Shield Pharma LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Summary Shield Pharma and United States Department of AgricultureUSDAscientists recently discovered that bithionola compound with known antihelmintic propertiesacts as a hostoriented inhibitor of botulinum neurotoxin serotype ABoNT AEarly studies showed that bithionol inhibits BoNT A induced death in vivoBased upon these promising studiesShield Pharma is developing bithionol for the treatment of botulismCurrentlythe only available botulism treatments are intravenous biological drugsThe development of an oral small molecule drug to treat botulism would address an unmet medical needsince the current equine produced therapy requires more expensive manufacturingspecial storage and intravenous administrationThe specific aims of this project areto obtain literature that supports nonclinical and clinical safety and pharmacokinetics toxicokineticsto evaluate the pharmacokinetics and toxicity of bithionol in miceandto determine the therapeutic range and timinginterventive or prophylacticof bithionol against the most deadly BoNT serotypes ABand E using an in vivo Swiss Webster mouse model of botulism intoxication PROJECT NARRATIVE We discovered that a previously approved small moleculeacts as a host oriented inhibitor of botulinum neurotoxin serotype ABoNT AThis project will expand our work by testing this compound in vivo against the three most common serotypesA B Eacross a range of preand post exposure timingOverallthese efforts are intended to support a subsequent Phase II application to support a nonclinical programen route to commercializing an oral therapy against botulinum neurotoxin that is more easily manufacturedstoredand administered than existing treatments