Sangamo Reports Top-Line Data From Phase II Diabetic Neuropathy Trial
Sangamo BioSciences, a developer of novel DNA-binding proteins for therapeutic gene regulation and modification, has announced top-line data from its SB-509-601 clinical trial, one of Sangamo’s three Phase II clinical studies from its ZFP therapeutic program to develop SB-509 for diabetic neuropathy.
The study is a double-blind, placebo-controlled, repeat-dosing multi- center study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs.
Approximately 110 subjects were enrolled into the trial. Subjects were randomized to one of two groups. The larger group was treated by intramuscular injection of 60mg of SB-509 (30mg of SB-509 per leg) into the lower limb every two months. The remaining group received an equal volume of placebo on the same schedule. Each subject received a total of three treatments (day 0, 60 and 120). Subjects received injections in a distribution pattern that targets the major peripheral nerves in the legs and feet.
The data demonstrate that repeat administration of the drug is well tolerated in subjects with mild to moderate diabetic neuropathy (DN). However, no significant differences were observed between the SB-509 and placebo treated subjects in a number of measures of nerve function and health at the primary analysis point, day 180 post-treatment, the company said.
Edward Lanphier, president and CEO of Sangamo, said: “The results from the SB-509-601 study are certainly unexpected. The data that we obtained on measures of nerve health and function are quite different than what we observed in our Phase Ib study. However, the 601 trial is only one part of our broad clinical development program to evaluate SB-509 which we will continue to prosecute.
“Based on our positive Phase Ib clinical data and encouraging interim data from our Phase II repeat-dosing study (SB-509-701A) in subjects with moderate to severe DN, we continue to have a high degree of confidence in this drug.”