Bright Minds Biosciences Inc. (CSE:DRUG) (NASDAQ:DRUG)
(“
Bright Minds” or the
“
Company”), a biotechnology company focused on
developing novel drugs for the targeted treatment of
neuropsychiatric disorders, epilepsy, and pain, today 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.
"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.
Program Updates and 2023
Milestones
BMB-101: A highly selective and potent 5-HT2C
agonist has entered first-in-human Phase I clinical evaluation. The
trial is being conducted in Adelaide, Australia, by CMAX Clinical
Research, a clinical trial center specializing in a range of
early-phase trials and first-in-human studies.
Three-part study to evaluate the safety, tolerability,
pharmacokinetic (PK), and food effect in healthy volunteers is
underway.
- Part 1 - single ascending dose - completed
- 4 cohorts (6 drug and 2 placebo) - single dose (oral
solution)
- Reached the planned top dose, which approached preclinical
exposure limits
- Well tolerated with predictable PK
- Most common adverse event was oral paresthesias from liquid
formulation
- Part 2 - food effect – completed
- 12 subjects - crossover with and without breakfast
- Well tolerated with and without food
- Effect of food on BMB-101 levels was relatively small, and
therefore BMB-101 can be administered without the need for
fasting.
- Part 3 - multiple ascending dose – cohort 1 complete
- 4 cohorts (6 drug and 2 placebo) – twice a day dosing for 7
days after meals
- Study (with results) completes in 2Q 2023
Good Manufacturing Practices (GMP) production completed for
BMB-101 drug substance and drug product.
BMB-202:
- A highly selective 5-HT2A agonist, lead candidate within
psychedelic program
- Expected to enter first-in-human trial in late 2023
- Dose range finding study completed
- Ready for Good Laboratory Practice (GLP) toxicology
program
Strengthened Leadership Team to Guide
Development Organization
- Appointed Mark A. Smith M.D., Ph.D., as Chief Medical Officer.
Dr. Smith is an experienced executive in CNS drug development and
has directed more than 50 clinical trials across all stages of
development. Dr. Smith brings an extensive background in psychiatry
that will guide the clinical implementation of the Company’s next
generation 5-HT2A agonists.
- Appointed Jan Torleif Pedersen, MSc PhD., as Chief Scientific
Officer. Dr. Pedersen brings 25+ years of expertise in neuroscience
research management and has a proven track record in major pharma
drug discovery and development.
- Appointed David Weiner, MD, to its board of directors as a
non-executive director. Dr. Weiner brings extensive experience in
the discovery and clinical development of novel therapeutics for
neurological, psychiatric and rare diseases.
Other Recent Developments
- Following the appointment of Dr. Weiner to the board of
directors and audit committee, the Company has regained compliance
with NASDAQ's independent director and audit committee
requirement.
- The Company will attend the BIO-Europe Spring Conference to be
held in Basel, Switzerland, March 20-22, 2023, and virtually, March
28-30, 2023.
About BMB-101
BMB-101, a 5-HT2C selective and biased agonist, has demonstrated
compelling activity in a host of in vitro and in vivo non-clinical
tests. Compared to Lorcaserin, BMB-101 exhibits strong Gq signaling
coupled with minimal beta-arrestin recruitment. Mechanistically,
Serotonin (5-Hydroxytryptamine, 5-HT) is a monoamine
neurotransmitter widely expressed in the central nervous system,
and drugs modulating 5-HT have made a major impact in mental health
disorders. Central 5-HT systems have long been associated with the
control of ingestive behaviors and the modulation of the behavioral
effects of psychostimulants, opioids, alcohol and nicotine. 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.
5-HT2C receptors are considered to be involved in epileptiform
activity and its activation is thought to have anticonvulsant
properties. In well-established and predictive animal models,
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.
About BMB-202
BMB-202 is a highly selective 5-HT2A agonist with proprietary
intellectual property. BMB-202 exhibits a more than 30-fold
selectivity over 5-HT2C and more than 500-fold selectivity over
5-HT2B. BMB-202 has shown two-fold superior potency compared to
psilocin in vitro. 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 antidepressant drug profile in vivo. BMB-202 is the
first clinical candidate from an extensive portfolio of selective
5-HT2A and 5-HT2A/2C agonists inspired from natural compound
scaffolds.
About Dravet Syndrome
Dravet syndrome is an epilepsy syndrome that begins in infancy
or early childhood and can include a spectrum of symptoms ranging
from mild to severe. Children with Dravet syndrome exhibit focal
(confined to one area) or generalized (throughout the brain)
convulsive seizures that start before 15 months of age (often
before age one). These initial seizures are often prolonged and
involve half of the body, with subsequent seizures that may switch
to the other side of the body. These initial seizures are
frequently associated with fever. Other seizure types emerge after
12 months of age and can be quite varied. Status epilepticus – a
state of continuous seizure requiring emergency medical care – may
occur frequently in these children, particularly in the first five
years of life. Dravet syndrome affects an estimated 1:15,700
individuals in the U.S., or 0.0064% of the population1.
Approximately 80-90% of those, or 1:20,900 individuals, have both
an SCN1A mutation and a clinical diagnosis of DS. This represents
an estimated 0.17% of all epilepsies. As an area of high, unmet
medical need, there currently exist only three FDA-approved
medications 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 focused on developing novel
transformative treatments for neuropsychiatric disorders, epilepsy,
and pain. Bright Minds has a portfolio of next-generation serotonin
agonists designed to target neurocircuit abnormalities that are
responsible for difficult to treat disorders such as resistant
epilepsy, treatment resistant depression, PTSD, and pain. The
Company leverages its world-class scientific and drug development
expertise to bring forward the next generation of safe and
efficacious drugs. Bright Minds’ drugs have been designed to
potentially retain the powerful therapeutic aspects of psychedelic
and other serotonergic compounds, while minimizing the side
effects, thereby creating superior drugs to first-generation
compounds, such as psilocybin.
Investor Contacts:Lisa WilsonE:
lwilson@insitecony.comT: 917-543-9932
Ian McDonaldCEO and DirectorE:
ian@brightmindsbio.comT: 917-543-9932
This news release includes certain statements
that may be deemed “forward-looking statements.” All statements in
this new release, other than statements of historical facts, that
address events or developments that the Company expects to occur,
are forward-looking statements. Forward-looking statements are
statements that are not historical facts and are generally, but not
always, identified by the words “expects,” “plans,” “anticipates,”
“believes,” “intends,” “estimates,” “projects,” “potential,” and
similar expressions, or that events or conditions “will,” “would,”
“may,” “could,” or “should” occur. Forward-looking information in
this news release includes statements related to BMB-101’s
potential use for treatments of refractory epilepsy, psychosis,
addiction, and other indications, BMB’s entry into human trials on
the schedule contemplated or at all and the result of such trials,
including the ability of BMB-202 to be utilized for treatment of
depression or at all, and the Company’s attendance at the
BIO-Europe Spring Conference. Although the Company believes the
expectations expressed in such forward-looking statements are based
on reasonable assumptions, such statements are not guarantees of
future performance and actual results may differ materially from
those in the forward-looking statements. Factors that could cause
the actual results to differ materially from those in
forward-looking statements include market prices, continued
availability of capital and financing, results of clinical trials
with respect to each of BMB-101 and BMB-202, regulatory conditions
with respect to in-human drug trials, and general economic, market
or business conditions. Investors are cautioned that any such
statements are not guarantees of future performance and actual
results or developments may differ materially from those projected
in the forward-looking statements. Forward-looking statements are
based on the beliefs, estimates and opinions of the Company’s
management on the date the statements are made. Except as required
by applicable securities laws, the Company undertakes no obligation
to update these forward-looking statements in the event that
management's beliefs, estimates or opinions, or other factors,
should change.
Neither the Canadian Securities Exchange nor its
Regulation Services Provider accepts responsibility for the
adequacy or accuracy of this release.
1 Wu, Yvonne W., et al. "Incidence of Dravet syndrome in a US
population." Pediatrics 136.5 (2015): e1310-e1315.
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