BMB-101 / Bright Minds - LARVOL DELTA

Bright Minds Biosciences Announces Positive Findings from its DBA/2 Mouse Model Study Evaluating BMB-101 (GlobeNewswire) - "BMB-101 demonstrated a complete elimination of drop attacks in the DBA/2 mouse model; The DBA/2 model is highly predictive of sudden unexpected death in epilepsy (SUDEP); Findings highlight BMB-101’s potential to address critical gaps in SUDEP prevention."

Preclinical • Epilepsy

Bright Minds Biosciences to Host Virtual R&D Day on May 20, 2025; Program Highlights Include an Overview of Absence Seizures and the BMB-101 Phase 2 Study (GlobeNewswire) - "The webcast will include presentations from renowned Key Opinion Leaders (KOLs) in epilepsy research, as well as an overview of the Company’s BREAKTHROUGH study, an open-label Phase 2 clinical trial evaluating the safety, tolerability, and efficacy of BMB-101 in adult patients with classic Absence Epilepsy and Developmental and Epileptic Encephalopathy (DEE)."

Trial status • Absence Seizure Disorder

BMB-101 and Biased 5-HT2C Agonism: A Novel Approach for Sustained Epilepsy Management (AES 2024) - "BMB-101 is a novel 5-HT2C agonist developed by Bright Minds Biosciences Inc (USA) that belongs to a well-characterized class of tranylcypromine scaffold...BMB-101 shows a greater preference for Gq dissociation agonist activity versus β-arr1 and β-arr2 recruitment activity compared to Lorcaserin, thus demonstrating Gq-biased agonism. Based on the currently available data, BMB-101 is the only compound in clinical development (phase II anticipated Q4 2024) that has shown to be a "biased" or "functionally selective" 5-HT2C agonist, which means that it only targets one of the GPCR pathways... Based on the currently available data, BMB-101 is the only compound in clinical development (phase II anticipated Q4 2024) that has shown to be a "biased" or "functionally selective" 5-HT2C agonist, which means that it only targets one of the GPCR pathways. This is of utmost importance since βArr activation is associated with steric hindrance of..."

CNS Disorders • Epilepsy

BMB-101 in Absence Epilepsy and DEE (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Bright Minds Biosciences Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Absence Seizure Disorder • CNS Disorders • Epilepsy

Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Novel 5-HT2C Agonist, BMB-101, in Fed and Fasted Adult Healthy Human Volunteers (AES 2024) - "Fenfluramine has been approved for treating Dravet Syndrome and Lennox-Gastaut Syndrome, showing efficacy in reducing seizure frequency. The Phase 1 trial of BMB-101 has shown a favorable safety and pharmacokinetic profile, paving the way for its continued investigation in epilepsy patients. Due to its high selectivity and safety, BMB-101 holds promise as a 5-HT2C agonist for treating seizures in DEEs and certain generalized epilepsies. Further clinical trials are planned to establish proof of concept in rare epilepsy conditions."

Clinical • P1 data • PK/PD data • Cardiovascular • CNS Disorders • Epilepsy • Mental Retardation • Pain • Psychiatry

BMB-101 in Epilepsy With Eyelid Myoclonia (EEM) (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Bright Minds Biosciences Pty Ltd

New P2 trial • CNS Disorders • Epilepsy

A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=81 | Completed | Sponsor: Bright Minds Biosciences Pty Ltd | Recruiting ➔ Completed

Trial completion

BMB-101 – a Selective 5-HT2C Receptor (5-HT2CR) Agonist that May Have Utility in Substance Abuse Disorders (ASCP 2023) - "The efficacy of the anti-obesity medication fenfluramine was based upon its indirect actions as a 5-HT2CR agonist, however its dual action as a 5-HT2BR agonist resulted in its withdrawal due to cardiac toxicity. Studies with the 5-HT2CR agonist lorcaserin suggest efficacy to suppress relapse vulnerability in smoking, cocaine and cannabis, but lorcaserin is not a selective 5-HT2CR agonist...In the present studies, we tested the hypothesis that BMB-101 would attenuate fentanyl self-administration in rats and describe preliminary safety, tolerability and pharmacokinetic (PK) properties in humans in preparation for proposed Phase 2 studies in SUDs... Based on preclinical evidence described in the opioid use model, as well as the developing safety and tolerability profile in humans, we believe that BMB-101 may be a “best in class” 5-HT2CR agonist suitable for testing in substance abuse and other disorders. Learning Objectives To learn about the development of BMB-101 as a..."

CNS Disorders • Cognitive Disorders • Epilepsy • Pain • Substance Abuse

Bright Minds Biosciences Provides Clinical Program Updates and Outlines Anticipated Milestones for 2023 (BioSpace) - "First-in-human Phase 1 trial for lead program, BMB-101, a highly selective 5-HT2C agonist, is underway in Australia...'We are pleased with the progress of our Phase 1 first-in-human trial of BMB-101 and believe there are large potential market opportunities for the treatment of refractory epilepsies, beyond Dravet syndrome and a host of other indications, such as psychosis and addiction disorders.'"

Trial status • CNS Disorders • Epilepsy

A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Bright Minds Biosciences Pty Ltd | Trial completion date: Dec 2022 ➔ May 2023 | Trial primary completion date: Dec 2022 ➔ May 2023

Trial completion date • Trial primary completion date

Bright Minds Biosciences Initiates Dosing in Phase I Clinical Trial of BMB-101 for Dravet Syndrome (GlobeNewswire) - "Bright Minds Biosciences...announced that it has dosed the first patient in a Phase I trial (NCT 05397041) for its lead product, BMB-101, for the treatment of Dravet Syndrome and other medical indications. The Phase I trial is being conducted in Adelaide, Australia, by CMAX Clinical Research, a clinical trial center specializing in a range of early-phase trials and first-time in-human studies."

Trial status • CNS Disorders • Epilepsy

A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Bright Minds Biosciences Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open

A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=76 | Not yet recruiting | Sponsor: Bright Minds Biosciences Pty Ltd

New P1 trial

Bright Minds Biosciences to Host Key Opinion Leader Symposium on Dravet Syndrome (GlobeNewswire) - "Bright Minds Biosciences...announced that the Company will host a symposium with Key Opinion Leaders on Dravet Syndrome and recent therapeutic developments within the competitive landscape....The Company will provide an update on BMB-101, Bright Minds’ lead R&D program for the treatment of Dravet syndrome, and host a Q&A session with the KOLs."

Clinical • CNS Disorders • Epilepsy

Bright Minds Biosciences to Host Symposium on Therapeutic Developments within Dravet Syndrome and Featuring a Panel with Key Opinion Leaders (GlobeNewswire) - "Bright Minds Biosciences...announced that Ian McDonald, Chief Executive Officer, Dr. Revati Shreeniwas, Chief Medical Officer, Professor John McCorvy, PhD, Senior Advisor, and other key speakers will host a symposium on the recent therapeutic developments within the Dravet Syndrome landscape. The symposium will also include a panel with Key Opinion Leaders and a Q&A session. In addition, the Company and KOLs will also provide a developmental update on BMB-101, Bright Minds’ lead R&D program for the treatment of Dravet Syndrome."

Clinical • CNS Disorders • Epilepsy

Bright Minds Biosciences Announces Successful Completion of 28-Day Toxicology Studies and Advancement to First-in-Human Clinical Trial (BioSpace) - "Bright Minds Biosciences...announced the successful completion of 28-day repeat-dose toxicity studies for its lead product, BMB-101. Importantly, there were no major toxicological findings after twice daily oral administration of BMB-101 throughout the study period....'We are delighted to have completed this important milestone, which is pivotal for supporting our forthcoming first-in-human clinical trial, currently expected to begin in 2Q22...'"

New trial • Preclinical • CNS Disorders • Epilepsy

Bright Minds Biosciences Provides Scientific Update (GlobeNewswire) - "Bright Minds Biosciences...provided an update of significant scientific developments...5-HT2C Program for the Treatment of Dravet Syndrome and Selected Behavioral Disorders:...Identified Dravet Syndrome as lead indication for BMB-101. The Company demonstrated compelling efficacy signals with BMB-101 in well-established zebrafish models, with lower seizure duration and frequency. Advanced Investigational New Drug ('IND') enabling safety and toxicology studies, which bolster our confidence in commencing human trials in 1H 2022."

New trial • Preclinical • CNS Disorders • Epilepsy

Bright Minds Biosciences (“BMB”) Proprietary 5-HT2C Agonist Shows Significant Reduction in Seizure Activity (GlobeNewswire) - "Bright Minds Biosciences...announced that studies conducted with its BMB proprietary 5-HT2C agonist, BMB-101, showed efficacy in rodent models of Dravet Syndrome ('Dravet Syndrome')/Epilepsy...The Scn1Lab zebrafish experiments revealed that the Bright Minds 5-HT2C agonists reduced locomotor activity and the cumulative duration of epileptiform events in the brain. Bright Minds 5-HT2C agonists also showed efficacy in two validated rodent models, namely the mouse 6-Hz psychomotor seizure model, and the rat maximum electroshock ('MES') seizure model."

Preclinical • CNS Disorders • Epilepsy