IND-Enabling Pre-Clinical Studies of 2DG for Treatment of Epilepsy

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2-Deoxy-D-Glucose (2DG) has a broad spectrum of action against a variety of cellular and network mechanisms underlying epileptic seizures. 2DG also impairs the progression of kindled seizures when administered as long as 10 minutes after onset. This implies not only an anticonvulsant activity, but a potential for disease modification, with 2DG treatment potentially mitigating against chronic consequences of seizures, such as susceptibility to intractability and cognitive and memory dysfunction. These features distinguish 2DG from all currently marketed anticonvulsants. Moreover, pre-clinical toxicity studies and human Phase I/II clinical trials of 2DG for treatment of cancer have demonstrated that doses effective against seizures are well tolerated. The BrIDGs team collaborated on the completion of the following studies for 2DG: - Synthesis of Good Manufacturing Practice (GMP) and non-GMP material - Formulation development and manufacture of drug product to support Phase I studies - Pharmacokinetic/absorption, distribution, metabolism, and excretion (PK/ADME) studies - Investigational New Drug (IND)-directed toxicology