Bright Minds Biosciences has announced the commencement of the Phase II BREAKTHROUGH clinical trial of BMB-101, targeting adult patients with classic absence epilepsy and developmental epileptic encephalopathy (DEE).
BMB-101 is a highly selective 5-HT2C receptor agonist.
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The open-label Phase II trial is structured as a basket trial, encompassing patients diagnosed with either absence epilepsy or DEE.
These disorders, including Jeavons Syndrome, are known for seizures that often do not respond to existing treatments.
The BREAKTHROUGH study aims to enrol 20 adult participants aged between 18 to 65 years.
It will assess the safety, tolerability, and effectiveness of BMB-101 in adults with these epileptic conditions.
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By GlobalDataIt includes a four-week baseline period for monitoring and recording seizure activity to establish baseline seizure frequency and EEG patterns for each participant.
Following the baseline period, there will be an eight-week treatment phase for the absence epilepsy group and a 12-week phase for the DEE group, during which participants will be administered BMB-101.
The study will conclude with a four-week follow-up period to observe any persistent effects post-treatment.
The primary efficacy endpoints of the trial involve evaluating the change in the frequency of generalised spike-wave discharges (GSWD) on a 24-hour EEG for absence epilepsy participants and the change in seizure frequency based on a daily seizure diary for DEE participants, compared to the baseline.
Bright Minds Biosciences CEO Ian McDonald said: “We are excited to advance BMB-101 into this next phase of clinical development as we continue to build on the promising safety and pharmacodynamic data from our Phase I trial.
“In our Phase I study, we demonstrated central target engagement, which, in conjunction with the wealth of 5-HT2C data within refractory epilepsies, gives us great confidence in this study. This compound is not only poised to make a significant impact in both the DEE and absence epilepsy communities but also has broad applicability across the 30% of all epilepsy patients who experience drug resistance.”
