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MindMed Announces Positive Topline Results from Phase 2b Trial of MM-120 in Generalized Anxiety Disorder
https://www.businesswire.com/news/home/20231214537387/en/
– Trial met its primary endpoint with MM-120 demonstrating a statistically significant dose-dependent improvement in HAM-A scores four weeks after a single-dose –
– MM-120 100 µg demonstrated a clinically and statistically significant HAM-A reduction of 21.3 points, representing a 7.6-point improvement over placebo at Week 4 (p=0.0004, Cohen’s d effect size = 0.88) –
– Clinical response rate of 78% in 100 µg and 200 µg dose groups and 50% clinical remission rate in the 100 µg dose group at Week 4 –
– MM-120 was generally well-tolerated with mostly mild-to-moderate adverse events that occurred on dosing day –
– Company plans to hold an End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA) in the first half of 2024 and initiate a Phase 3 clinical program in the second half of 2024 –
– Conference call and webcast to take place today at 8:30 am EST –
December 14, 2023 07:30 AM Eastern Standard Time
NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced positive topline results from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) in generalized anxiety disorder (GAD). The trial met its primary endpoint, with MM-120 demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4. MM-120 was administered as a single-dose in a monitored clinical setting with no additional therapeutic intervention.
MM-120 100 µg – the dose achieving the highest level of clinical activity – demonstrated a 7.6-point reduction compared to placebo at Week 4 (-21.3 MM-120 vs. -13.7 placebo; p<0.0004; Cohen’s d=0.88). Clinical Global Impressions - Severity (CGI-S) scores on average improved from 4.8 to 2.4 in the 100 ug dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at Week 4 (p<0.001). This clinical activity was observed to be rapid and durable beginning on Day 2 and continuing through Week 4 with no loss of activity observed on either HAM-A or CGI-S.
“We are excited by the strong positive results for MM-120 in GAD, particularly given that this is the first study to assess the standalone drug effects of MM-120 in the absence of any psychotherapeutic intervention. These promising findings represent a major step forward in our goal to bring a paradigm-shifting treatment to the millions of patients who are profoundly impacted by GAD,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We look forward to sharing additional study results in the coming months – including topline 12-week results in the first quarter of 2024 – and working closely with FDA as we finalize the Phase 3 development program for MM-120 in GAD. I would like to thank all of the participants in the study as well as the study investigators and our clinical development team, whose dedication made this important milestone possible.”
Daniel Karlin, MD, MA, Chief Medical Officer of MindMed said, “Generalized anxiety disorder is a common condition associated with significant impairment that adversely affects millions of people and there remains a serious unmet need for this patient population. The pharmaceutical industry has largely ignored GAD over recent decades as it has proved extremely difficult to target. Few new treatment options have shown robust activity in GAD since the last new drug approval in 2004, making the strong, rapid, and durable clinical activity of a single dose of MM-120 observed in the trial particularly notable. We believe this study is the first to rigorously assess the efficacy of a drug candidate in this class in the absence of a concurrent therapeutic intervention, which brings hope to the millions of people suffering from GAD and provides additional evidence that MM-120 may play an important role in revolutionizing the treatment of brain health disorders.”
Additional secondary and exploratory endpoints included in the primary topline results included HAM-A response and remission rates and Clinical Global Impressions - Severity (CGI-S) scores. Clinical response (50% or greater improvement in HAM-A) at Week 4 was achieved in 78% of participants treated with MM-120 (100 µg or 200 µg) compared to 31% for placebo. Clinical remission (HAM-A ≤ 7) at Week 4 was achieved in 50% of participants treated with MM-120 100 µg. CGI-S scores demonstrated a statistically significant and clinically meaningful improvement compared to placebo in the 100 µg (p≤0.001) and 200 µg (p≤0.01) dose groups. On average, participants receiving MM-120 (100 µg or 200 µg) experienced a 2-unit improvement in the CGI-S score at Week 4, with statistically significant improvements observed as early as one day after treatment and continuing at all evaluated timepoints through Week 4.
MM-120 was generally observed to be well tolerated, with mostly transient mild-to-moderate adverse events (AEs) that appear consistent with the pharmacodynamic effects of MM-120. The overall four-week completion rate in the trial was approximately 90% and was 97.5% in the high dose groups, and no participants in the high dose groups discontinued due to an adverse event through Week 4. The most common adverse events (at least 10% incidence in the high dose groups) occurred on dosing day and included illusion, hallucinations, euphoric mood, anxiety, thinking abnormal, headache, paraesthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis.
The Company expects that results of this study will support the advancement of MM-120 into Phase 3 clinical development for GAD. The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate Phase 3 clinical trials in the second half of 2024. The Company expects to present additional topline 12-week data from the study in the first quarter of 2024 and to present full results at a scientific meeting in 2024.
Conference Call and Webcast
MindMed management will host a conference call at 8:30 AM EST today to discuss the results of MM-120 in GAD. Individuals may participate in the live call via telephone by dialing (877) 407-3982 (domestic) or (201) 493-6780 (international). The webcast can be accessed live here on the News & Events page in the Investors section of the MindMed website, https://mindmed.co/. The webcast will be archived on the Company’s website for at least 30 days after the conference call.
About Study MMED008
Study MMED008 is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial enrolled 198 participants who were randomized to receive a single administration of MM-120 at a dose of 25, 50, 100 or 200 µg or placebo. The full analysis set (FAS) for the trial included 194 subjects, those that had at least one valid post-baseline Hamilton Anxiety rating scale (HAM-A) score. Subjects enrolled in the trial presented with severe GAD symptoms (average baseline HAM-A scores of approximately 30). The primary objective of the study was to determine the dose-response relationship of four doses of MM-120 versus placebo as measured by the change in HAM-A from Baseline to Week 4. Secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, as well as other measures of efficacy and quality of life. More information about the trial is available on the MindMed website (mindmed.co) or on clinicaltrials.gov (identifier NCT05407064).
About MM-120
Lysergide is a synthetic tryptamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM-120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and ADHD.
About Generalized Anxiety Disorder
GAD is a brain health disorder that results in fear, persistent anxiety and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S. adults, representing around 20 million people, currently suffer from GAD, an underdiagnosed and underserved indication that is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2004.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
MindMed trades on NASDAQ under the symbol MNMD and on the Cboe Canada (formerly known as the NEO Exchange, Inc.) under the symbol MMED.
Last tree shaking I guess or tax harvesting.
I believe we are in the making for and end of year run :)
Thinking the same. Been gathering a bit over the past year.
What do you honestly think is going to happen here? It hurts to watch you guys think this is going anywhere back to what is was without an RS.
This is huge for the sector! Psychedelic Rally 2.0 incoming!
https://www.washingtonpost.com/business/2023/12/12/mdma-therapy-fda-maps/
This is huge for the sector! Psychedelic Rally 2.0 incoming!
https://www.washingtonpost.com/business/2023/12/12/mdma-therapy-fda-maps/
Not happening Bone... sorry bud...
This shit ticker ran its course a while ago. The best would be an RS to add volume. But the existing holders would be roasted.
Told you to sell almost a year ago but what the hell did I know then. ;)
Definitely hitting NASDAQ
This one is going to a dollar.
Q1 is going to be very nice in 2024... I am loaded
I think the end result will be bigger than the NASDAQ hype to be honest. The valuation will be a true one when they have a product close to market or they get bought out. Either way. Everyone will win buying down here. Phase 2 ;)
Last bit of tree shaking before takeoff.
Good morning. Ready for up up and away? This one will be a nice gemstone to grab and cherish.
Get in now before it goes to a buck!
These BIOTECH are getting ready to hit hard.
Was in for the run - now here for the long haul. You'll make money again here. BIG GAINS COMING!!!
This will hit close to a 1.00 if not more on the anticipation of joining the beloved NASDAQ :)
This is going to pass the peak in time. I rode from IPO to the BIG N and been buying back in... this will be unreal when they are bought out or bring a product to market.
All the shares I have now are riding until one of those two events occur. Enjoy!
Looking good to run here!
No you're not... better count your blessings instead of your shares here bone.
I just keep buying this at these levels. Just set and forget. One of the few I will hold into 2025-2026. They will get bought out or have a product lining up by then.
No way. Will run soon. One more good one in this script!
Got back in hard on this one. Coming soon!
End of year run coming up folks... get back in after the last run.
Hey just by a head count how many of you are gonna lose all you money here holding these hemp fiber bags of lead infused stevia while Ken medicates himself with the delta-9 cbd he bought with your blood money and life savings.
happy weekend! :)
Plenty of time after an RS ;)
Acute Effects of Psilocybin After Escitalopram or Placebo Pretreatment in a Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Healthy Subjects
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299061/
Common antidepressant escitalopram and psilocybin can be taken together safely: study
https://mugglehead.com/popular-antidepressant-escitalopram-and-psilocybin-can-be-taken-together-safely-study/
Happy Halloween! US Patent US-11801256-B2
Antidepressant-psilocybin co-treatment to assist psychotherapy
https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/11801256
Ive gobbled up a lot during this low period. Perfectly happy holding for a few years with my new found share floor.
We are not worried about decriminalization WQlf... We want pharmaceuticals and them made in a lab. the naturalists want the decriminalization. FuQ that.
You're not from around here are you?
Yes, but its a bullshit scheme to then short it below the requirement and the cycle continues. LOL!
ATAI LIFE SCIENCES ANNOUNCES FILING OF EARLY WARNING REPORT
https://www.newswire.ca/news-releases/atai-life-sciences-announces-filing-of-early-warning-report-886747079.html
News provided by
atai Life Sciences AG
10 Oct, 2023, 08:00 ET
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TORONTO, Oct. 10, 2023 /CNW/ - This press release is being issued pursuant to National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting Issues ("NI 62-103"), in connection with certain transactions completed by atai Life Sciences AG (Nasdaq: ATAI) ("atai") and IntelGenx Technologies Corp. (the "IntelGenx"), that were previously described in a press release issued by IntelGenx on August 31 2023.
On August 31, 2023, IntelGenx announced that, in connection with a non-brokered offering (the "Offering") of units (the "US Units"), each comprised of a US$1,000 principal amount convertible promissory note and 5,405 common stock purchase warrants, IntelGenx had agreed to, among other things: (i) enter into a second amendment (the "Second Amendment") to the amended and restated loan agreement dated as of September 14, 2021 (the "Loan Agreement") to provide, among other things, for the ability for atai to convert the principal and accrued interest outstanding under the Loan Agreement into common stock of IntelGenx ("Shares") at a price of US$0.185 per Share (the "Conversion Feature"); and (ii) enter into an amendment (the "Subscription Agreement Amendment") to the subscription agreement entered into by and between IntelGenx and atai in connection with the Offering, to provide atai with the right (the "Call Option") to purchase up to an additional 6,013 US Units at any time prior to August 31, 2026.
On October 6, 2023, atai and IntelGenx entered into the Second Amendment and the Subscription Agreement Amendment, both effective September 30, 2023 (the "Transaction"). In connection with the Second Amendment, atai and IntelGenx entered into a second amended and restated loan agreement to provide for the Conversion Feature. In connection with the Call Option, atai and IntelGenx entered into the Subscription Agreement Amendment, pursuant to which IntelGenx granted atai the option to purchase up to an additional 7,401 US Units (the "Call Option Units") at any time prior to August 31, 2026. Pursuant to the Subscription Agreement Amendment, the acquisition of any Call Option Units will result in a corresponding reduction in atai's remaining purchase right pursuant to the amended and restated securities purchase agreement dated May 14, 2021 (the "2021 Purchase Right"), with such right to be reduced by the maximum number of Shares issuable in connection with such Call Option Units, and (ii) in the event that the 2021 Purchase Right has been fully or partially exercised such that the aggregate number of Shares issued thereunder together with the number of Shares issuable in accordance with the Call Option would exceed 100,000,000, the number of Shares that may be issued in connection with the Call Option shall be reduced such that the aggregate number of Shares issued thereunder together with the number of Shares issuable in accordance with the Call Option does not exceed 100,000,000. The exercise of the Call Option is subject to the prior approval of the shareholders of IntelGenx.
Immediately prior to the Transaction, excluding Shares issuable upon the conversion of interest that may be outstanding from time to time, atai had ownership and control over securities convertible into approximately 269,152,849 Shares representing approximately 66.2% of the issued and outstanding Shares, on a partially diluted basis. Following the Transaction, assuming the conversion of the outstanding principal balance of the Loan Agreement and/or exercise of the Call Option (including the underlying securities) and excluding Shares issuable upon the conversion of interest that may be outstanding from time to time, atai would beneficially own or control in aggregate 237,732,850 Shares representing approximately 63.4% of the issued and outstanding Shares, on a partially diluted basis.
atai's acquisitions and dispositions were made in connection with atai's existing investment in IntelGenx. In accordance with applicable securities laws, atai may, from time to time and at any time, acquire additional shares and/or other equity, debt or other securities or instruments (collectively, "Securities") of IntelGenx in the open market or otherwise, and reserves the right to dispose of any or all of its Securities in the open market or otherwise at any time and from time to time, and to engage in similar transactions with respect to the Securities, the whole depending on market conditions, the business and prospects of IntelGenx and other relevant factors.
An early warning report will be filed under IntelGenx's profile on the SEDAR+ website at www.sedarplus.ca. To obtain more information or to obtain a copy of the early warning report filed in respect of this press release, please contact atai by email at ir@atai.life or by mail at c/o atai Life Sciences AG, Wallstraße 16, 10179, Berlin, Germany.
The mailing address of IntelGenx is located at 6420 Rue Abrams, Saint-Laurent, QC H4S 1Y2, Canada.
SOURCE atai Life Sciences AG
Updated with BS and further slides into the trips after a tiny speed bump. Oh then an RS so they can claim they need to get to over a penny for OTCQB... lol
This will lose you all more money while they play this game. So sad.
not a guess lol
This is getting ready for a hard run. the pullback happened over the past month... a few sold off. Lots accumulated between Dec 2022 and into Early July 2023... get ready boys and girls for a fun fill rip! It's coming!
These are just the previews.
Next week will be the same as last...