Bright Minds provides clinical program updates, anticipated milestones

Bright Minds Biosciences provided an update on its clinical programs, anticipated upcoming milestones and strategic priorities for advancing its development pipeline of innovative treatments to heal the central nervous system and brain through the regulation of serotonin. Program Updates and 2023 Milestones: BMB-101: A highly selective and potent 5-HT2C agonist has entered first-in-human Phase I clinical evaluation. The trial is being 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. Three-part study to evaluate the safety, tolerability, pharmacokinetic, and food effect in healthy volunteers is underway.Part 1 – single ascending dose – completed; 4 cohorts – single dose; Reached the planned top dose, which approached preclinical exposure limits; Well tolerated with predictable PK; Most common adverse event was oral paresthesias from liquid formulation; Part 2 – food effect – completed; 12 subjects – crossover with and without breakfast; Well tolerated with and without food; Effect of food on BMB-101 levels was relatively small, and therefore BMB-101 can be administered without the need for fasting. Part 3 – multiple ascending dose – cohort 1 complete; 4 cohorts – twice a day dosing for 7 days after meals; Study completes in 2Q 2023; Good Manufacturing Practices production completed for BMB-101 drug substance and drug product. BMB-202: A highly selective 5-HT2A agonist, lead candidate within psychedelic program; Expected to enter first-in-human trial in late 2023; Dose range finding study completed; Ready for Good Laboratory Practice oxicology program.