Enrollment Completed in Symic Bio's SHIELD Trial of SB-030 for PAD Interventions
February 27, 2017—Symic Bio recently announced completion of enrollment for the SHIELD clinical trial that is evaluating the safety and efficacy of SB-030, which is a locally administered single-use therapeutic for the reduction of restenosis following angioplasty in peripheral artery disease (PAD). SB-030 is designed to reduce platelet binding and activation to the injured vessel wall caused by vascular procedures and is intended to reduce inflammation and thus decreased restenosis caused by neointimal hyperplasia.
The proof-of-concept phase 1/2a SHIELD (Study in Humans to Investigate the Efficacy and Safety of Luminal SB-030 Delivery in PAD) trial is a parallel, blinded, randomized (2:1) clinical trial that involves multiple sites in Australia and New Zealand. The trial enrolled 67 patients with symptomatic PAD. The company anticipates top-line results from the study in the fourth quarter of 2017.
The study will compare the safety and efficacy of balloon angioplasty with or without the administration of SB-030 in patients undergoing angioplasty to address reduced blood flow (occlusions) within the femoral artery. The trial includes a primary efficacy measurement of late lumen loss at 6 months, a standard measure of restenosis following vascular injury, and will also evaluate other clinically relevant outcomes such as target lesion revascularization.
In the company's announcement, Michael Conte, MD, commented, "Completion of enrollment of the SHIELD trial is very encouraging. If successful, positive proof-of-concept results will pave the way for additional studies of SB-030 in endovascular and surgical indications.” Dr. Conte is Professor and Chief of the Division of Vascular and Endovascular Surgery at the University of California, San Francisco (UCSF), and Co-Director of the UCSF Center for Limb Preservation in San Francisco, California.