Bright Minds Biosciences Inc. (NASDAQ:DRUG) experienced a notable increase in its stock price after releasing preliminary results from its Phase 2 BREAKTHROUGH clinical study investigating the efficacy of its investigational drug BMB-101. The study focused on two cohorts: individuals with drug-resistant Absence Seizures and those diagnosed with Developmental and Encephalopathic Epilepsies (DEE), a collection of severe brain disorders marked by frequent seizures that often resist standard treatments.
DEE, characterized by repeated and drug-resistant seizures, has a profound impact on the typical developmental trajectory of affected individuals. These conditions frequently arise from genetic origins and result in significant delays or losses in fundamental developmental milestones, such as the ability to sit or speak, manifesting from early childhood.
In the trial, BMB-101 achieved its primary efficacy goal across both patient groups, showing a meaningful diminution in seizure frequency accompanied by a safety profile that supports tolerability and minimal severe adverse effects.
Absence Seizure Cohort Outcomes
Within the Absence seizure group, comprising 11 patients, data showed the following:
- A median reduction of 73.1% in the number of absence seizures lasting three seconds or longer, a result that reached statistical significance (p = 0.012) based on the Wilcoxon Signed Rank Test.
- A 74.4% median decrease in the total duration of seizures of three seconds or longer over a 24-hour timeframe (referred to as seizure burden), also statistically significant (p = 0.012).
Patients in this cohort exhibited substantial seizure abatement across seizure durations, demonstrating BMB-101’s potential effectiveness in managing absence seizures.
Developmental and Encephalopathic Epilepsies Cohort Results
The DEE cohort consisted of six participants who experienced the following outcomes:
- A median reduction of 63.3% in major motor seizures.
- A subgroup analysis indicated a median seizure reduction of 60.3% in patients with Lennox-Gastaut Syndrome (LGS), a subtype of DEE, and a more pronounced 76.1% reduction in patients with other forms of DEE.
Tolerability for BMB-101 was favorable, with most treatment-emergent adverse events classified as mild (79.6%) or moderate (17.2%) in severity. Importantly, there were no serious adverse events attributed directly to the treatment.
Additional Findings: Sleep Metrics
Beyond seizure control, the study assessed the impact of BMB-101 on sleep architecture. Improvements were observed in rapid eye movement (REM) sleep, which increased by 90% from baseline (an average of 56.2 minutes) to treatment with BMB-101 (average 106.7 minutes). Overall sleep duration remained essentially constant (9.1 hours at baseline compared to 8.9 hours during treatment).
The company highlighted REM sleep's role in critical physiological processes, including memory consolidation, regulation of emotional behavior, and cognitive function, suggesting that these improvements may translate into meaningful benefits for patients’ quality of life.
Future Directions
Following these encouraging topline results, Bright Minds Biosciences announced that preparations are underway for global registrational clinical trials targeting both Absence Seizure and DEE indications. The company plans to continue generating data on long-term outcomes and other efficacy metrics, with additional results to be disseminated over the course of the year.
In addition to its focus on epilepsy indications, Bright Minds has revealed plans to initiate a clinical study exploring BMB-101’s potential effects in Prader-Willi Syndrome, a genetic disorder with a complex clinical profile. This study is tentatively scheduled to commence in the first quarter of 2026.
Market Reaction
These clinical developments have been met with strong positive market sentiment. On the day of the Phase 2 topline data release, the company’s shares surged by 22.23%, reaching a price of $97.80 at the time of reporting.
Bright Minds Biosciences continues to be monitored closely by investors and analysts who are tracking the evolving data on BMB-101’s therapeutic efficacy and safety profile.