A Novel Drug for Treating Chronic Neuropathic Pain: Discovery and Development

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A Novel Drug for TreatingChronic Neuropathic
PainDiscovery and Development

• Lei Yu, Ph.D.
• Rutgers University

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Neuropathic Pain Unmet Medical Need

• Chronic, often life-long suffering
• 6 million people affected in USA
• No more than 50 of the patients receive PARTIAL
  relief thru treatment due to
• Inadequate pharmaceutical treatment options
  because of
• Lack of well-defined molecular targets for drug
  development

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Neuropathic Pain Drug Development Opportunities

• Currently on the market 4 types of drugs
• Opioids
• Antidepressants
• NSAIDs
• Anticonvulsants
• Unmet medical needs large market
• Pregabalin (Pfizer Lyrica) an anticonvulsant
  for neuropathic pain / seizures, 3BB 2010 sales
• Plenty of room for new drugs
• Our strategy
• Neuropathic pain animal model (CCI) gt gene
  candidates gt synthetic oligonucleotide as
  antagonist drug gt treatment for pain relief

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Effectiveness in treating neuropathic
pain Animal studies
Antagonize over-activity Inhibit neuropathic pain
Drug use in normal animals No observable side
effect
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Next Steps in Drug Development

• Preclinical work
• Analgesic efficacy vs. current drugs on the
  market
• Formulation
• Pharmacokinetics
• ADME / toxicology
• Formulate oligonucleotide, test in animals
• File IND with FDA
• Clinical studies