Bright Minds Biosciences' Investigational New Drug Application For Developmental And Epileptic Encephalopathies And Related Protocol BMB-101-105 Has Been Placed On Partial Clinical Hold Following FDA 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.

The Company believes that the partial clinical hold covers only the planned Phase 2 trial of BMB-101 in DEE in the United States, and the partial clinical hold does not affect the Company’s other ongoing clinical trials.

The primary reason given by the FDA relates to identified toxicity in mice, and inadequate pharmacokinetic and juvenile toxicity data to support the proposed pediatric enrollment.

The Company believes that the FDA’s observation of toxicity in mice was not seen in any other species. The Company further believes, based on its toxicity reports, peer reviewers, and multiple independent toxicology expert opinions, that the adverse mouse findings were incidental and not drug-related. These are the Company’s beliefs and should not be understood as the FDA findings or as resolving the FDA’s stated concerns.

The Company is awaiting the FDA’s full Partial Clinical Hold Letter. The FDA stated that it would provide the letter within 30 days, including additional details, non-hold recommendations, and study-design recommendations.

Bright Minds intends to immediately request further clarification from the FDA. The Company plans to review the FDA’s Partial Clinical Hold Letter and refine the study in accordance with the FDA’s recommendations with the objective of addressing the identified issues and advancing future U.S. clinical trials. Additional data or studies may be required, and there can be no assurance as to when or whether the partial clinical hold will be lifted or future U.S. trials will be permitted to proceed.