Bright Minds Biosciences Inc. (Bright Minds or the Company)
(NASDAQ: DRUG), a biotechnology company focused on developing novel
therapies for neurological and neuropsychiatric disorders, today
announced that it is once again collaborating with Firefly
Neuroscience, Inc. (Firefly) (NASDAQ: AIFF), an Artificial
Intelligence (AI) company developing innovative solutions that
improve brain health outcomes for patients with neurological and
mental disorders, to provide a full analysis of the
electroencephalogram (EEG) data in the Company’s BREAKTHROUGH
study, an open-label Phase 2 clinical trial evaluating the safety,
tolerability, and efficacy of BMB-101, a highly selective 5-HT2C
receptor agonist, in adult patients with classic Absence Epilepsy
and Developmental Epileptic Encephalopathy (DEE).
Bright Minds and Firefly have previously
collaborated successfully to analyze the data of the Company’s
first-in-human Phase 1 study of BMB-101 using Firefly’s advanced
artificial intelligence, FDA-cleared BNA™ technology platform.
The BREAKTHROUGH study is designed as a basket
clinical trial that will include patients diagnosed with either
Absence Epilepsy (with or without Eyelid Myoclonia) or DEE. This
group of disorders consists of a range of rare epilepsy disorders,
including Epilepsy with Eyelid Myoclonia (known as Jeavons
Syndrome). These conditions are characterized by refractory
seizures that are often resistant to current treatments. The
BREAKTHROUGH study is targeting enrollment of 20 adult participants
aged from 18 to 65 years old.
“After successful use of the BNA platform to
analyze the data from our Phase 1 study, we look forward to once
again collaborating with the Firefly team at the conclusion of our
Phase 2 program for our lead compound, BMB-101, to provide valuable
insights into the EEG recordings during the study,” said Ian
McDonald, Chief Executive Officer of Bright Minds Biosciences. “We
believe BMB-101 has the potential to be a best-in-class 5-HT2C
agonist. This compound is not only poised to make a significant
impact in both the DEE and Absence Epilepsy communities, but also
has broad applicability across the 30% of all epilepsy patients who
experience drug resistance.” About
BMB-101BMB-101 is a novel scaffold
5-HT2C Gq-protein biased agonist developed using structure-based
drug design. It was explicitly designed for chronic treatment of
neurological disorders where tolerance and drug resistance are
common issues. Biased agonism at the 5-HT2C receptor is one of its
key features and adds another layer of functional selectivity
within a well-validated target. BMB-101 works exclusively via the
Gq-protein signaling pathway and avoids beta-arrest in activation,
which is crucial to minimize the risk of receptor desensitization
and tolerance development. This provides a novel mechanism,
anti-epileptic drug designed to provide sustained seizure relief in
hard-to-treat patient populations. In preclinical studies, BMB-101
has demonstrated efficacy in animal models of Dravet Syndrome and
numerous models of generalized seizures.
In Phase 1 clinical studies, BMB-101 was given
to 64 healthy volunteers in a Single Ascending Dose (SAD), Multiple
Ascending Dose (MAD) and food-effects study. BMB-101 was
demonstrated to be safe and well tolerated at all doses. No Serious
Adverse Events (SAEs) were observed, and Adverse Events (AEs) were
mild in nature and in line with on-target effects for serotonergic
drugs.
An extensive target-engagement study was
conducted using both fluid biomarkers (transient prolactin release)
and physical biomarkers (Quantitative Electroencephalogram, qEEG).
Both methods confirmed robust central target engagement. A qEEG
signature typical for anti-epileptic drugs was observed, with a
selective depression of EEG power at frequencies observed during
epileptic seizures. Furthermore, a potentiation of frontal
gamma-power was observed in this study which could indicate the
potential for improved cognition.
About Bright Minds
BiosciencesBright Minds Biosciences is a biotechnology
company developing innovative treatments for patients with
neurological and psychiatric disorders. Our pipeline includes novel
compounds targeting key receptors in the brain to address
conditions with high unmet medical need, including epilepsy,
depression, and other CNS disorders. Bright Minds is focused on
delivering breakthrough therapies that can transform patients’
lives.
Bright Minds Biosciences has developed a unique
platform of highly selective serotonergic agonists exhibiting
selectivity at different serotonergic receptors. This has provided
a rich portfolio of NCE programs within neurology and
psychiatry.
About FireflyFirefly (NASDAQ:
AIFF) is an Artificial Intelligence (“AI”) company developing
innovative solutions that improve brain health outcomes for
patients with neurological and mental disorders. Firefly’s
FDA-510(k) cleared Brain Network Analytics (BNA™) technology
revolutionizes diagnostic and treatment monitoring methods for
conditions such as depression, dementia, anxiety disorders,
concussions, and ADHD. Over the past 15 years, Firefly has built a
comprehensive database of brain wave tests, securing patent
protection, and achieving FDA clearance. The Company is now
launching BNA™ commercially, targeting pharmaceutical companies
engaged in drug research and clinical trials, as well as medical
practitioners for clinical use.
Brain Network Analytics was developed using
artificial intelligence and machine learning on Firefly’s extensive
proprietary database of standardized, high-definition longitudinal
electroencephalograms (EEGs) of over 17,000 patients representing
twelve disorders, as well as clinically normal patients. BNA™, in
conjunction with an FDA-cleared EEG system, can provide clinicians
with comprehensive insights into brain function. These insights can
enhance a clinician’s ability to accurately diagnose mental and
cognitive disorders and to evaluate what therapy and/or drug is
best suited to optimize a patient’s outcome.
Please visit https://fireflyneuro.com/ for more
information.
Forward-Looking StatementsThis
news release contains “forward-looking information”. Often, but not
always, forward-looking statements can be identified by the use of
words such as “plans”, “expects”, “is expected”, “budget”,
“scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or
“believes” or variations (including negative variations) of such
words and phrases, or state that certain actions, events or results
“may”, “could”, “would”, “might” or “will” be taken, occur or be
achieved. Forward-looking statements in this news release include
design, progress, and completion of the BREAKTHROUGHStudy,
future clinical development of BMB-101, and future intended use or
therapeutic benefit of BMB-101 to treat refractory epilepsy
disorders. A variety of factors, including known and unknown
risks, many of which are beyond our control, could cause actual
results to differ materially from the forward-looking information
in this news release. These factors include the company’s financial
position and operational runway, regulatory risk to operating in
the pharmaceutical industry, and inaccuracies related to the
assumption made by management relating to general availability of
resources required to operate the studies noted in this news
release. Additional risk factors can also be found in the Company’s
public filings under the Company’s SEDAR+ profile at
www.sedarplus.ca. Forward-looking statements contained herein are
made as of the date of this news release and the Company disclaims
any obligation to update any forward-looking statements, whether as
a result of new information, future events or results or otherwise.
There can be no assurance that forward-looking statements will
prove to be accurate, as actual results and future events could
differ materially from those anticipated in such statements. The
Company undertakes no obligation to update forward-looking
statements if circumstances, management’s estimates or opinions
should change, except as required by securities legislation.
Accordingly, the reader is cautioned not to place undue reliance on
forward-looking statements.
The Canadian Securities Exchange has neither
approved nor disapproved the information contained herein and does
not accept responsibility for the adequacy or accuracy of this news
release.
Contact InformationAlex
VasilkevichChief Operating OfficerBright Minds Biosciences
Inc.Phone:
(414)7316422Email: alex@brightmindsbio.comWebsite: www.brightmindsbio.com
Investor RelationsLisa M. WilsonT:
212-452-2793E: lwilson@insitecony.com
Bright Minds Biosciences (NASDAQ:DRUG)
過去 株価チャート
から 11 2024 まで 12 2024
Bright Minds Biosciences (NASDAQ:DRUG)
過去 株価チャート
から 12 2023 まで 12 2024