Phase 1 trials are officially underway for Bright Minds Biosciences (CSE: DRUG) and their lead product, referred to as BMB-101. The firm this morning revealed that it has dosed the first patient under the trial as it looks to find a treatment for Dravet Syndrome, among other medical indications.
The product is classified as a next generation drug which has shown behavioural and preclinical pharmacology and safety data that suggests the formulation could be a a best-in-class drug. Predictive animal models have reportedly shown that the formulation significantly reduces both intensity and frequency of epileptic seizures.
The trial itself is said to consist of three parts, and is a randomized, placebo controlled study. The study is to examine single ascending dose, food effects, and multiple ascending doses under the program. The phase one trial is being conducted by CMAX Clinical Research in Adelaide, Australia, and is set to consist of 76 volunteers. The data from the program is intended to be used to evaluate the safety, tolerability, and other pharmacokinetics of the drug for use in phase two trials.
“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,” commented Bright Minds chief medical officer, Dr Revati Shreeniwas.
Dravet Syndrome is an epileptic syndrome that is said to begin in infancy or early childhood, and can range from mild to severe. It consists of focal or generalized convulsive seizures that are prolonged and involve half the body, with other seizure types emerging as the syndrome develops. Only three FA-approved drugs are currently available for treatment of the disease.
The development follows the firm last night closing its previously announced $4.0 million financing. The financing saw the company sell 2.9 million units of the firm at $1.40 per each, with each unit consisting of one common share and one purchase warrant. Warrants under the offering are valid through to August 30, 2024, and contain an exercise price of $1.76.
Bright Minds Biosciences last traded at $2.93 on the CSE.
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