FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold

Bright Minds Biosciences has said the U.S. Food and Drug Administration has placed its investigational new drug application for BMB-101 in developmental and epileptic encephalopathies on a partial clinical hold.

The decision affects the company’s planned U.S. Phase II study, Protocol BMB-101-105.

The proposed randomised, double-blind, placebo-controlled study was designed to assess the efficacy and safety of ascending doses of BMB-101 in patients with seizures associated with developmental and epileptic encephalopathies.

According to Bright Minds, the FDA identified toxicity findings in mice and insufficient pharmacokinetic and juvenile toxicity data to support the proposed paediatric enrolment.

The company said it believes the partial clinical hold applies only to the planned U.S. Phase II DEE trial and does not affect its other ongoing clinical studies.

Bright Minds also said the toxicity observed in mice had not been seen in other species.

The company added that, based on its toxicology reports, peer review and independent expert opinions, it believes the mouse findings were incidental and not related to BMB-101.

However, Bright Minds emphasised that this represents the company’s interpretation and does not resolve the FDA’s concerns.

The company is awaiting the FDA’s formal Partial Clinical Hold Letter.

The agency has indicated that the letter should be provided within 30 days and is expected to include additional details, non-hold recommendations and guidance on study design.

Bright Minds said it plans to seek further clarification from the FDA and review the agency’s recommendations before refining the proposed Phase II programme.

Additional preclinical data or studies may be required before the U.S. trial can move forward.

The company said there is no assurance as to when or whether the partial clinical hold will be lifted or future U.S. studies will be permitted to begin.

BMB-101 remains under development for developmental and epileptic encephalopathies, a group of severe neurological disorders characterised by treatment-resistant seizures and developmental impairment.

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