Psychedelic biotechnology company Bright Minds Biosciences recently 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 company which focuses on developing novel drugs for the targeted treatment of neuropsychiatric disorders, epilepsy, and pain confirmed the launch of the trial which 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.
BMB-101 is a next-generation, 5-HT2C selective and biased agonist that exhibits compelling behavioral and preclinical pharmacology and safety data with the potential to be the best-in-class drug. In well-established, predictive animal models, BMB-101 demonstrated a significant reduction in both the number and intensity of epileptic seizures.
The Phase I clinical trial is a randomized, placebo-controlled study of BMB-101 that is currently being conducted in Australia with approximately 76 healthy volunteers. The purpose of the trial is to assess the safety and tolerability of BMB-101 in preparation for Phase II clinical trials.
CEO and Co-founder of Bright Minds Biosciences Ian McDonald was excited about the recent announcement adding commentary regarding the milestone.
“After several years of discovery and early development of next-generation, best-in-class serotonergic investigational drugs, we are delighted to progress into human trials. We are hopeful that our efforts result in more efficacious and safer drugs for patients suffering from Dravet Syndrome, which remains an area of high unmet medical need.”
What is Dravet Syndrome?
Dravet syndrome is an epilepsy disorder that transpires during infancy or early childhood. It can encompass a broad range of effects going from moderate to serious. Children with Dravet syndrome display focal (one-sided) or generalized (all-over) convulsive seizures that commence before they turn 15 months old (frequently before their first birthday).
Gradual onset, partial-brain involvement, and subsequent seizures that move to the other side of the body characterize these initial seizures. These initial fits are sometimes associated with a fever. Other seizure types may appear after 12 months of age and can be quite varied. Status epilepticus – a condition in which there is continual seizure activity requiring immediate medical care – may occur frequently in these youngsters, especially during the first five years of life.
Dravet syndrome affects 1:15,700 people in the United States, or 0.0064% of the population (Wu 2015). Approximately 80-90 percent of those with both an SCN1A mutation and a clinical diagnosis of DS (about 1:20,900 individuals), or 0.17% of all epilepsies.
According to the Food and Drug Administration, there are only three medications that have been approved for the treatment of DS: (1) Fintepla® (fenfluramine), which has a black-box label; (2) Diacomit® (stiripentol); and (3) Epidolex® (cannabidiol).
About Bright Minds
Bright Minds is a psychiatric pharmaceutical company striving to create new treatments for disorders that include, but are not limited to, resistant epilepsy and depression, PTSD, and pain. The company’s portfolio of serotonin agonists specifically targets the neurocircuit abnormalities that contribute to these difficult-to-treat diseases.
Bright Minds advocates for the next generation of safe and effective drugs by using its cutting-edge scientific and drug development skills. The company’s forward-thinking drugs have been created to maintain the potent therapeutic aspects of psychedelic compounds while simultaneously lessening side effects as much as possible, consequently making them better than first-generation serotonergic drugs like psilocybin.
Understanding BMB-101 from Bright Minds
BMB-101, a 5-HT2C selective and biased agonist, has demonstrated impressive activity in several in-vitro and live animal studies. When compared to Locaserin, BMB-101 exhibits much stronger Gq signaling along with minimal beta-arrestin recruitment.
In layman’s terms, serotonin is a monoamine neurotransmitter that has a wide presence in the central nervous system. Drugs regulating serotonin have had significant impacts on mental health disorders.
For many years, the central 5-HT systems have been connected to the management of ingestive behavior and how psychoactive drugs, opioids, alcohol, and nicotine affects someone’s behavior. In only the last decade have we characterized the various 5-HT receptor subtypes.
5-HT2C up receptors agonists may have therapeutic potential in the treatment of addiction by decreasing the intake of opioids and compulsive drug use, according to research.
Chief Medical Officer of Bright Minds Biosciences Dr. Revati Shreeniwas further elaborated on the drug stating, “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.”