Symic Bio announced results from the Phase 1/2 SHIELD trial evaluating SB-030, a locally administered therapeutic, in patients with peripheral vascular disease undergoing angioplasty. In this first-in-human, prospective, randomized, single-blind controlled study of 67 patients, SB-030 demonstrated a positive safety profile, with no clinically meaningful difference observed in adverse events between treatment and control groups. In addition, treatment with SB-030 demonstrated potential for improvements as compared to control across measurements of clinical efficacy in late lumen loss, target lesion revascularization and primary patency rate.
"These results demonstrate clear potential for SB-030 in vascular disease, providing the first clinical proof of concept for this new mechanism," Andrew Holden, MBChB, director of interventional radiology at the Auckland Regional Public Health Service and one of the lead investigators in the SHIELD trial said. "The promise of SB-030 in improving outcomes following vascular interventions is particularly striking given its unique mechanism of action and safety profile."
Of the per-protocol patients within the SHIELD trial at 24 weeks following treatment, SB-030 treatment demonstrated potential to improve angiographic measurements of vessel diameter relative to control, referred to as late lumen loss, with a 32 percent mean improvement that did not reach the level of statistical significance (p=0.165). Statistical assessment was impacted by a smaller than expected control arm, non-normal data distribution, and a higher rate of bailout procedures in the control arm. Bailout procedures, typically stents that are placed periprocedurally due to vasospasm, were required for 38 percent of patients in the control group as compared with 9 percent of patients in the SB-030 treatment group (p=0.006). Non-parametric testing of the distribution of measurements in late lumen loss demonstrated a statistically significant difference between treatment and control groups (p=0.018). SB-030 treatment also reduced the rate of target lesion revascularization (TLR) by 22 percent. In addition, interim results from the extension phase of the study show promising trends for improved primary patency rate at 12 months. Safety assessments were confirmed by an independent medical monitor.
SB-030 is in development to improve clinical outcomes following peripheral vein graft procedures. SB-030 is administered locally, acting on the extracellular matrix of exposed connective tissue. In targeting responses mediated by the extracellular matrix, SB-030 aims to reduce the scarring (neointimal hyperplasia) and blood clot formation that leads to vein graft failure. Beyond vein graft failure, SB-030 has potential applications for other types of vascular procedures, including coronary bypass and surgical intervention in late-stage kidney disease.
(All Rights Reserved)