Symic Bio all set to begin peripheral artery disease drug trial
Symic Bio, a California based biopharma focued on matrix biology, is all set to begin the phase 1/2a clinical study named as SHIELD of its peripheral artery disease drug, SB-030.
The trial which will be held across multiple sites in Australia and New Zealand will feature 67 patients suffering from symptomatic peripheral artery disease.
SHIELD will study the safety and efficacy of Symic Bio’s peripheral artery disease drug (Pad drug), SB-030 in reducing restenosis post angioplasty. The Pad drug will be used only once for the treatment and will be locally administered.
SHIELD, in this connection, will compare SB-030 subjected along with balloon angioplasty against balloon angioplasty as the only treatment in the reduction of blood flow (occlusions) within the femoral artery.
Representative image of a clinical trial. Photo courtesy of jk1991/Freedigitalphotos.net.
Talking on the peripheral artery disease drug trial, Nathan Bachtell, M.D., Chief Medical Officer of Symic Bio said: “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.”
As per Symic Bio, the top-line results of the SHIELD trial of its peripheral artery disease drug are likely to come out in the fourth quarter of the year.
SHIELD expands to Study in Humans to Investigate the Efficacy and Safety of Luminal SB‐030 Delivery in peripheral artery disease. It will be a proof-of-concept parallel and blinded clinical study with the 67 enrolled 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 (UCSF), and Co-Director of the UCSF Center for Limb Preservation said: “If (SHIELD trial) successful, positive proof-of-concept results will pave the way for additional studies of SB-030 in endovascular and surgical indications.”
SB-030’s objective is to give better clinical outcomes after vascular procedures that are prone to cause vessel injury.
During a vascular procedure, SB-030 is intended to be given once, following which it binds to the exposed tissue caused by the injury.
An important component of the exposed tissue, the extracellular matrix plays a significant role in the natural healing of the vessel injury as per Symic Bio.
SB-030 looks to reduce the subsequent scarring (neointimal hyperplasia) besides promoting quicker healing after binding to the injured tissue and the extracellular matrix.