Bright Minds Biosciences (“Bright Minds,” “BMB” or the “Company”)
(Nasdaq: DRUG) (CSE: DRUG), a biotechnology company focused on
developing novel drugs for the targeted treatment of
neuropsychiatric disorders, epilepsy, and pain, today 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 Phase I 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-time in-human studies.
BMB-101, a next-generation, 5-HT2C selective and biased agonist,
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.
“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,”
stated Dr. Revati Shreeniwas, Chief Medical Officer of Bright Minds
Biosciences.
The Phase I clinical trial is a three-part (single ascending
dose, food effects, multiple ascending dose) randomized,
placebo-controlled study of BMB-101 in approximately 76 healthy
volunteers, that is being conducted in Australia. The trial aims to
evaluate the safety, tolerability and other pharmacokinetics of
BMB-101 for use in Phase II clinical trials.
“Dosing the initial subject in the first-in-human trial of
BMB-101 is an exciting milestone for Bright Minds. 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,” stated Ian McDonald, CEO and Co-founder of Bright Minds
Biosciences.
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 Locaserin, 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 behavior and the modulation of behavioral
effects of psychostimulants, opioids, alcohol and nicotine. Over
the past decade, the various 5-HT receptor subtypes have been
cloned and characterized. Results of clinical trials and animal
studies indicate that 5-HT2C up 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.
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 population (Wu 2015).
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
potentially superior drugs to first-generation compounds, such as
psilocybin.
Forward-Looking Information and Additional Cautionary
Language
This news release contains statements and information that, to
the extent that they are not historical fact, may constitute
“forward-looking information” within the meaning of applicable
securities legislation. Forward-looking information may include
financial and other projections, as well as statements regarding
future plans, objectives or economic performance, or the assumption
underlying any of the foregoing. Forward looking information in
this news release contains information related to the Phase I
clinical trial and the future therapeutic potential of BMB-101.
This news release uses words such as “may,” “would,” “could,”
“likely,” “expect,” “anticipate,” “believe,” “intend,” “plan,”
“forecast,” “project,” “estimate,” “outlook,” and other similar
expressions to identify forward-looking information.
Forward-looking information involves significant risks,
assumptions, uncertainties and other factors that may cause actual
future results or anticipated events to differ materially from
those expressed or implied in any forward-looking statements and
accordingly, should not be read as guarantees of future performance
or results. Assumptions used to develop the forward-looking
information in this news release includes assumptions related to
completion of the Phase I drug trial as intended by the Company,
the continuation of all participants in the trial for the duration
of the trial, and continued positive results in relation to BMB-101
as a medication, including in respect of its safety.
Actual results, performance or achievement could differ
materially from that expressed in, or implied by, any
forward-looking information in this news release and, accordingly,
readers should not place undue reliance on any such forward-looking
information. Further, any forward-looking statement speaks only as
of the date on which such statement is made. New factors emerge
from time to time, and it is not possible for management to predict
all of such factors and to assess in advance the impact of each
such factor on the Company’s business or the extent to which any
factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements. The Company does not undertake any obligations to
update any forward-looking information to reflect information,
events, results, circumstances or otherwise after the date hereof
or to reflect the occurrence of unanticipated events, except as
required by law.
Investor Contacts:Lisa WilsonE:
lwilson@insitecony.comT: 917-543-9932
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