BioElectron Update
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BioElectron provided an update on EPI-743, discussing the challenges of developing treatments for rare diseases like Leigh Syndrome including disease heterogeneity and lack of validated measures. They have completed 18 clinical trials treating over 400 patients with over 1 million doses, demonstrating safety, predictable pharmacology and clinical effects. Their next steps involve regulatory meetings in the US, EU and Japan to discuss approval of EPI-743 for Leigh Syndrome based on completing the non-clinical, manufacturing, regulatory and clinical portions of the New Drug Application process.
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BioElectron Update
- 1. EPI-743 Update BioElectron June 23, 2017 info@bioelectron.com © 2017 BioElectron Technology Corporation
- 2. Overview of Challenges Development Status Regulatory Process Next Steps Agenda © 2017 BioElectron Technology Corporation
- 3. Challenges Disease heterogeneity Absence of validated natural history Absence of validated clinical trial endpoints Patient logistics Absence of clinical/regulatory precedent Disease rarity Disease severity © 2017 BioElectron Technology Corporation
- 4. Development Status 18 clinical trials completed/ongoing >400 patients treated >1M clinical doses Safety & tolerability Predictable pharmacology Clinical effect © 2017 BioElectron Technology Corporation
- 5. New Drug Application Process: Leigh Syndrome 1. Non-clinical 2. Chemistry manufacturing and controls 3. Regulatory 4. Clinical © 2017 BioElectron Technology Corporation
- 6. Next Steps Regulatory meetings for EPI-743 approval: US, EU, & Japan © 2017 BioElectron Technology Corporation
- 7. © 2017 BioElectron Technology Corporation