Phase 2 study of SB-509 for diabetic neuropathy (DN)

Sangamo BioSciences announced positive Phase 2 data from its ZFP Therapeutic program to develop SB-509 as a treatment for diabetic neuropathy (DN). The data was gathered from Sangamo’s SB-509-601 and SB-509-701B trials that demonstrated that SB-509 treatment resulted in clinically beneficial improvements in subjects with moderate and severe DN as compared to placebo.

In the first study, SB-509 improved regrowth of epidermal nerve fibers (ENF) in subjects undergoing a standardized injury (p-value = 0.02), and increased blood vessel growth into a healing biopsy site. Study data also demonstrated that elevated sICAM-1 levels may aid in the upfront identification of a target population of SB-509-responsive subjects and serve as a stratification variable to enable balancing of severity of vascular disease in treatment and placebo groups. Additionally, a statistically significant top line decrease in sVCAM-1 was seen in the SB-509 treated group (p-value = 0.03) compared to placebo (p-value = 0.33).  sVCAM-1 and sICAM-1 are serum biomarkers of blood vessel damage and inflammatory diseases such as type 2 diabetes.

The second study focused on patients with at least one unmeasurable nerve conduction velocity (NCV) who were administered SB-509 or placebo at 0, 60 and 120 Days. In subjects with clear sensory deficits (i.e. Lower Extremity Neurologic Sensory Examination (LENSE) score >10) there was a substantial benefit in the mean change in sural NCV (sNCV) from baseline at the 180 Day time point (+1.42 m/sec in the treated group; -1.14 m/sec in the placebo group, p-value = 0.07).  

SB-509 is an injectable plasmid encoding a DNA-binding zinc finger DNA-binding protein (ZFP) transcription factor (ZFP TF). It is designed to upregulate the endogenous expression of the gene encoding vascular endothelial growth factor (VEGF-A). VEGF-A has been demonstrated to have direct angiogenic, neurotrophic and neuroprotective properties.

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