Selecta Biosciences Initiates Head-to-Head Clinical Trial (COMPARE) of SEL-212 vs. KRYSTEXXA® in Patients with Chronic Refractory Gout and Strengthens Management Team
- Category: Proteins and Peptides
- Published on Saturday, 30 March 2019 10:40
- Hits: 707
-First patient enrolled in COMPARE trial evaluating efficacy and safety of SEL-212 v. KRYSTEXXA® in patients with chronic refractory gout
-Strengthened management and clinical teams with the appointments of Elona Kogan, J.D. as General Counsel & Corporate Secretary and Horacio Plotkin, MD, FAAP as Head of Clinical Development
WATERTOWN, MA, USA I March 29, 2019 I Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, today announced the initiation of a six month head-to-head clinical trial (COMPARE), designed to evaluate superiority of its lead product candidate, SEL-212 (ImmTOR + Pegadricase), compared to KRYSTEXXA, the current U.S. Food and Drug Administration (FDA) - approved uricase therapy in adult patients with chronic refractory gout. Additionally, the company has also strengthened its management and clinical development teams with the appointments of Elona Kogan, J.D. as General Counsel and Corporate Secretary, and Horacio Plotkin, MD, FAAP as Head of Clinical Development.
“We are excited about the opportunity to demonstrate the superiority of SEL-212 compared to the current FDA-approved uricase therapy, as we continue to believe that our product candidate has the potential to fulfill several unmet needs in chronic refractory gout patients, including sustained serum uric acid reduction, reduced painful flares and once monthly dosing. We expect to report interim six-month data in the fourth quarter of 2019,” said Dr. Carsten Brunn, President and CEO of Selecta Biosciences. “Additionally, we are pleased to welcome both Elona and Horacio to the Selecta team. Their extensive experience in the biopharmaceutical industry will be instrumental as we continue to develop our ImmTOR platform for rare and serious diseases that require new treatment options.”
“I am delighted to join Selecta and to work with such driven and accomplished colleagues. This is a pivotal time for the company as we kick off the COMPARE trial with the aim of making significant therapeutic advances in chronic refractory gout and continue advancing Selecta’s promising ImmTOR gene therapy platform,” said Ms. Kogan. “Physicians and patients are relying on the delivery of novel treatments to improve patients’ lives and I am eager to contribute to this mission.”
The COMPARE trial is expected to enroll between 100 and 150 patients and is designed to compare the efficacy and safety of SEL-212 to Krystexxa in adult patients with chronic refractory gout. The primary endpoint is expected to be the maintenance of serum uric acid (sUA) levels of <6mg/dL at six months. An interim six-month data readout is projected in the fourth quarter of 2019 with a full statistical superiority data analysis readout expected in the first quarter of 2020. The results of the COMPARE trial are expected to inform the design of the planned Phase 3 clinical trial of SEL-212, which the company plans to initiate in the fourth quarter of 2019.
Key Management Appointments:
Elona Kogan, J.D. joins Selecta as General Counsel and Corporate Secretary after most recently serving as General Counsel and head of Government Relations at ARIAD Pharmaceuticals, Inc., a rare disease oncology company, where she was a key executive through the acquisition of the company by Takeda Pharmaceuticals Company Limited. Prior to joining ARIAD, Ms. Kogan led the legal and government affairs functions of a publicly traded pharmaceutical company, dedicated to developing treatments for central nervous system disorders, where she played a central role in the strategic acquisition of the company by Otsuka Pharmaceutical Co. Ltd. Prior roles included positions of increasing responsibility at King Pharmaceuticals, Inc., Bristol-Myers Squibb, and Bergen Brunswig Corporation. Ms. Kogan is a graduate of the SCALE program at Southwestern University School of Law. Ms. Kogan graduated cum laude from Columbia University, Barnard College, with a degree in economics. Ms. Kogan is also a member of the board of directors of a biotechnology company and serves as the Chairperson of the Compensation Committee, and a member of the Audit Committee.
Horacio Plotkin, MD, FAAP brings 20 years of clinical pediatric experience and 12 years in biotech to Selecta Biosciences as the new Head of Clinical Development. Most recently, he was Head of Clinical Development, Rare Diseases at Moderna Therapeutics. Dr. Plotkin is also an Adjunct Associate Professor of Pediatrics and Orthopedic Surgery at the University of Nebraska School of Medicine and is a member of the scientific advisory board for several rare disease patient advocacy organizations and a member of the Advances in Therapeutics and Technology section at the American Academy of Pediatrics. He has authored eight chapters in medical textbooks and more than 50 scientific papers and presented more than 70 abstracts in national and international scientific meetings. Dr. Plotkin has previously held positions at Genzyme, Enobia, Alexion, Retrophin, Shire and PPD, and from 2002 to 2007 he was the founder and medical director of the Pediatric Bone Diseases program within the Metabolic Diseases Department at University of Nebraska. Dr. Plotkin earned his medical degree from the University of Buenos Aires School of Medicine. He performed a pediatrics residency, followed by fellowships in pediatric endocrinology at the J. P. Garrahan Pediatric Hospital, metabolic bone diseases at the Metabolic Research Institute, endocrinology at the Yale University School of Medicine and pediatric metabolic bone diseases at the Shriners Hospital for Children and McGill University.
About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance technology (ImmTOR) platform. Selecta plans to combine ImmTOR with a range of biologic therapies for rare and serious diseases that require new treatment options due to high immunogenicity. The company’s current proprietary pipeline includes ImmTOR-powered therapeutic enzyme and gene therapy product candidates. SEL-212, the company’s lead product candidate, is being developed to treat chronic refractory gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s proprietary gene therapy product candidates are in preclinical development for certain rare inborn errors of metabolism and incorporate ImmTOR with the goal of addressing barriers to repeat administration. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com.
SOURCE: Selecta Biosciences