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September 1, 2022

Bright Minds begins subject dosing in Phase I Dravet syndrome trial

The trial will analyse the safety, tolerability, and other pharmacokinetics of the product to treat Dravet syndrome.

Bright Minds Biosciences has dosed the first subject in the Phase I clinical trial of its lead product, BMB-101, to treat Dravet syndrome and other disease indications.

The three-part, placebo-controlled, randomised trial will analyse BMB-101 in nearly 76 healthy subjects in Australia. 

It will assess the safety, tolerability, and other pharmacokinetics of the product for usage in Phase II trials.

Being carried out at the CMAX Clinical Research trial centre in Adelaide, Australia, the trial will have a single ascending dose, food effects, and multiple ascending dose phases.

A 5-HT2C selective and biased agonist, BMB-101 showed outstanding activity in various in-vitro and in-vivo non-clinical tests.

The product also offered a substantial decline in the number and severity of epileptic seizures in predictive animal models.

Bright Minds Biosciences chief medical officer Dr Revati Shreeniwas said: “BMB-101 was designed with the aim of improving the safety profile relative to earlier medications in this class, and we are excited about the potential to deliver an improved therapeutic to address this rare and devastating disease. 

“Based on the strength of BMB-101’s preclinical data and encouraging scientific rationale of 5-HT2C agonism in the treatment of Dravet Syndrome, we are enthusiastic to advance our lead product into clinical trials.”

An epilepsy condition, Dravet syndrome starts in infancy or early childhood. It can have a range of symptoms that are mild to severe. 

Children with Dravet syndrome have focal or generalised convulsive seizures that begin before 15 months of age.

The early seizures are frequently prolonged and affect half of the body while following seizures could switch to the other side of the body.

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