SAN FRANCISCO, June 13, 2016 /PRNewswire/ -- Symic, a clinical stage biotherapeutics company developing multiple compounds that target and affect the extracellular matrix (ECM), today announced the treatment of the first patient in the MODIFY-OA Clinical Trial (Study to Measure the Safety and Efficacy Outcome after Intra-articular Delivery of SB-061 versus Control in Symptomatic Osteoarthritis Patients) investigating SB-061, a novel and proprietary treatment specifically developed for acute management of osteoarthritis (OA) pain. The 12-week, multicenter, double-blinded trial will randomize approximately 90 patients with mild to moderate OA of the knee.
"SB-061 is delivered directly into the articular synovial space of the affected joint, maximizing the potential therapeutic benefit while reducing off target effects," said Dr. Nathan Bachtell, Chief Medical Officer of Symic. "Unlike systemic, immune-mediated arthritis, osteoarthritis is typically limited to one or a few joints, which enables a targeted therapeutic approach. In general when you can avoid systemic risk by localizing therapy it's a good thing. For example, oral non-steroidal anti-inflammatory drugs, the most widely used treatment for OA, are a leading cause of intestinal bleeding and kidney failure."
SB-061 was designed to be a functional mimic of aggrecan, a macromolecule of the ECM critical to the proper function of healthy cartilage. In patients with OA, aggrecan is known to break down over time, contributing to acute pain and structural decline of the joint.
"SB-061 represents a novel approach to the treatment of osteoarthritis," said Dr. Ivo Valter, a rheumatologist and lead Principal Investigator based in Tallinn, Estonia. "While the specific causative factors may vary between subjects, loss of cartilage integrity plays a role in all patients with osteoarthritis. Directly targeting the cartilage extracellular matrix is a simple yet innovative way to potentially mitigate the symptoms caused by cartilage breakdown." As the Director of Clinical Research at the Center for Clinical and Basic Research in Tallinn, Dr. Valter and his team have been engaged in running clinical trials in OA and other rheumatologic conditions for more than 20 years.
In 2015, Symic entered into a clinical development partnership for SB-061 with Nordic Bioscience (NB), a leader in OA biomarker research and clinical trial management. Consistent with this partnership, NB has played a central role in the design and execution of the MODIFY-OA trial.
Osteoarthritis (OA) is the most common form of arthritis, affecting over 600 million people worldwide. It causes pain and stiffness, as well as chronic degradation of the articular cartilage, joint lining, ligaments and bone. In 2009, over 600,000 total knee replacements (TKRs) were performed in the U.S. alone, at an estimated cost of $9 billion.1 By 2030, the number of TKRs in the U.S. is expected to exceed 3 million, putting the expected annual cost well over $30 billion.
1Cisternas MG, MGC Data Svcs, Murphy L, Croft JB, Helmick CG. Racial Disparities in Total Knee Replacement among Medicare Enrollees — United States, 2000–2006. MMWR 2009; 58(6):134-8
Symic is a clinical stage biotherapeutics company developing novel compounds that target and affect the extracellular matrix (ECM), the non-cellular component of tissue. The ECM plays a critical role in a wide variety of processes involved in acute and chronic indications. Symic's proprietary compounds function like proteoglycans, which are naturally occurring macromolecules that play important structural and regulatory functions in the ECM. Symic currently has two clinical candidates, one in vascular injury and the other in osteoarthritis. In addition, Symic has several preclinical programs in oncology, fibrosis and CNS disorders.
About Nordic Bioscience
Nordic Bioscience is a global drug development organization headquartered in Copenhagen, Denmark. Nordic Bioscience is comprised of three distinct divisions: Biomarkers & Research, Clinical Development and Laboratory Services. These research and development facilities place Nordic Bioscience in a unique position to develop advanced specialist protocols to support clinical studies from Phase 1 to Phase 3 for marketing authorization. Using a data-driven approach, Nordic Bioscience has a long history of applying leading-edge technologies to translational and biomarker science for the evolution of precision medicine, particularly within rheumatology.
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