FDA places partial clinical hold on Bright Minds Biosciences' planned BMB-101 epilepsy trial
DRUG•The FDA placed a partial clinical hold on Bright Minds Biosciences' planned US Phase 2 BMB-101 trial for developmental and epileptic encephalopathies, citing mouse toxicity findings and insufficient data to support pediatric enrollment.
1. FDA raises safety concerns
Bright Minds Biosciences said the FDA placed its planned US Phase 2 BMB-101 trial for developmental and epileptic encephalopathies on partial clinical hold. Regulators cited mouse toxicity findings and insufficient pharmacokinetic and juvenile toxicity data to support pediatric enrollment; the company believes the hold affects only the planned US trial, leaving other ongoing clinical trials unaffected.
2. Next regulatory steps
The company expects a full FDA hold letter within 30 days. Additional data or studies may be required, and there is no assurance when or whether the hold will be lifted or future US trials will proceed.
