FDA places partial clinical hold on Bright Minds Biosciences' BMB-101 DEE study

The FDA notified Bright Minds Biosciences that its IND for BMB-101 in developmental and epileptic encephalopathies has been placed on a partial clinical hold. The hold covers only the planned Phase 2 trial in the US. The FDA cited identified toxicity in mice and inadequate pharmacokinetic and juvenile toxicity data to support pediatric enrollment. The company believes the mouse findings were incidental and not drug-related. Bright Minds is awaiting the full hold letter and intends to work with the FDA to address the issues.