Bright Minds Biosciences Provides Update About Planned Study with BMB-101 in Developmental and Epileptic Encephalopathies
Key Highlights
- ➤FDA places BMB-101 DEE Phase 2 U.S. trial on partial clinical hold
- ➤FDA cites mouse toxicity and insufficient pharmacokinetic and juvenile toxicity data
- ➤Partial hold does not affect Bright Minds’ other ongoing clinical trials
- ➤FDA expects full Partial Clinical Hold Letter within 30 days
- ➤Six DEE patients showed 63.3% median motor-seizure reduction in Phase 2
NEW YORK, Nov. 02, 2026 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (CSE: DRUG) (NASDAQ: DRUG) (“Bright Minds” or the “Company”) announces that the U.S. Food and Drug Administration (“FDA”) has notified the Company via email that its investigational new drug application (“IND”) for Developmental and Epileptic Encephalopathies (“DEEs”) and related Protocol BMB-101-105 has been placed on a partial clinical hold following the FDA’s review.
The proposed trial related to this IND is a randomized, placebo-controlled, double-blind Phase 2 study designed to evaluate the efficacy and safety of ascending doses of BMB-101, up to a maximum tolerated dose, for the treatment of seizures associated with DEEs.
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