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BMB-101 · 3 trials · 6 indications
The Hyperphagia Questionnaire for Clinical Trials consists of 9 items; each rated on a scale from 0 (no symptoms) to 4 (severe symptoms). The total score ranges from 0 to 36, with higher scores indicating worse hyperphagia symptoms. A score of approximately 13 is associated with moderate to severe hyperphagia, and a score of 22 or greater is associated with severe hyperphagia.
Seizure diary
24 hour EEG
Incidence and severity of adverse events, including serious adverse events and adverse events, clinically significant changes in laboratory testing, vital signs, Holter monitoring, physical examination, and ECGs
Type of Suicidal Ideation, Intensity (1 - 5, with 5 being most severe), Suicidal Behavior
| Arm | Type | Description |
|---|---|---|
| BMB-101 | EXPERIMENTAL | Participants receive BMB-101 (10mg/mL liquid) orally |
| Placebo | PLACEBO_COMPARATOR | Participants receiving matched placebo orally |
| Name | Type | Description |
|---|---|---|
| BMB-101 | DRUG | Participants will receive weekly ascending oral doses of BMB-101(10 mg/mL) twice daily (BID) for 16 weeks. Doses will be based on weight (kg) and will initially start at 1.67 mg/kg. Doses may be titrated in 0.33 mg/kg increments based on tolerability up to a maximum dose of 2.0 mg/kg. |
| Placebo | DRUG | Matched Placebo |
Inclusion Criteria: * Participant must be aged 18-65 years (both inclusive). * Genetically confirmed diagnosis of Prader Willi Syndrome via standard DNA testing or other commonly approved methods. * Willing and able to provide voluntary written informed consent, or have a Legally Authorized Represe...
BMB-101 is an investigational small molecule being developed for neurological conditions including Prader-Willi Syndrome, absence epilepsy, and related developmental and epileptic encephalopathies such as Jeavons Syndrome, Dravet Syndrome, and Lennox Gastaut Syndrome. It is currently in clinical development and has not been approved by regulatory authorities.
BMB-101 targets the 5-HT2C receptor, a subtype of serotonin receptor involved in neurological signaling. By acting on this receptor, the drug is being studied for its potential effects in conditions like Prader-Willi Syndrome and absence epilepsy, though its exact mechanism of action in these disorders is still under investigation.
BMB-101 is being developed by Bright Minds Biosciences Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol DRUG. The company is conducting clinical trials to evaluate the safety and efficacy of BMB-101 in several neurological indications.
BMB-101 is in Phase 2 clinical development. It has completed a Phase 1 study in healthy volunteers and is currently being evaluated in Phase 2 trials for absence epilepsy and Prader-Willi Syndrome. The drug remains investigational and has not received FDA approval.
BMB-101 has been studied in three clinical trials. NCT05397041 was a completed Phase 1 study in healthy volunteers. NCT06401538 is a recruiting Phase 2 trial in absence epilepsy and related conditions. NCT07266324 is a not-yet-recruiting Phase 2 trial in Prader-Willi Syndrome. All trials are being conducted in Australia.
BMB-101 is the primary name for this investigational drug and no alternative names have been reported. It is a distinct small molecule targeting the 5-HT2C receptor, developed by Bright Minds Biosciences, and is not known to be identical to any other marketed or investigational medication.