Symic Bio, a biopharmaceutical company based in California specializing in matrix biology, is set to commence a phase 1/2a clinical study, dubbed SHIELD, for its peripheral artery disease drug, SB-030. The study is scheduled across multiple sites in Australia and New Zealand, enlisting 67 patients with symptomatic peripheral artery disease.

Trial Focus and Methodology

SHIELD aims to assess the safety and efficacy of SB-030 in reducing restenosis following angioplasty, a common treatment for peripheral artery disease. The trial will uniquely incorporate SB-030 in conjunction with standard balloon angioplasty and compare outcomes against balloon angioplasty alone. The primary concern is the potential reduction of occlusions within the femoral artery.

Nathan Bachtell, M.D., Chief Medical Officer at Symic Bio, expressed his enthusiasm for the trial, noting, “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.” Top-line results from the SHIELD trial are expected to be released in the fourth quarter of the year.

Potential Impact and Future Prospects

The trial is a proof-of-concept study designed as a parallel and blinded clinical study, with patients randomized in a 2:1 ratio. Michael Conte, M.D., Professor and Chief of the Division of Vascular & Endovascular Surgery at the University of California, San Francisco, and Co-Director of the UCSF Center for Limb Preservation commented, “If successful, positive proof-of-concept results will pave the way for additional studies of SB-030 in endovascular and surgical indications.”

SB-030 is administered once during a vascular procedure, binding to the exposed tissue caused by the injury. The drug targets the extracellular matrix, a critical component in the natural healing process of the vessel, aiming to reduce scarring and promote quicker healing.

The innovative approach taken by Symic Bio could potentially set a new standard in the treatment of peripheral artery disease if the trial results confirm the efficacy and safety of SB-030. By focusing on the matrix biology aspect, Symic Bio is exploring a niche yet crucial area of vascular health, which could lead to significant advancements in medical treatments for vascular complications.

  angioplasty, clinical trial, matrix biology, peripheral artery disease, restenosis, SB-030, Symic Bio, vascular health, vascular procedures