SAN FRANCISCO, May 18, 2017 /PRNewswire/ -- Symic Bio, a biopharmaceutical company developing novel matrix regulator therapeutics, today announced topline results from the Phase 1/2a MODIFY-OA trial of SB-061, an intra-articular treatment for osteoarthritis of the knee. SB-061 was shown to be safe and very well-tolerated with no drug-related serious adverse events and a very low rate of local adverse events (4.1 percent). Treatment with SB-061 resulted in an approximately 60 percent peak improvement in the Western Ontario and McMaster Universities Arthritis Index pain while walking score (WOMAC A1), the primary efficacy measure, although this measurement did not reach statistical significance relative to the saline control treatment group. In addition, positive trends in synovial fluid biomarker measures (e.g. reduction in inflammatory cytokine TNF-alpha) were observed in the SB-061 treatment group that reinforce the SB-061 intended mechanism of action in human studies for the first time.
"The overall results from MODIFY-OA support the safety and mechanism of this new approach to targeting the underlying pathology of osteoarthritis," commented Ken Horne, Chief Executive Officer of Symic Bio. "SB-061 represents a distinctively novel therapeutic approach with the aim of both improving symptoms and modifying disease progression. The encouraging safety profile, degree of pain improvement and synovial fluid biomarker trends all support ongoing clinical development. We anticipate starting another Phase 2 trial this year."
SB-061 is designed to be a functional mimic of aggrecan, a natural macromolecule of the extracellular matrix critical to the health of cartilage tissue. The first-in-human MODIFY-OA trial was designed to explore trends in safety and efficacy parameters of SB-061.
About the MODIFY-OA trial
The 12-week, multicenter, double-blinded MODIFY-OA trial of SB-061 for the treatment of osteoarthritis of the knee randomized 147 patients to two treatment groups. The trial is designed to assess the safety and efficacy of SB-061 and includes a primary efficacy endpoint of change from baseline in Western Ontario and McMaster Universities Arthritis Index walking pain score (WOMAC A1) pain score as measured over the duration of the trial. Secondary endpoints included the other WOMAC composite endpoints and measurements of biomarkers associated with the SB-061 mechanism of action and osteoarthritis disease progression. Patients received two intra-articular injections of either SB-061 or placebo, one on day one and the second on day eight, and were observed over three months.
About Symic Bio
Symic Bio is a biopharmaceutical company developing novel matrix regulators, a new category of therapeutics focused on matrix biology. These therapeutics, with potential applications in a wide variety of disease states, are inspired by naturally occurring macromolecules that play key regulatory roles within the extracellular matrix. Symic Bio currently has two clinical candidates: SB-030, which is targeting the prevention of peripheral vein graft failure, and SB-061, directed at disease modification and pain management in the treatment of osteoarthritis. In addition, Symic Bio is investigating applications in the areas of fibrosis, oncology and diseases of the central nervous system. For additional information please visit the company's website at www.symic.bio, LinkedIn page at www.linkedin.com/company/symic-bio or follow on Twitter at www.twitter.com/symicbio.
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SOURCE Symic Biomedical