- Bright Minds Biosciences announces Phase 2 Clinical trial to
evaluate BMB-101 in a group of drug-resistant epilepsy disorders
with high unmet needs
- BMB-101 is a novel highly selective 5-HT2C agonist. Its
G-protein biased agonism provides an improved mechanism of action
for chronic dosing
- Financial runway extending into 2026 enabling key data
readout
- Conference call & KOL Event – will be held as a
webcast on September 25th at 10:00 ET
NEW
YORK, Sept. 12, 2024 /PRNewswire/ - Bright
Minds Biosciences Inc. (NASDAQ: DRUG), a biotechnology company
focused on developing novel therapies for neurological and
neuropsychiatric disorders, today announced the initiation of the
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).
Trial Design:
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 a 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.
- Study Duration: The trial includes a 4-week
baseline period where seizure activity will be monitored and
recorded to establish each participant's baseline seizure frequency
and EEG patterns. This will be followed by an 8-week (Absence
epilepsy group) to 12-week (DEE group) treatment phase where
participants will receive BMB-101. The study will conclude with a
4-week follow-up period to monitor for any lasting effects after
the cessation of the drug.
Endpoints: The study's objectives are to assess the
safety, tolerability and efficacy of BMB-101. The primary efficacy
endpoints are to evaluate the change in frequency of generalized
spike-wave discharges (GSWD) on 24-hour electroencephalogram (EEG)
in participants with Absence Epilepsy and the change in seizure
frequency on a daily seizure diary in participants with a DEE
compared to the baseline period.
- Open-Label Extension: There will be a planned
open-label extension trial lasting at least another 12 months that
will be an option for all subjects who respond to BMB-101 as agreed
upon by their physician.
"We are excited to advance BMB-101 into this next phase of
clinical development as we continue to build on the promising
safety and pharmacodynamic data from our Phase 1 trial," said
Ian McDonald, Chief Executive
Officer of Bright Minds Biosciences. "With its unique
pharmacological profile, we believe BMB-101 has the potential to be
a best-in-class 5-HT2C agonist. In our Phase 1 study, we
demonstrated central target engagement, which, in conjunction with
the wealth of 5-HT2C data within refractory epilepsies, gives us
great confidence in this study. 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. BMB-101 offers a
differentiated treatment option for patients with refractory
epilepsy, where current therapies often fall short, and could
provide a new standard of care for a much wider population of
epilepsy sufferers. We would like to thank the AECTN and the
Epilepsy Study Consortium for their contributions to our upcoming
study."
Corporate Update
Bright Minds remains committed to advancing the pipeline of
novel treatments for patients with significant unmet needs in
neurological disorders. Our financial position is expected to allow
the completion of the BREAKTHROUGH Study and sustain operations
into 2026. This financial stability allows us to maintain momentum
in our clinical programs and continue exploring additional
indications for BMB-101 and other assets in our pipeline.
Bright Minds is exploring the use of 5-HT2C compounds in
eating disorders and the management of obesity. Bright Minds will
also continue to advance its 5-HT2A and 5-HT2A/C programs within
neuropsychiatric disorders with a focus on major depressive
disorder, treatment-resistant depression and generalized anxiety
disorder.
Investor Call
Bright Minds Biosciences will host an investor call on
September 25, 2024 at 10:00 ET to discuss the BREAKTHROUGH Study. The
call will feature key opinion leaders (KOLs) in the field of
epilepsy who will provide insights into the significance of the
BREAKTHROUGH Study and the potential impact of BMB-101 on the
treatment landscape.
Registration and Participant Details:
Investors and interested parties can register for the call HERE
or by visiting the Bright Minds Biosciences website at
www.brightmindsbio.com. A replay of the call will be available
following the event.
About BMB-101
BMB-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-arrestin 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 Biosciences
Bright 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.
Forward-Looking Statements
This 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 BREAKTHROUGH Study, 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.
Website: www.brightmindsbio.com
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SOURCE Bright Minds Biosciences Inc.