Bright Minds Biosciences Expands Scientific Advisory Board to Include Renowned Experts in Prader-Willi Syndrome (PWS)
Executive Summary
- Bright Minds Biosciences announced the addition of four world‑renowned experts to its Scientific Advisory Board to support a newly launched Prader‑Willi Syndrome (PWS) program.
- The company disclosed the initiation of the “NOVA” Phase 2a clinical study evaluating BMB‑101 for hyperphagia and behavioral symptoms in PWS patients, with detailed design and primary/secondary endpoints.
- Forward‑looking statements indicate plans to advance BMB‑105 as a dedicated PWS compound and to pursue further Phase 2/3 studies in developmental epileptic encephalopathies (DEE) through 2026.
Key Details
- Advisory Board Appointees:
- Tania Markovic, MBBS PhD FRACP – Director, Metabolism & Obesity Services, Royal Prince Alfred Hospital, Sydney.
- Jennifer L. Miller, MD – Professor, Pediatric Endocrinology, University of Florida; follows >500 PWS patients worldwide.
- Elizabeth Roof, H.S.P., M.A. – Senior Research Specialist, Vanderbilt University; managed multiple NIH and clinical trials in PWS/WS.
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Theresa V. Strong, PhD – Adjunct Professor, Dept. of Genetics, UAB; founding member of the Foundation for Prader Willi Research.
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Program Background:
- On 6 Nov 2025, Bright Minds held a KOL event announcing the initiation of its PWS program and nomination of BMB‑105 as a dedicated clinical candidate.
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A replay of the presentation is available on the company’s Investor website.
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NOVA Phase 2a Study Design (BMB‑101):
- Double‑blind, randomized, placebo‑controlled; up to 16 weeks total duration.
- 4‑week screening → 1:1 randomization to BMB‑101 or placebo.
- 4‑week ascending Maximum Tolerated Dose (MTD) titration phase, followed by an 8‑week maintenance phase.
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Optional open‑label extension up to 9 months (or longer at investigator discretion).
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Primary Objective: Assess effect of BMB‑101 on hyperphagia‑related behaviors (change in Hyperphagia Questionnaire for Clinical Trials – HQ‑CT scores).
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Secondary Objectives & Endpoints:
- Change in caregiver‑global impression of severity (CaGI‑S) and clinician‑global impression scales (CGI‑S, CGI‑I).
- Evaluation of broader PWS behavioral issues via the PWS Profile.
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Safety and tolerability assessments throughout the study.
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BMB‑101 Background:
- Novel 5‑HT2C Gq‑protein biased agonist; preclinical efficacy in epilepsy, binge eating, aggression, substance use disorder, and cognitive decline models.
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Phase 1 data: safe & well‑tolerated in 64 healthy volunteers (SAD/MAD/food‑effects); robust central target engagement confirmed via prolactin release and qEEG biomarkers.
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Other Pipeline Activity:
- BMB‑101 is currently in a Phase IIa trial for Developmental and Epileptic Encephalopathies (DEE) and absence seizures.
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Company plans to advance BMB‑105 as the dedicated PWS compound and target Phase 2/3 studies in DEE by 2026.
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Forward‑Looking Statements: Include expectations around program timelines, regulatory approvals, site activation, patient enrollment, manufacturing supply, and clinical outcomes.
Notable Quotes
“We are thrilled to welcome these four accomplished scientists to our SAB in support of our new PWS program,” said Ian McDonald, CEO and Co‑founder.
“The first proof‑of‑pharmacology clinical study is designed to evaluate BMB‑101's utility in addressing both hyperphagia and the behavioral/neuropsychiatric symptoms of PWS.”