Bright Minds Biosciences Initiates New Prader-Willi Syndrome (PWS) Program; KOL Event Scheduled for November 6TH

Core Viewpoint - Bright Minds Biosciences Inc. has initiated its Prader-Willi Syndrome (PWS) program and nominated BMB-105 as a new clinical candidate, aiming to address the unmet medical needs of patients with PWS through innovative treatment options [1][4][19]. Company Updates - The company will host a webcast on November 6, 2025, to discuss the Phase 2a study (NOVA Study) assessing the efficacy, safety, and tolerability of BMB-101 for PWS treatment [1][11]. - Key Opinion Leaders (KOLs) participating in the call include experts in the field of PWS, who will discuss the current therapeutic landscape and the challenges faced by patients and families [1][5]. - BMB-101 has shown strong pre-clinical and clinical rationale as a 5-HT2C agonist, potentially being the first on-target mechanism to address both neuropsychiatric symptoms and hyperphagia associated with PWS [1][4]. Clinical Development - Following the ongoing Phase 2a proof-of-pharmacology study with BMB-101, Bright Minds plans to advance BMB-105 as the dedicated compound for the PWS program, which is expected to reduce the time to market by approximately one year [2]. - The NOVA clinical study is designed as a double-blind, randomized Phase 2a study lasting up to 16 weeks, with a focus on assessing hyperphagia-related behaviors in patients with PWS [12][16]. - BMB-101 has been well tolerated in previous studies, with no serious adverse events reported, supporting its continued development [6][15]. About Prader-Willi Syndrome - PWS is a rare genetic neurodevelopmental disorder affecting approximately one in every 15,000 live births, characterized by hyperphagia and significant neurobehavioral challenges [13][14]. - Current treatments for PWS are inadequate, highlighting the need for novel therapeutic approaches that can effectively address both the physical and psychological aspects of the disorder [4][14]. About Bright Minds - Bright Minds is focused on developing innovative treatments for neurological and psychiatric disorders, with a pipeline that includes novel compounds targeting key receptors in the brain [19][20]. - The company aims to deliver breakthrough therapies that can transform the lives of patients suffering from conditions with high unmet medical needs, including epilepsy and PWS [19].