Bright Minds Biosciences launches Prader-Willi Syndrome program

Bright Minds Biosciences Inc. (NASDAQ: DRUG) announced the initiation of its Prader-Willi Syndrome program and nominated BMB-105 as a new clinical candidate. The company will commence a Phase 2a study called NOVA to assess the efficacy, safety and tolerability of BMB-101 for treating patients with PWS.

The NOVA study is designed as a proof-of-pharmacology study to demonstrate that 5-HT2C agonism will address symptom complex in PWS patients. Bright Minds will also conduct a randomized Phase 1 placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and food effect of BMB-105 in healthy volunteers.

Following completion of the Phase 2a study with BMB-101, the company plans to select and advance BMB-105 as the dedicated compound for the PWS program. This approach will reduce time to market by approximately one year, according to the press release.

The company provided an operational update for BMB-101 in absence seizures and developmental and epileptic encephalopathies. BMB-101 has been well tolerated with no drug-related serious adverse events or safety signals requiring protocol adjustments. Nearly all eligible patients elected to remain on therapy in the open-label extension. Top-line data will be released in early January 2026.

The NOVA clinical study is a double-blind, randomized Phase 2a study lasting up to 16 weeks. The primary objective is to assess the effect of BMB-101 on hyperphagia-related behaviors in patients with PWS. The primary endpoint measures change from baseline in Hyperphagia Questionnaire for clinical trials scores over time.

Prader-Willi syndrome affects approximately one in every 15,000 live births. The condition's hallmark feature is hyperphagia, marked by an unrelenting feeling of hunger and lack of normal satiety. There are currently no drugs that adequately address the neurological and behavioral challenges associated with PWS.

Bright Minds will host a webcast on November 6, 2025, at 10 a.m. ET featuring key opinion leaders discussing the PWS program and NOVA study.

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