SAN FRANCISCO, Feb. 24, 2017 /PRNewswire/ -- Symic Bio, a biopharmaceutical company focused on matrix biology that is developing a new category of therapeutics, announced today the completion of enrollment for the SHIELD clinical trial of SB-030 in peripheral artery disease. The trial will evaluate the safety and efficacy of SB-030, a locally administered single-use therapeutic, in the reduction of restenosis following angioplasty.
"We're pleased to have reached this critical development milestone for SB-030," said Nathan Bachtell, M.D., Chief Medical Officer of Symic Bio. "SB-030 represents a pioneering matrix biology approach for addressing restenosis after vascular interventions, a prevalent and costly complication that is inadequately addressed by current therapies. We look forward to top-line results from this proof-of-concept study in the fourth quarter of 2017."
"Completion of enrollment of the SHIELD trial is very encouraging," stated Michael Conte, M.D., Professor and Chief of the Division of Vascular & Endovascular Surgery at the University of California, San Francisco (UCSF), and Co-Director of the UCSF Center for Limb Preservation. "If successful, positive proof-of-concept results will pave the way for additional studies of SB-030 in endovascular and surgical indications."
About the SHIELD trial
The proof-of-concept Phase 1/2a SHIELD (Study in Humans to Investigate the Efficacy and Safety of Luminal SB?030 Delivery in peripheral artery disease) 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 peripheral artery disease. It 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.
About SB-030
Symic Bio is developing SB-030 (previously SBCV-030) as a locally administered single-use treatment for use during cardiovascular procedures. 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 due to scar tissue (neointimal hyperplasia). Restenosis is a leading cause of occlusions following peripheral vascular procedures and can lead to severe complications such as critical limb ischemia and amputation.
About Symic Bio
Symic Bio is a biopharmaceutical company focused on matrix biology that is developing a new category of therapeutics. 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 will initially target 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.
Investor ContactsGitanjali Jain OgawaThe Trout Group(646) [email protected]
Media ContactsDavid Schull or Rich AllanRusso Partners, LLC(212) 845-4271(212) [email protected] [email protected]
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"We're pleased to have reached this critical development milestone for SB-030," said Nathan Bachtell, M.D., Chief Medical Officer of Symic Bio. "SB-030 represents a pioneering matrix biology approach for addressing restenosis after vascular interventions, a prevalent and costly complication that is inadequately addressed by current therapies. We look forward to top-line results from this proof-of-concept study in the fourth quarter of 2017."
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"Completion of enrollment of the SHIELD trial is very encouraging," stated Michael Conte, M.D., Professor and Chief of the Division of Vascular & Endovascular Surgery at the University of California, San Francisco (UCSF), and Co-Director of the UCSF Center for Limb Preservation. "If successful, positive proof-of-concept results will pave the way for additional studies of SB-030 in endovascular and surgical indications."
About the SHIELD trial
The proof-of-concept Phase 1/2a SHIELD (Study in Humans to Investigate the Efficacy and Safety of Luminal SB?030 Delivery in peripheral artery disease) 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 peripheral artery disease. It 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.
About SB-030
Symic Bio is developing SB-030 (previously SBCV-030) as a locally administered single-use treatment for use during cardiovascular procedures. 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 due to scar tissue (neointimal hyperplasia). Restenosis is a leading cause of occlusions following peripheral vascular procedures and can lead to severe complications such as critical limb ischemia and amputation.
About Symic Bio
Symic Bio is a biopharmaceutical company focused on matrix biology that is developing a new category of therapeutics. 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 will initially target 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.
Investor ContactsGitanjali Jain OgawaThe Trout Group(646) [email protected]
Media ContactsDavid Schull or Rich AllanRusso Partners, LLC(212) 845-4271(212) [email protected] [email protected]
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SOURCE Symic Bio
