Bright Minds Biosciences announced positive results of the qEEG data in Cohort 4 of its first-in-human Phase 1 study of its lead compound, BMB-101. On July 20, 2023, the Company announced completion of the study, along with positive topline data that demonstrated BMB-101’s excellent safety and tolerability profile in the single ascending dose, multiple ascending dose and food effects parts of the study. BMB-101 also demonstrated central target engagement and predictable plasma pharmacokinetics. In the qEEG study, BMB-101 demonstrated: Central target engagement, as the treatment group was easily identified in blinded data using qEEG power signature; A robust increase in central delta power and robust reduction in central alpha and beta power in active group, as previously reported for Anti-Epileptic Drugs, or AEDs,) in healthy individuals; Increased gamma frontal parietal connectivity in treatment group. This constitutes an improved AED principle over benzodiazepine AED drugs; Power and connectivity changes were concentration dependent. The Phase 1 study was conducted in Adelaide, Australia, by CMAX Clinical Research, a clinical trial center specializing in a range of early-phase trials and first-in-human studies. The study evaluated the safety, tolerability, pharmacokinetic, and food effect of BMB-101 in healthy volunteers.
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