Mind Medicine MindMed Inc (MNMD) News

Rapid and Durable Response to a Single Dose of MM120 (Lysergide) in Generalized Anxiety Disorder: A Dose-Optimization Study

https://d1io3yog0oux5.cloudfront.net/_8e941dfd4bfcdc0589730491d3305c84/mindmed/db/2265/21484/pdf/MindMed+Psych+Congress+2024+Rapid+and+Durable+Response+to+a+Single+Dose+of+MM120+%28Lysergide%29+in+Generalized+Anxiety+Disorder.pdf



Conclusions

This trial was the first to assess the dose-dependent efficacy of LSD without concurrent psychedelic-assisted therapy. The study demonstrated that, for a single treatment with MM120, 100 µg is the optimal dose to bring forward into future research, as it showed a clinically meaningful and statistically significant improvement in Generalized Anxiety Disorder (GAD) and had a favorable adverse event (AE) profile compared to 200 µg.

This treatment effect was observed as early as the day following treatment (CGI-S) and sustained through the end of the study at week 12. The results support progression toward pivotal trials of MM120 100 µg for the treatment of GAD to confirm efficacy and evaluate the durability of the effect.

MM120 100 µg achieved the highest level of clinical activity at the primary endpoint, with a 7.6-point reduction in Hamilton Anxiety Rating Scale (HAM-A) compared to placebo at week 4. In contrast, the week 4 HAM-A score reductions for 25, 50, and 200 µg were 3.4, 0.9, and 5.5, respectively. The HAM-A score reduction with 100 µg was more than twice that observed in clinical trials for other GAD treatments. Further, at week 4, MM120 100 µg exhibited an effect size of d=0.88, while a meta-analysis of 21 placebo-controlled trials for GAD revealed that current medications provide only modest benefits, with an overall d=0.39.

Comparatively, benzodiazepines have shown acute efficacy in patients with GAD but require repeat dosing to prolong effects and are associated with a risk for dependency and unwelcome side effects.

Additionally, higher doses of MM120 also demonstrated improvement in depressive symptoms. Many patients with GAD have comorbid depressive symptoms; in our study, at week 1, the 100 µg dose showed a placebo-adjusted reduction of 6.6 points in Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline. These improvements had a rapid onset compared to standard-of-care medications for depressive disorders.

MM120 was well tolerated by most participants, with AEs that were primarily mild and temporary, mainly occurring on the dosing day, and were consistent with the drug class and prior studies. There were no serious AEs or suicide-related safety signals.

Functional Unblinding Evaluation of Central Raters in a Large Psychedelic Clinical Trial

https://d1io3yog0oux5.cloudfront.net/_8e941dfd4bfcdc0589730491d3305c84/mindmed/db/2265/21485/pdf/MindMed+Psych+Congress+2024+Functional+Unblinding+Evaluation+of+Central+Raters+in+a+Large+Psychedelic+Clinical+Trial.pdf

Conclusion

This is the first large psychedelic RCT to collect and report data on CR unblinding. The results indicate that utilizing CRs appears to be a viable method for reducing functional unblinding in studies where the investigational product (IP) under study can produce acute subjective effects.

Given the number of active arms in this study, it is possible that future studies assessing CR unblinding may encounter more functional unblinding of CRs if the study includes only one active treatment group versus placebo.

Future studies should continue to assess functional unblinding of CRs, rather than focusing solely on participant and site staff blinding. Additionally, future analysis of unblinded study data should explore the relationship between treatment allocation and CR scoring.

Functional and Sexual Disability, and Quality of Life After One Dose of MM120
(Lysergide) in Adults With Generalized Anxiety Disorder

https://d1io3yog0oux5.cloudfront.net/_8e941dfd4bfcdc0589730491d3305c84/mindmed/db/2265/21486/pdf/MindMed+Psych+Congress+2024+Funcation+and+Sexual+Disability%2C+Quality+of+Life+After+One+Dose+of+MM120+in+Adults+with+Generalized+Anxiety+Disorder.pdf

Nice HOM

Gio you are mistaken... Schedule I drugs that have been used for medical purposes, primarily under strict regulations and often in research settings. For example, cannabis is classified as a Schedule I drug in the U.S. but has been legalized for medical use in many states. Similarly, substances like psilocybin (found in magic mushrooms) and MDMA are being researched for their potential therapeutic benefits, particularly in treating conditions like PTSD and depression.

As for rescheduling, substances can be moved between schedules based on new evidence regarding their safety and medical utility. For instance, in 2020, the Drug Enforcement Administration (DEA) approved the use of a cannabis-derived medication, Epidiolex, which contains CBD and is used to treat certain forms of epilepsy. Other drugs, like ketamine (think Spravato from J&J), have also seen shifts in their scheduling due to recognized medical uses.

The scheduling system is dynamic and can change as more research becomes available and societal views shift.

To be honest it is why I invest here becuase when this happens this stock will be white hot.

hard headed agenda...

And cocaine, heroin and a slew of other drugs are also restricted, yet derivative compounds find their way into prescription meds. FDA has approved these trials. They wouldn't do that if the compound MindMed was developing is banned for medicinal use. Get a clue, loser.

By Law the government has imposed restrictions on psychedelics


it is beyond MindMed's control as they have to act in accordance with U.S. and State law

No matter how wishfull your thinking!

Yes, that's the definition of an FDA approved drug for patient use. Can YOU read?

Can you read?

If it gets approval it will be with medical professionals being in attendance every second of the TRIP .

I.e., no “intervention” by the monitors that is prescribed, standardized, or expected to offer measurable therapeutic value

Except that it does. As evidenced by phase 2 and phase 2b, and the FDA approval for phase 3.

Good reminder in this piece that, while people within psychedelics-savvy communities nitpick about “therapy” vs “support” phrasing, the leading companies all view themselves as operating within a functionally equivalent paradigm

“Other developers, such as Compass Pathways and Cybin, have made similar moves, focusing more on the drug itself rather than combining it with in-depth psychotherapy.”

I.e., no “intervention” by the monitors that is prescribed, standardized, or expected to offer measurable therapeutic value

How did synthetic marijuana get approved? How did all the opioid-based pain killers get approved? How did medical grade cocaine get approved? How did methadone get approved? How did medical methamphetamine get approved? How did ketamine get approved? Etc, etc, etc...

Also, MM120 is an LSD derivative, not 100% LSD. It's a novel compound in FDA trials with FDA Breakthrough Therapy Designation. Do you think the FDA would have even approved the start of the trials if it was a compound that could never be prescribed for patient use? Use your head.

And it's legislation, not legistration, brainlet.

https://www.webmd.com/mental-health/news/20240326/fda-opens-the-door-clinical-use-lsd

The FDA’s breakthrough therapy designation speeds up the development and review of drugs intended to treat a serious condition where early evidence indicates the drug may be better than available therapies. The acceleration of this process may well lead to FDA approval of LSD for treating generalized anxiety disorder within the next few years. That approval would automatically legalize the clinical use of LSD.

Did you read the Massachusetts ballot question? I think not!

Mind med needs legistration , good luck with this!

Here you go:

Is LSD legal?

…

Tufts Medical: https://www.google.com/search?q=Tufts+Medical&rlz=1CABBMB_enUS1125&sourceid=chrome&ie=UTF-8



No, LSD is not legal in the United States. It is classified as a Schedule I drug, and the United Nations also lists it as a Schedule 1 controlled substance. LSD has no appvroed medical uses.
LSD was first synthesized in 1938 by Albert Hofmann, a Swiss chemist. It was studied in the 1950s and 1960s, and was used experimentally to treat schizophrenia and alcoholism. However, its association with the counterculture movement of the 1960s led to its classification as a Schedule I drug in 1968.
Despite its legal restrictions, LSD remains influential in scientific and cultural contexts. Its therapeutic potential has been explored, particularly in treating mental health disorders.

-------------------------------------------
Question 4: Legalizing psychedelic drugs

Our verdict: No

Psychedelic drugs, including psilocybin, DMT, psilocyn, mescaline and ibogaine, are currently illegal both federally and statewide. A “Yes” vote on Question 4 would make them legal at the state level, allowing them to be grown and shared by Massachusetts residents, and clearing the way for the creation of therapy centers where residents could use psychedelics under the guidance of medical professionals. Drugs like psilocybin have been shown to effectively treat a variety of mental health conditions, but much less is known about the other drugs. While the creation of therapy centers would be a step in the right direction, the proposed plan for at-home and personal use comes with very little oversight to ensure users’ safety. Allowing residents to grow psychedelics and share them with anyone is a dangerous proposal, since many of these drugs are associated with life-threatening cardiac problems and long-lasting neurological effects. Given that the therapy centers will be expensive and may take years to open, most residents will likely opt for home use, bringing heightened risks to an already legally fraught issue.

Can LSD break the 20-year drought in anxiety treatment?
As MindMed advances its novel LSD therapy to a Phase 3 trial, the company aims to transform treatment for generalized anxiety disorder.

https://www.drugdiscoverytrends.com/lsd-phase-3-trials-anxiety-treatment-mindmed/

Massachusetts has a ballot question on psycadelics
legalize them
and have them given only with professional health advisors present at all times.
No one will be given psychedelics to take without health providers present.

edit

UP!!

Moving

No just misguided

This has a target of 20.00 and it will be much higher than that when approved.

I'm deep :)

I’ve got 3000 shares all are up at least double now

This is moving up so let’s celebrate that if you are invested you are getting rewarded

Are you trying to imply that I am dense? This is not the cannabis market. To which I will agree with you is an absolute nightmare. This is entirely different. You can't even compare the two.

When dawn breaks on Marblehead you will know.

Good times ahead.

What the hell are you talking about?

Somebody knows something

Sorry meant MindMed... phone autocorrected

Latest interview with Dan Karlin...



https://youtu.be/OPEkoTQXsFo?si=6apnvgyLIzlsywaS

Jack may I respectfully step in here. Mined actually canceled their microdose path. And I agree with them on that.

MM-120 while not a medication like MDMA that is used to enhance therapy. MM-120 will be used in a clinic but therapy is not party of it. Clinicians and therapist are only there for intervention if require. It is not mandatory.

If you dive into the investor deck and look at some of the videos posted you'll see.

I am bullish on them. Not stepping on toes here I hope but it's good to be informed.

I'll post a really good video for your review.

It will be patient use, not physician setting. Wait and see, shortie.

Jack your on the right track but a bit off on some facts. the 2a study was not a sub-perceptual microdose. While anything could happen, I would be surprised if these would ever be prescribed for at home unmonitored use. Reread some of the company materials or trial results to round out your understanding of what mm120 really is.

Ok
you will be a grandmother by that time.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175209525

Look up the cannabis Commishions and how messed up they are.

The politicians set up these commissions so they can appoint their constituents to great paying
jobs. You know votes.

Commisions caught dispenseraries selling moldy medical MJ

How healthy is that?

The drug companies have to pay the commissions for their services.

Cough cough

Live and learn

Good luck

" There is no clinic session or physician monitoring."

Wishful Thinking

Wishfull plan that is already up in smoke as State gov'ts are forming commissions to regulate psychedelics
that will control Mind Medicine practices.

However the Political appoints to the commissions that will be overseeing every hallucinogenic drug in every state

takes precident over development drug companies plans!!!!!!!!!!!!

Do you live in the United States? If you do contact the FDA and your state Health Commishion for the full skinny!

MM120 is a microdose medication that does not produce any auditory, visual or other hallucinations. It would not be required to be taken in a clinic setting under physician supervision. That is false.

LSD (lysergic acid diethylamide), like other Schedule I drugs, could potentially be developed into a medication without full legalization. Currently, LSD is illegal for all uses under Schedule I, meaning it is considered to have a high potential for abuse and no accepted medical use. However, clinical trials are underway to explore its therapeutic potential, particularly for conditions like anxiety, depression, and PTSD.

If these trials prove that LSD is safe (which they are proving) and effective for medical treatment, the FDA could approve a specific formulation of LSD as a prescription drug. In this case, it would still be tightly regulated and only available under medical supervision, such as through specialized clinics or doctors trained in its use. The broader ban on recreational use would likely remain in place, meaning LSD would not be fully legalized, just allowed in controlled, therapeutic contexts.

2026 is 16 months away. I can wait.

MM120 is a dissolving, oral medication prescribed by a doctor or psychologist and taken in the home or any other place the patient wants. There is no clinic session or physician monitoring. It's also not LSD, shrooms or ecstasy in their street drug forms. MM120 is a new molecule that is subject to the same toxicity and side effect testing as any other new medications, and it has already passed that scrutiny or it would not have made it to phase 3. Not sure, other than shorties bashing, why these stupid falsehoods are still being repeated.

I tried to warn MNMD longs as Politicians want more oversight.
LSD is not even going to be legalized.
You will be old people by the time any of these psychedelic clinics will open.


"The law would allow for the cultivation and sale of five types of substances: dimethyltryptamine (DMT), mescaline, ibogaine, psilocybin and psilocyn. The commission would be tasked with defining who is allowed to administer the drugs. The first centers would not open until at least 2026"

I tried to warn MNMD longs as Politicians want more oversight.

Psychedelic drugs have great therapeutic promise. But Question 4 goes too far.
Magic mushrooms and other mind-altering plants clearly have promise as a treatment for some psychiatric conditions.

LOL

9 shares traded @ 5.42 after hours to move the price from $5.24.

what a joke

Jack

You have no power here.

Stop the baloney

you act like a two year old

stop

Lots of douchebags in life

WGAFlying F?

Unbelievable! You’re the one with his panties in a wad.

Go ahead and call me some more names. It’s all you got, Mr. Cool and Collected! LMFAO!

Phase 3 starts soon, loser. Better strap in and tighten up your diapers. Your chicken tendies fund is about to go up if you even have shares.

This is a private web forum. There is no free speech protections here. Your comments can be altered and/or deleted, as well as your account can be removed. This is not a designated public forum. Learn something.