FDA places partial hold on Bright Minds' seizure trial over mouse toxicity concerns
The FDA issued a partial clinical hold on Bright Minds Biosciences' planned phase 2 trial of BMB-101 in patients with developmental and epileptic encephalopathies.
The hold was triggered by preclinical toxicity findings in mice and the agency's concern that the company lacks sufficient pharmacokinetic and juvenile toxicity data to support enrolling children.
The company says the mouse toxicity appears isolated and unrelated to the drug, and it notes that other ongoing studies are not affected by the hold.
Shares of Bright Minds fell sharply after the announcement, dropping about half in pre‑market trading.
This writeup was produced by pharmadog from original reporting by Fierce Biotech.
Original headline: “FDA dims Bright Minds’ outlook with partial hold on seizure trial over toxicity in mice”
read at Fierce Biotech ↗
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