SAN FRANCISCO, Nov. 10, 2016 /PRNewswire/ -- Symic Bio, a clinical stage biopharmaceutical company developing a new category of therapeutics focused on extracellular matrix biology, announced today the completion of enrollment for its Phase 1/2a MODIFY-OA clinical trial of SB-061 in the treatment of osteoarthritis of the knee. Top-line results from the trial are expected to be announced in the first half of 2017.
The trial is designed to assess the safety and efficacy of SB-061 and includes a primary efficacy endpoint of Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score as measured over the duration of the trial. Secondary endpoints include measurements of biomarkers associated with the progression of disease. The 12-week, multicenter, double-blinded trial involves 147 patients randomized to two treatment groups. Patients receive two intra-articular injections of either SB-061 or placebo and are observed over three months.
SB-061 is designed to be a functional mimic of aggrecan, a macromolecule of the extracellular matrix critical to the proper function of healthy cartilage. In patients with osteoarthritis, aggrecan is known to degrade over time, contributing to acute pain and structural decline of the joint.
Symic Bio entered a non-commercial partnership with Nordic Bioscience, a leader in osteoarthritis biomarker research and clinical trial management, for the clinical development of SB-061. Nordic Bioscience has played a central role in the design and execution of the MODIFY-OA trial, which is being conducted at four sites in three European countries. The first patient was enrolled in June 2016 and enrollment was completed within four months.
"We are very pleased with the scientific and operational expertise of Nordic Bioscience in helping us efficiently reach this point in the clinical development of SB-061, a novel intraarticular therapy directed at the underlying pathophysiology of osteoarthritis," said Ken Horne, Chief Executive Officer of Symic Bio. "The MODIFY-OA trial will not only help determine the effects of SB-061 on pain and function but may also show signs of its capacity to modify the course of disease. We are looking forward to reporting results from the MODIFY-OA trial in the first half of 2017."
"The partnership with Symic Bio has proven to be an excellent match with our expertise in osteoarthritis clinical trial design and execution, as well as with our legacy in extracellular matrix biomarker research. Our setup is designed for operational efficiency and fast recruitment as demonstrated in this study," said Jeppe Ragnar Andersen, Chief Executive Officer of Nordic Bioscience Clinical Development A/S, a part of the Nordic Bioscience Group.
Osteoarthritis 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.
1 Cisternas 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
About Symic Bio
Symic Bio is a clinical stage biopharmaceutical company developing a new category of therapeutics focused on extracellular matrix biology. These therapeutics, with potential applications in a wide variety of disease states, are inspired by naturally occurring macromolecules of the extracellular matrix. Symic Bio currently has two clinical candidates, one for the treatment of critical limb ischemia (SB-030) and one directed at disease-modification in the treatment of osteoarthritis (SB-061). In addition, Symic Bio is investigating applications in the areas of fibrosis, oncology and diseases of the central nervous system.
About Nordic Bioscience
Nordic Bioscience is a global drug development organization headquartered in Copenhagen, Denmark. Nordic Bioscience engages in clinical research and innovative biomarker research focusing on connective tissue diseases. The capabilities and experience with research and development place Nordic Bioscience in a unique position to develop advanced specialized protocols to conduct innovative clinical studies from Phase 1 to Phase 3. Using a data-driven approach, Nordic Bioscience has a long history of applying novel technologies in translational and biomarker science promoting precision medicine, particularly within rheumatology.
Lisa Burns or Bill Slattery, Jr.
Burns McClellan, Inc.
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SOURCE Symic Bio