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03-Jan-2019

Palladio Biosciences Appoints Neil H. Shusterman, M.D., as Chief Medical Officer (CMO)

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 that Dr. Neil H. Shusterman has assumed the role of Chief Medical Officer (CMO) effective immediately. Dr. Shusterman previously served as medical adviser to Palladio Biosciences.

“I am delighted that Dr. Shusterman has joined Palladio as our CMO,” said Lorenzo Pellegrini, CEO of Palladio. “As an accomplished nephrologist with an impressive record of successful drug development in both large pharma and biotech, Neil’s key priorities will be setting strategy for and execution of development programs from clinical trials through regulatory filings. His addition to the Palladio team will benefit the lixivaptan development program, including ELiSA, our Phase 2 clinical development trial, as well as the Phase 3 global development plan.”

“Joining the Palladio Bioscience team is an exciting opportunity to advance the treatment of autosomal dominant polycystic kidney disease (ADPKD) and potentially other renal disorders. This represents an area of unmet need as new therapeutic options for patients with kidney disease have not received as much attention as those in other therapeutic areas. With my experience in nephrology and drug development, I believe I can help advance the goals of the company,” said Neil H. Shusterman, M.D., Chief Medical Officer of Palladio Biosciences.

Dr. Shusterman is board certified in internal medicine and nephrology. He has more than 29 years of industry experience, holding senior leadership positions in large, medium, and small companies. He contributed to the development or approval of numerous drugs across multiple therapeutic areas, including argatroban injection, Aveed®, Bystolic®, Combunox™, Coreg, Corlopam™, Savella®, Teveten®, Vraylar™, and Xiaflex®.

Prior to joining Palladio Biosciences, Neil worked at Endo Pharmaceuticals Inc., where he was the Chief Medical Officer with responsibility for 5 departments – Clinical Development and Operations, Medical Affairs, Drug Safety, Biometrics, and Scientific Communications; at Forest Laboratories, Inc., where he was Senior Vice President of Clinical Development at Forest Research Institute with responsibilities for Phase II – IV clinical development for five therapeutic areas – Cardiovascular, Pulmonary, Gastrointestinal/Metabolism, Psychiatry, and Neurology; and at SmithKline Beecham (subsequently GlaxoSmithKline), where he advanced to Vice President, Cardiovascular Therapeutic Area, North American Medical Affairs, Research and Development with worldwide responsibilities for all Phase II – IV cardiovascular drug development. During his tenure at SmithKline Beecham, Neil led the worldwide pivotal efficacy studies and regulatory filing for Coreg (carvedilol), the first beta-blocker approved for the treatment of chronic heart failure (CHF). That approval led to a paradigm-shift in the treatment of CHF, resulting in reduced morbidity and mortality in this devastating condition. In addition, Neil led several large cardiovascular morbidity and mortality studies that recruited 20,000 patients combined at hundreds of sites on 3 continents.

Before joining the pharmaceutical industry, Neil practiced nephrology at the University of Pennsylvania in Philadelphia, PA where he was Assistant Professor of Medicine and directed a large outpatient dialysis program. Neil has published and presented widely on topics in renal medicine, cardiovascular therapeutics, and drug development. He earned his undergraduate degree from the Pennsylvania State University and his M.D. from Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA.

About Lixivaptan:

Lixivaptan was granted Investigational New Drug (IND) clearance to proceed with a Phase 2 clinical trial of lixivaptan capsules in patients with ADPKD, the ELiSA trial, 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.

To learn more about the ELiSA trial, which is currently enrolling subjects, 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/

Please note that lixivaptan is for investigational use only.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190103005050/en/

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Last Updated: 03-Jan-2019