Bright Minds Biosciences Provides Update About Planned Study with BMB-101 in Developmental and Epileptic Encephalopathies
The FDA has placed Bright Minds Biosciences' IND for BMB-101 in Developmental and Epileptic Encephalopathies on partial clinical hold, blocking the planned randomized, placebo-controlled Phase 2 trial in the United States. The FDA's stated concerns are identified toxicity in mice and inadequate pharmacokinetic and juvenile toxicity data to support proposed pediatric enrollment; the company disputes the mouse findings as incidental but acknowledges they are not FDA findings. The hold does not affect other ongoing trials, and the FDA will issue its full Partial Clinical Hold Letter within 30 days. There is no assurance of when or whether the hold will be lifted, leaving the U.S.
Key figures
- Drug Name
- BMB-101
- Phase Of Trial
- Phase 2
- Hold scope
- partial clinical hold on planned Phase 2 DEE trial in the U.S.; other ongoing trials unaffected
- Fda concerns
- toxicity in mice; inadequate pharmacokinetic and juvenile toxicity data for proposed pediatric enrollment
- Fda letter timing
- within 30 days
- Subjects dosed to date
- 90
- Dee seizure reduction median
- 63.3%
AI analysis
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