Symic Biomedical, a clinical-stage biotherapeutics platform company developing compounds that target the extracellular matrix (ECM), today announced the treatment of the first patient in its Phase 1/2 clinical Study in Humans to Investigate the Efficacy and Safety of Luminal SB-030 Delivery in Peripheral Artery Disease (SHIELD Trial). The study will evaluate the safety and efficacy of SB-030 (previously SBCV-030), a locally applied, single-use treatment for the reduction of neointimal hyperplasia resulting from the vascular injury following percutaneous transluminal angioplasty (PTA).
This multicenter, parallel, blinded, randomized clinical trial is designed to compare the safety and efficacy of balloon angioplasty with or without the addition of SB-030 in peripheral artery disease (PAD) patients undergoing procedures for stenosis or occlusion within the superficial femoral artery (SFA). The trial will enroll approximately 66 patients at multiple sites in Australia and New Zealand.
“SB-030 is delivered locally at the site of injury during the end of the interventional procedure without a significant change to the standard-of-care,” said Ken Horne, Chief Executive Officer of Symic Biomedical. “During surgical or interventional vascular procedures, the vulnerable lining of the vessel is injured, which leads to a local cascade of unwanted events, from initial inflammation to delayed neointimal hyperplasia (vessel scarring). SB-030 is designed specifically to prevent this cascade, and as a result, to reduce the risk of vessel restenosis caused by neointimal hyperplasia.”
Dr. Andrew Holden, director of interventional services at Auckland City Hospital and Associate Professor of Radiology at Auckland University School of Medicine, New Zealand, said, “SB-030 represents a truly novel approach in the field of vascular intervention, particularly for patients being treated for PAD. We are excited to be a lead center in the evaluation of this treatment as part of the SHIELD Trial.”
Symic is developing SB-030 (previously SBCV-030) as a locally applied, single-use treatment during vascular interventions. Engineered to mimic the healing and protective effects of naturally occurring proteoglycans, SB-030 reduces acute ECM-mediated inflammation and thus reduces the leading cause of restenosis, neointimal hyperplasia.
About Symic Biomedical
Symic Biomedical is a clinical-stage biotherapeutics platform company developing a pipeline of products targeting the extracellular matrix (ECM). Symic’s proprietary compounds are inspired by proteoglycans, important structural and regulatory macromolecules native to the ECM, which is the non-cellular component of tissues that is critical for healthy tissue function. Components of the ECM, particularly proteoglycans, play a critical role in healing following injury and in chronic diseases. SB-030 is Symic’s lead compound under evaluation in the Phase 1/2 clinical study for vascular endothelial injury.
Symic Biomedical is based in San Francisco. For additional information, please visit the company’s website at http://www.symic.bio.