Development of a Non-Paralyzing BoNT-based Biopharmaceutical for the Treatment of Neuropathic Pain

National Center For Advancing Translational Sciences

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Abstract

The collaborators at Neuresta developed an attenuated BoNT/A, termed BiTox, with preliminary experiments demonstrating an ability to block neuropathic pain in rodents at low concentrations (ng/kg body weight) without causing detectable paralysis. BiTox is safely produced as two inactive subunits that are subsequently assembled into a stable functional complex for local administration to treat pain. Confirmatory in vivo studies are ongoing and preliminary data show comparable pain-relieving efficacy to BoNT/A in a rat pain model. The results of a bioassay in mice indicates that BiTox has about a 100-fold reduction in toxicity compared to native BoNT/A. Currently, the Chemistry, Manufacturing and Controls team is focused on developing safe and cost-effective manufacturing processes for the subunit components of BiTox to support a potential “bedside mixing” strategy of the two-component system.