# Bright Minds Biosciences Announces Positive Topline Results From Phase 2 Clinical Trial Of BMB-101 In Patients With Absence Seizures And Developmental And Encephalopathic Epilepsies (DEE)

- URL: https://theranews.net/blog/2026-01-06-bright-minds-biosciences-announces-positive-topline-results-from-phase-2-clinica-db0a09/
- Published: 2026-01-06
- Type: Archive summary (AI-assisted summary of third-party reporting)
- Original outlet: menafn
- Original report: https://menafn.com/1110561748/Bright-Minds-Biosciences-Announces-Positive-Topline-Results-From-Phase-2-Clinical-Trial-Of-BMB-101-In-Patients-With-Absence-Seizures-And-Developmental-And-Encephalopathic-Epilepsies-DEE
- Topics: depression
- Publisher: TheraNews, operated by AdvancedCare USA Inc.
- Notice: Educational content, not medical, legal, billing or financial advice. Cite the original outlet, not this summary.

> BMB-101 demonstrated significant anti-seizure benefit in both cohorts with favorable safety and tolerability Absence: 73.1% median reduction in the number of ...

---
Bright Minds Biosciences announced positive topline results from its Phase 2 BREAKTHROUGH clinical trial evaluating BMB-101, a selective 5-HT2C biased agonist, in adult patients with drug-resistant Absence Seizures and Developmental and Encephalopathic Epilepsies (DEE). The study met its primary efficacy endpoints in both cohorts, demonstrating robust seizure reduction with a favorable safety and tolerability profile.

The Phase 2 open-label, multicenter study enrolled a total of 24 patients, exceeding the original target of 20. The study included a 4-week baseline, 4-week titration and maintenance period. The Absence cohort included 15 patients with a mean age of 30 years receiving a median of 3 concomitant anti-seizure treatments, while the DEE cohort included 9 patients receiving a median of 5 concomitant anti-seizure treatments. Participants had previously failed a mean of 3.7 antiseizure treatments for Absence and 9.8 for DEE.

## Efficacy Results

The Absence Seizures cohort (n=11) achieved a 73.1% median reduction in the number of absence seizures lasting 3 seconds or more (p = 0.012). Additionally, there was a 74.4% median reduction in total time in seizures during 24 hours. The DEE cohort (n=6) demonstrated a 63.3% median reduction in major motor seizures, with 60.3% reduction in Lennox-Gastaut Syndrome patients and 76.1% in other DEE patients. The DEE cohort included 4 Lennox-Gastaut Syndrome patients, 1 Dravet Syndrome patient (who previously failed fenfluramine for efficacy), and 1 Rett Syndrome patient.

## Safety and Additional Benefits

BMB-101 was generally well tolerated, with most treatment-emergent adverse events being mild (79.6%) or moderate (17.2%) and no treatment-related serious adverse events. The most common adverse events (10% or greater) included respiratory infections (20.8%), fatigue (16.7%), constipation (16.7%), headache (12.5%), and drowsiness (12.5%).

The study explored effects on sleep, finding a 90% increase in REM sleep duration, from 56.2 minutes at baseline to 106.7 minutes on BMB-101. Overall sleep duration remained unchanged. REM sleep is important for memory consolidation, emotional-behavior regulation and cognitive function. Bright Minds has initiated preparations for global registrational trials in Absence Seizures and DEE and plans to initiate a study in Prader Willi Syndrome, anticipated to begin in Q1 2026.

---

*This article is an AI-assisted summary. All facts and figures are drawn from the original report: [https://menafn.com/1110561748/Bright-Minds-Biosciences-Announces-Positive-Topline-Results-From-Phase-2-Clinical-Trial-Of-BMB-101-In-Patients-With-Absence-Seizures-And-Developmental-And-Encephalopathic-Epilepsies-DEE](https://menafn.com/1110561748/Bright-Minds-Biosciences-Announces-Positive-Topline-Results-From-Phase-2-Clinical-Trial-Of-BMB-101-In-Patients-With-Absence-Seizures-And-Developmental-And-Encephalopathic-Epilepsies-DEE)*