies in Europe’s Robot Capital3.12.2020 18:47:00 EET | Press release
In just five years, robotic start-ups based in Odense, Denmark – the robot capital of Europe – have attracted more than 976 million USD. This year, the local Danish entrepreneurs will be joined by companies from the RobotUnion Super Stars; finalists from the pan-European robot acceleration program. The event is being sponsored by Vækstfonden, the Danish State’s investment fund, with the objective of making matches between leading Danish entrepreneurs seeking capital backing, and top international investors on the hunt for the next “golden goose” in the world of robotics. On December 9th, a carefully selected field of robot enterprises seeking capital will be presenting their ground-breaking automation solutions for a broad spectrum of industries at this year’s Odense Investor Summit. The 2020 summit is being held as a virtual event to involve participants from all parts of Europe and provide access to a new audience while still observing the prevailing COVID-19 restrictions. In additio
IEEE Launches 802.3™ Beyond 400Gb/s Ethernet Study Group to Define Next High Speed Threshold for Ethernet Data Rate3.12.2020 18:30:00 EET | Press release
IEEE, the world's largest technical professional organization dedicated to advancing technology for humanity, and IEEE Standards Association (IEEE SA) today announced the formation of a study group within the IEEE 802.3™ Ethernet Working Group. With bandwidth demand growing across all areas of Ethernet connectivity globally, the IEEE 802.3 Beyond 400Gb/s Ethernet Study Group will explore initiating a new IEEE project that would standardize capabilities exceeding today’s maximum data rate of 400 Gigabit per second (Gb/s) for IEEE 802.3, IEEE Standard for Ethernet. The publicly available IEEE 802.3™ Ethernet Bandwidth Assessment (BWA) report, released in April 2020, showed that trends around traffic drivers such as video, hyperscale data centers, 5G and deployment of IEEE 802.11™ “Wi-Fi®” all point toward an ongoing bandwidth explosion for Ethernet networks around the world in the years ahead. Undeniably, simultaneous trends point toward more users, faster access speeds, more services, m
Starcity Acquires Ollie, Accelerating Its Growth as a Vertically Integrated Global Coliving Company3.12.2020 18:00:00 EET | Press release
Starcity is acquiring Ollie’s key assets, including its technology, intellectual property, and business agreements in major cities, which when combined with Starcity, will create one of the largest coliving developers and operators globally. Ollie is widely recognized as a pioneer in the coliving asset class and has partnered with institutional owners to deliver much needed affordability and community to top tier cities such as New York, Los Angeles, the San Francisco Bay Area, and Boston. Additionally, Ollie has built a proprietary technology suite of services to foster community engagement, deliver hospitality services and provide roommate matching within its communities. Following the transaction, Ollie’s key personnel will join Starcity to create a leading organization with the mission to make great cities accessible to everyone. “We are thrilled to bring on board such a high caliber team with institutional grade communities. Most importantly, we are humbled to expand our inviting,
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