Mr. Alex Vasilkevich reports

BRIGHT MINDS BIOSCIENCES ANNOUNCES POSITIVE FINDINGS FROM ITS DBA/2 MOUSE MODEL STUDY EVALUATING BMB-101

Bright Minds Biosciences Inc. has made positive findings from its DBA/2 mouse model study. BMB-101, the company's novel scaffold 5-HT2C Gq-protein-biased agonist, demonstrated a complete elimination of drop attacks in the DBA/2 mouse model.

"DBA/2 is an excellent model for understanding the effect of anti-epileptic drugs on the etiology of seizures," stated Jan Torleif Pedersen, PhD, MSc, director and chief science officer of Bright Minds Biosciences. "BMB-101 demonstrated dose-dependent efficacy in the DBA/2 mouse model of epilepsy, and drop seizures were completely eliminated. Notably, BMB-101 achieved 100-per-cent survival in the DBA/2 model, reversing brainstem serotonin deficits and preventing seizure-induced respiratory arrest. Sudep is the leading cause of seizure-related premature death, particularly in drug-resistant epilepsy patients, and we are extremely pleased to advance our investigative work and build on this preclinical validation."

The DBA/2 mouse model is an inbred mouse strain in which young DBA/2 mice are susceptible to audiogenic seizures, making them a model for epilepsy studies. This epilepsy model does recapitulate phenomenon such as tonic/clonic seizures, drop attacks and sudden unexpected death in epilepsy.

These findings highlight BMB-101's potential to address critical gaps in Sudep prevention, a leading cause of mortality in developmental and epileptic encephalopathy patients. For individuals with Dravet syndrome, the risk of premature death has been estimated as 15 to 20 per cent, with half or more cases attributed to Sudep.

About BMB-101

BMB-101 is a novel scaffold 5-HT2C Gq-protein-biased agonist developed using structure-based drug design. It was explicitly designed for chronic treatment of neurological disorders where tolerance and drug resistance are common issues. Biased agonism at the 5-HT2C receptor is one of its key features and adds another layer of functional selectivity within a well-validated target. BMB-101 works exclusively through the Gq-protein signalling pathway and avoids beta-arrestin activation, which is crucial to minimize the risk of receptor desensitization and tolerance development. This provides a novel mechanism, anti-epileptic drug designed to provide sustained seizure relief in hard-to-treat patient populations. In preclinical studies, BMB-101 has demonstrated efficacy in animal models of Dravet syndrome and numerous models of generalized seizures.

In phase 1 clinical studies, BMB-101 was given to 64 healthy volunteers in a single ascending dose, multiple ascending dose and food effect study. BMB-101 was demonstrated to be safe and well tolerated at all doses. No serious adverse events were observed, and adverse events were mild in nature and in line with on-target effects for serotonergic drugs.

An extensive target engagement study was conducted using both fluid biomarkers (transient prolactin release) and physical biomarkers (quantitative electroencephalogram). Both methods confirmed robust central target engagement. A qEEG signature typical for anti-epileptic drugs was observed, with a selective depression of EEG power at frequencies observed during epileptic seizures. Furthermore, a potentiation of frontal gamma power was observed in this study, which could indicate the potential for improved cognition.

About Bright Minds Biosciences Inc.

Bright Minds is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. Its pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, depression and other CNS disorders. Bright Minds is focused on delivering breakthrough therapies that can transform patients' lives.

Bright Minds has developed a unique platform of highly selective serotonergic agonists exhibiting selectivity at different serotonergic receptors. This has provided a rich portfolio of NCE programs within neurology and psychiatry.

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