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Ready for lift off
I'm assuming there's always a dark cloud over-head in your life on a daily basis
Do you enjoy doing this?
At present the reefer stocks are getting the bulls attention
As far as I know no psychedelic stock has produced a 10,000 percent return the way some reefer stocks did about five years ago
Those greedy shorts will be paying soon.
No reason whatsoever for it to be at this level
Holding strong all of my shares. I think the next run will surpass the momentum run that we had a week or so ago. September is upon us and history repeats itself. Very positive results with the clinical trial.
$DRUG
Timothy Sykes crew shorting this
I was actually at a break-even and decent profit in the pre-market yesterday but didn't pull the trigger to sell, because I recall the insane amount of short interest in this ticker and was hoping for some follow through during the session and in after-hours
But...that never happened.
Volume was completely incredible however, so it's safe to say we have a lot of fresh blood in this over $4 & $5/share
Looks like it will continue to go down since no new update from conference call. Also, there was no Q&A session for investor. It was just recording session.
-17.5% pre market
$3.44
From up over 100% pre-market to up only 18%.
Basically anyone that purchased shares today is at an incredible loss just in one session
The issue the press release explaining everything. They only have conference calls in case shareholders, potential investors, hedge fund managers and others have questions. I did not listen to the call so I do not know what the end result was but apparently it was nothing new outside of what was issued in the press release pre-market
It's shame on management. Why do they do conference call if there is nothing new to say.
$7.80 pre market
$3.73 after hrs
Definitely not what I was anticipating after an excellent news release and after hours conference call
30.6 MILLION shares exchanged hands today
2.9M share float????
3.8M shares in the OS ????
This forum is super active on twits but no one is posting here - volume is insane in relation to DRUG's O/S
I am hoping for good news during the call and analyst coverage after the call. I believe there might be an analyst coverage coming out after today's call.
From a high of $7.80 in pre-market down to $4 right now = no bueno
I told you guys. Consolidation is over. It's going to go up from here. Shories are in trouble.
Depends if there's a little more positive info released in today's conference call after hours
I believe this will go up from here. Selling is over and shorts are going to get into trouble after today's conference call.
Lots of profit taking by longs this morning. Let's see what comes of the conference call today at 430pm
That must have been nice to see pre market
Shorts won't be disturbed until the $7-8 area
Company to host webcast to discuss findings of the Phase 1 study today, August 8, 2023, at 4:30pm ET
Bye bye shorties!!!
Just jumped to $7.33
Fantastic news!!!
DRUG$$
GREAT NEWS TODAY = Bright Minds Biosciences Announces Positive qEEG (Quantitative Electroencephalogram) Data from its First-in-Human Phase 1 Study of Lead Compound, BMB-101
-- BMB-101 is a highly selective and potent 5-HT2C agonist being developed for the treatment of refractory epilepsies and other indications, such as psychosis, addiction, and impulse control disorders
-- qEEG study was conducted in healthy individuals in Cohort 4 of the Multiple Ascending Dose arm of the study
-- Proof of Mechanism and target engagement in the brain was established using blood biomarkers and qEEG
-- In qEEG, BMB-101 demonstrated robust increase in central delta power and robust reduction in central alpha and beta power in active group, as previously reported for Anti-Epileptic Drugs (AEDs) in healthy individuals
-- Company to host webcast to discuss findings of the Phase 1 study today, August 8, 2023, at 4:30pm ET
VANCOUVER, British Columbia, Aug. 08, 2023 (GLOBE NEWSWIRE) -- 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 and refractory epilepsy, today announced positive results of the qEEG (Quantitative Electroencephalogram) data in Cohort 4 of its first-in-human Phase 1 study of its lead compound, BMB-101. On July 20, 2023, the Company announced completion of the study, along with positive topline data that demonstrated BMB-101's excellent safety and tolerability profile in the single ascending dose, multiple ascending dose and food effects parts of the study. BMB-101 also demonstrated central target engagement and predictable plasma pharmacokinetics.
In the qEEG study, BMB-101 demonstrated:
Central target engagement, as the treatment group was easily identified in blinded data using qEEG power signature.
A robust increase in central delta power and robust reduction in central alpha and beta power in active group, as previously reported for Anti-Epileptic Drugs (AEDs) in healthy individuals.
Increased gamma frontal parietal connectivity in treatment group. This constitutes an improved AED principle over benzodiazepine (GABA receptor) AED drugs.
Power and connectivity changes were concentration dependent.
“The positive topline findings from our recently completed Phase 1 study of BMB-101, together with the observations from the qEEG portion of the study, validate our approach, as we continue to evaluate this important product candidate. BMB-101 is clearly [getting into the brain/achieving brain penetration] and activating the target receptors as we had predicted, setting us up for potential success in a number of indications that have been validated with the 5-HT2C mechanism. With this study complete, BMB-101 is now a Phase 2 ready asset, and we intend to move forward with an investigative new drug submission immediately,” stated Ian McDonald, CEO of Bright Minds.
“We are especially pleased that BMB-101 has demonstrated central target engagement by transient prolactin increase, and qEEG changes. The treatment group was readily identified in blinded data using the qEEG power signature. In addition, increased frontal gamma power represents an improved AED principle over [existing] benzodiazepine (GABA receptor) AED drugs. We believe that BMB-101 has the potential to be a best-in-class, novel pharmacophore 5-HT2C agonist for the treatment of seizure disorders, and our team is committed to advancing this product candidate for application where serotonin 2C agonists would be useful,” said Jan Torleif Pedersen, PhD, MSc, Chief Science Officer of Bright Minds.
During the EEG recording, subjects were seated with a U.S. Food and Drug Administration (FDA)- approved 19 electrode EEG headset provided by Zeto™ Inc. Channels were sampled at 250 or 500 Hz and referenced to A1/A2 channels (linked-ears reference) during recording. The EEG recording time was 10 minutes (~5 minutes resting with eyes closed and ~5 minutes resting with eyes open). There were four EEG recording timepoints: day 1 pre-dose (immediately before dosing) and post-dose (1h after dosing), and day 7 pre-dose and post-dose. Data were analyzed using the FireFly Neuroscience advanced EEG analysis platform.
BMB-101 is a highly selective and potent 5-HT2C agonist being developed for the treatment of refractory epilepsies and other indications, such as psychosis, addiction, and impulse control disorders. BMB-101 demonstrated an excellent safety and tolerability profile. 5-HT2C target engagement was demonstrated by transient, dose-dependent increases in prolactin. BMB-101 exhibited predictable plasma pharmacokinetics with relatively small inter-individual variability. The current formulation allows for twice-a-day oral dosing, and with further formulation development, there may be potential for once-a-day dosing. Based on these observations, the Company believes that moderate doses of BMB-101 will fully engage 5-HT2C receptors, and therefore not be dose-limited by side effects, which will help to achieve maximal efficacy in future Phase 2 studies. Dose limited side effects exhibited by first generation 5-HT2C agonists have prevented exploiting the full potential of this pharmacological mechanism.
The Phase 1 study was 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. The study evaluated the safety, tolerability, pharmacokinetic (PK), and food effect of BMB-101 in healthy volunteers.
About the Phase 1 Study
Part 1 – Single Ascending Dose
4 cohorts (6 drug and 2 placebo) – single dose (oral solution)
Reached the planned top dose of 180 mg/70 kg, which approached preclinical exposure limits
Well tolerated with predictable PK
Most common adverse event was oral paresthesias from liquid formulation
Part 2 – Food Effect
12 subjects – crossover with and without breakfast, 120 mg/70kg
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
4 cohorts (6 drug and 2 placebo) – twice a day dosing for seven days after meals Reached a top dose of 150 mg/70 kg twice a day
Biomarkers for central target engagement: Prolactin release and qEEG
Good Manufacturing Practices (GMP) production completed for BMB-101 drug substance and drug product.
Webcast Information
Bright Minds management will host a webcast to discuss the Phase 1 study as follows:
Date: Tuesday, August 8, 2023
Time: 4:30pm ET
Webcast link: Click here
About BMB-101
BMB-101, a highly selective 5-HT2C, Gq-protein biased agonist, has demonstrated compelling activity in a host of in vitro and in vivo nonclinical tests. Compared to Lorcaserin, BMB-101 exhibits strong Gq biased signaling, coupled with minimal beta-arrestin recruitment. Bright Minds believes that G-protein biased signaling translates to better tolerance profile for this second-generation 5-HT2C agonist, making BMB-101 a best-in-class 5-HT2C agonist. 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. BMB-101 is a new chemical entity (NCE) and constitutes a novel scaffold 5-HT2C agonist.
5-HT2C agonism is a well proven anticonvulsant mechanism. In translational 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 epilepsies. The Phase 1 trial (NCT 05397041) has been completed and BMB-101 is now Phase 2 ready.
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 treatment 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 fenfluramine, psilocybin, LSD, and ibogaine.
Investor Contacts:
Lisa Wilson
E: lwilson@insitecony.com
T: 917-543-9932
Ian McDonald
CEO and Director
E: ian@brightmindsbio.com
T: 917-543-9932
This news release includes certain statements that may be deemed “forward-looking statements.” All statements in th
$DRUG - 🚀Up 67% Pre-Market/ Current Price $5.59
Announces Positive qEEG (Quantitative Electroencephalogram) Data from its First-in-Human Phase 1 Study of Lead Compound, BMB-101
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