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

Executive Summary

• Bright Minds Biosciences announced the launch of its Prader‑Willi Syndrome (PWS) program, nominating BMB‑105 as a new clinical candidate and commencing a Phase 2a “NOVA” proof‑of‑pharmacology study of BMB‑101 in PWS patients.
• A concurrent randomized Phase 1 placebo‑controlled study will evaluate safety, tolerability, pharmacokinetics and food effect of BMB‑105 in healthy volunteers.
• The company will host a live webcast on November 6, 2025 at 10 am ET featuring leading KOLs to discuss the PWS program, study design, and early clinical data; top‑line results are expected in January 2026.

Key Details

• Program Initiation: Bright Minds is initiating its PWS therapeutic program and naming BMB‑105 as the dedicated compound for future development.
• Phase 2a NOVA Study (BMB‑101):
• Double‑blind, randomized, placebo‑controlled; up to 16 weeks duration.
• Primary objective: assess impact on hyperphagia using the Hyperphagia Questionnaire for Clinical Trials (HQ‑CT).
• Secondary objectives/endpoints include caregiver and clinician global impression scales, CGI‑S/CGI‑I, and PWS behavioral profile measures.
• Dosing schedule: 4‑week screening → 4‑week ascending MTD titration → 8‑week maintenance; optional open‑label extension up to 9 months.
• Phase 1 Study (BMB‑105): Randomized, placebo‑controlled evaluation of safety, tolerability, PK and food effect in healthy volunteers.
• Operational Update – BMB‑101 (Absence Seizures & Developmental/Epileptic Encephalopathies):
• No drug‑related serious adverse events reported; exposure and tolerability align with Phase 1 expectations.
• Open‑label extension enrollment is strong, with most eligible patients electing to continue therapy.
• Top‑line data from the ongoing Phase 2a proof‑of‑pharmacology study expected early January 2026.
• Future Development Timeline: Plans for Phase 2/3 studies in Developmental and Epileptic Encephalopathies (DEE) slated for 2026, potentially accelerating market entry by ~1 year via the BMB‑105 pathway.
• Webcast Details:
• Date & Time: November 6, 2025, 10 am ET.
• Access link: https://app.livestorm.co/bright-minds-biosciences/announcement-of-pws-program (live and replay available in the Investors section).
• Key Opinion Leaders on Call:
• Dr. Theresa V. Strong, Ph.D. – Founder, Foundation for Prader‑Willi Research.
• Dr. Jennifer L. Miller, MD – Professor, Pediatric Endocrinology, University of Florida (expert in PWS hyperphagia).
• Elizabeth Roof, H.S.P., M.A. – Senior Research Specialist, Vanderbilt University (30 years experience with PWS/WS).
• CEO Quote: “The initiation of our PWS program and NOVA clinical study are exciting next steps… 5‑HT2C agonism offers a novel mechanism for PWS by targeting the underlying aspects of the disease.” – Ian McDonald, CEO & Co‑founder.

Notable Quotes

• Ian McDonald (CEO): “We believe it will pave the way forward for a pivotal study with BMB‑105… expedite the development of the drug that aims at directly targeting the pathophysiology of PWS.”
• Ian McDonald: “We are pleased to host world‑renowned experts on PWS who share our passion for discovering improved treatments for this complex and challenging neurodevelopmental disorder.”