Symic reports Phase I/II data for SB-030 in peripheral vascular disease

Symic Bio Inc. (Emeryville, Calif.) reported data from the single-blind, Australian and New Zealand Phase I/II SHIELD trial in 67 patients with symptomatic peripheral vascular disease undergoing angioplasty showing that SB-030 (SBVC) significantly reduced index limb re-intervention at 12 months by 23% vs. balloon angioplasty alone (p=0.025).

At 24 weeks, SB-030 non-significantly improved mean late lumen loss by 32% vs. the control arm (p=0.165). Symic said the statistical assessment was affected by a smaller than expected control arm, "non-normal data distribution" and a higher rate of bailout procedures in the control arm (9% for SB-030 vs. 38% for control, p=0.006)...