Core Insights - Bright Minds Biosciences Inc. has announced the addition of four global experts in Prader-Willi Syndrome (PWS) to its Scientific Advisory Board to support its PWS program, which includes the nomination of BMB-105 as a new clinical candidate [1][2] - The company aims to address the unmet medical needs associated with PWS, a complex neurodevelopmental disorder affecting approximately one in every 15,000 live births, particularly focusing on hyperphagia and behavioral symptoms [2][8] Company Developments - The company held a Key Opinion Leader (KOL) event on November 6, 2025, to announce the initiation of its PWS program and the nomination of BMB-105 [1] - The first proof-of-pharmacology clinical study will evaluate BMB-101's utility in addressing hyperphagia and behavioral/neuropsychiatric symptoms of PWS, which will inform the design of subsequent studies with BMB-105 [2] Scientific Advisory Board - The newly appointed experts include Tania Markovic, Jennifer L. Miller, Elizabeth Roof, and Theresa V. Strong, each bringing extensive experience in managing and researching PWS [2][3][4][6] - Their expertise will guide the company in clinical studies and address the quality-of-life challenges faced by patients and families [2] Clinical Study Overview - The NOVA clinical study is a double-blind, randomized, Phase 2a study lasting up to 16 weeks, with a 4-week screening period followed by a 1:1 randomization to either BMB-101 or placebo [7] - The study aims to assess the effect of BMB-101 on hyperphagia-related behaviors and associated behavioral disorders in PWS, with primary and secondary endpoints focused on various severity scores [10][11] About Prader-Willi Syndrome - PWS is characterized by hyperphagia, which poses significant health risks and affects daily life, with no current drugs adequately addressing these issues [8][9] - The disorder also includes neurobehavioral challenges such as emotional dysregulation and cognitive impairment, further impacting quality of life [9] About BMB-101 - BMB-101 is a novel 5-HT2C Gq-protein biased agonist designed for chronic treatment of neurological disorders, showing promise in preclinical studies for various conditions including PWS [10][11][12] - Phase 1 clinical studies demonstrated that BMB-101 was safe and well-tolerated, with no serious adverse events reported [12] Company Background - Bright Minds is focused on developing innovative treatments for neurological and psychiatric disorders, with a pipeline that includes compounds targeting conditions with high unmet medical needs [15][16]

Core Insights - Bright Minds Biosciences Inc. has announced the addition of four global experts in Prader-Willi Syndrome (PWS) to its Scientific Advisory Board to support its PWS program, which includes the nomination of BMB-105 as a new clinical candidate [1][2] - The company aims to address the unmet medical needs associated with PWS, a complex neurodevelopmental disorder affecting approximately one in every 15,000 live births, particularly focusing on hyperphagia and behavioral symptoms [2][9] Company Developments - The company held a Key Opinion Leader (KOL) event on November 6, 2025, to announce the initiation of its PWS program and the nomination of BMB-105 [1] - The first proof-of-pharmacology clinical study will evaluate BMB-101's utility in addressing hyperphagia and behavioral/neuropsychiatric symptoms of PWS, which will inform the design of subsequent studies with BMB-105 [2] Scientific Advisory Board Members - Tania Markovic, a leading expert in obesity management and Prader-Willi Syndrome, brings over 20 years of clinical experience [2] - Dr. Jennifer Miller specializes in the treatment of individuals with PWS and has been involved in clinical trials targeting hyperphagia for over 12 years [3] - Elizabeth Roof has nearly 30 years of experience working with children and teens with PWS and has managed multiple clinical trials in this area [4][6] - Dr. Theresa V. Strong has a background in medical genetics and has directed research programs focused on PWS [7] Clinical Study Overview - The NOVA clinical study is a double-blind, randomized, Phase 2a study lasting up to 16 weeks, with a 4-week screening period to establish the presence and degree of PWS symptoms [8] - Participants will be randomized in a 1:1 ratio to receive either BMB-101 or a placebo, followed by a Maximum Tolerated Dose (MTD) titration phase and a maintenance phase [8] Drug Information - BMB-101 is a novel 5-HT2C Gq-protein biased agonist designed for chronic treatment of neurological disorders, demonstrating efficacy in preclinical studies for various conditions including PWS [12][13] - In Phase 1 clinical studies, BMB-101 was shown to be safe and well-tolerated among 64 healthy volunteers, with no serious adverse events reported [13] Company Background - Bright Minds is focused on developing innovative treatments for neurological and psychiatric disorders, with a pipeline that includes compounds targeting conditions with high unmet medical needs [16][17]