Debra BorchardtBright Minds Biosciences Inc. (CSE:DRUG) (NASDAQ:DRUG) provided an update on its clinical programs, anticipated upcoming milestones, and strategic priorities for advancing its development pipeline of innovative treatments to heal the central nervous system (CNS) and brain through the regulation of serotonin. Bright Minds has two psychedelic compound drugs called BMB-101 and BMB-202.
BMB-101
The company noted that BMB-101 demonstrated a significant reduction in both the number and intensity of epileptic seizures and is a promising candidate for the treatment of Dravet Syndrome and other forms of epilepsies. BMB-101 is currently being evaluated in a Phase I trial (NCT 05397041) designed to assess the compound’s safety, tolerability, pharmacokinetics, and food effect in healthy volunteers.
In addition to that treatment, the drug is also being looked at for addressing central 5-HT systems that have long been associated with addictions to psychostimulants, opioids, alcohol, and nicotine. The company said that results of clinical trials and animal studies indicate that 5-HT2C receptor agonists may have therapeutic potential in the treatment of addiction by decreasing the intake of opioids as well as impulsive behavior that can escalate compulsive drug use. BMB-101 has entered its first-in-human Phase I clinical evaluation.
BMB-202
Bright Minds said that the BMB-202 has shown two-fold superior potency compared to psilocybin in vitro. The drug was based on natural compounds. BMB-202 is a fast-acting, short-duration, Cmax driven compound. “We call these fast-on-fast-off compounds with anticipated patient discharge around two hours. BMB-202 exhibits excellent drug-like properties and brain penetrance and has demonstrated an antidepressant drug profile in vivo.” It is expected to enter the first-in-human trial in late 2023.
“This is an exciting time for Bright Minds, as the company successfully transitions from a discovery to a development organization. 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. Through an extensive medicinal chemistry and rational drug design program, Bright Minds has successfully developed 5-HT2C, 5-HT2A and 5-HT2A/2C agonists devoid of 5-HT2B agonism. We are progressing our next-generation psychedelics program and have nominated two clinical candidates. BMB-202, a fast, Cmax driven 5-HT2A agonist for the treatment of depression, is expected to enter a first-in-human trial late this year. The team has put in place a top-tier development organization with clinical, regulatory, manufacturing, and controls functions for future product pipeline investigational new drug submissions in the United States. In addition, last May, we established a scientific advisory board consisting of preeminent physicians and scientists across mental health disciplines whose expertise will serve to aide in the development of our clinical programs,” said Ian McDonald, CEO and Co-founder of Bright Minds Biosciences.
NASDAQ Requirements
Earlier this month Bright Minds told investors that it had received a deficiency letter from the Nasdaq Stock Market stating that the resignation of Dr. Williamson from the company’s board of directors and audit committee, meant that the company didn’t meet the requirements for independent director and audit committees. The company quickly appointed David Weiner, MD, as a non-executive director to its board of directors. Weiner has over 25 years of experience in the discovery and clinical development of novel therapeutics for neurological, psychiatric and rare diseases. He began his career at ACADIA Pharmaceuticals, where he held a series of discovery research and clinical development roles working on multiple central nervous system (CNS) therapeutics, most notably pimavanserin, a 5-HT2A receptor inverse agonist, which is approved for the treatment of Parkinson’s disease psychosis.
