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VIDEO - Bryan Roth: Understanding Drugs, Understanding the Brain
DARPA Funds $27 Million Project to Create Psychedelic-Inspired Psychiatric Drugs Without the Trip
DARPA - Structure-Guided Drug Design Could Yield Fast-Acting Remedies for Complex Neuropsychiatric Conditions
Focused Pharma program will pursue new drugs that work quickly and deliver lasting remedies for conditions such as chronic depression and post-traumatic stress
In the wake of the Iraq and Afghanistan wars, the mental health crisis among U.S. military veterans remains unrelenting, despite the best efforts of healthcare researchers and providers to confront the scale and scope of the problem. According to a 2018 report from the Department of Veterans Affairs, an average of twenty U.S. veterans commit suicide each day.
To address the acute need for improved treatment options, DARPA today announced Focused Pharma, a program that seeks to revolutionize mental healthcare by developing completely new psychotherapeutic drugs to quickly remedy prevalent neuropsychiatric conditions such as post-traumatic stress, depression, anxiety, and substance abuse. While the neurophysiology underlying these conditions may be distinct, an aspect in common is the presence of a deleterious, repetitive thought process that negatively impacts an individual’s ability to function. For someone with post-traumatic stress, it involves re-experiencing trauma and the feelings associated with it; for depression it can take the form of a recurrent internal editor that attaches negative connotations to normal life events; for addiction it is the preoccupation with acquiring and using the substance of choice.
The goal of the Focused Pharma program is to develop novel compounds that directly affect specific neurotransmitter signaling processes that are often implicated in neurophysiological dysfunction, while overcoming limitations of current approaches. The envisioned drugs would selectively target and bind to specific neurotransmitter receptors, and activate only specific neural signaling pathways that may impact the conditions of interest.
“Focused Pharma will work to develop fast-acting drugs that have lasting impact, going beyond treating the symptoms of mental illness to tackle its underlying neurochemical roots,” said Dr. Tristan McClure-Begley, the DARPA program manager.
At present, psychotherapy, psychopharmacology, and direct brain stimulation are the most effective means of treating the symptoms of neuropsychiatric conditions. While valuable, these approaches also have substantial drawbacks that make them less than ideal for treating a challenge on the scale of mental healthcare for the military community. Existing medications exhibit variable effectiveness from one individual to another, can lead to undesirable side effects, can take weeks to months to observe therapeutic benefits even when paired with counseling, and do nothing to prevent relapse once a patient stops taking them. In the case of psychotherapy and direct brain stimulation, finite availability of treatment makes it difficult to meet high demand over wide areas, and direct brain stimulation requires surgery.
In creating Focused Pharma, DARPA examined evidence from privately funded human clinical studies demonstrating that certain Schedule 1 controlled drugs that engage serotonin receptors show promise of rapid and long-lasting therapeutic effect in treating neuropsychiatric conditions such as chronic alcohol dependence, post-traumatic stress, and treatment-resistant depression following only limited doses. However, because such drugs act on many neurotransmitter receptors and receptor subtypes in the brain without specificity and indiscriminately activate numerous signaling pathways, they produce significant side effects, including hallucination. These effects, coupled with their unpredictable consequences, render the drugs unusable in a military healthcare setting.
Researchers supporting the program will have to address a series of challenges, innovating beyond the state of the art in molecular pharmacology and functional chemical neurophysiology. Additionally, they will be responsible for validating the effectiveness of their compounds in animal models that are robust and accepted as preclinical models. DARPA has scheduled a review at the mid-point of the program to validate the hypothesis that the efficacy of these drugs can be de-coupled from side effects, and will terminate the effort if research does not support that hypothesis. Focused Pharma will not include human clinical trials, but at the end of the scheduled four-year program researchers must have an Investigational New Drug application ready for submission to the U.S. Food and Drug Administration.
“Our fundamental hypothesis is that drugs with biased activation of specific signaling pathways downstream of the receptor may be sufficient to induce a therapeutic effect that is uncoupled from deleterious neurological effects. Recent advances in neurotransmitter receptor structure-guided drug design are allowing us to generate the tools we need to test that hypothesis,” McClure-Begley said. “It is research we need to undertake given the scale of the mental health crisis our veterans face, and if it works, the payoff is a completely new, safe, and effective therapeutic option that transforms complex and previously intractable mental conditions into something more acutely treatable.”
DARPA is hosting a Proposers Day on October 1, 2019, in Arlington, Virginia, to provide additional information about Focused Pharma to interested researchers. Please visit https://go.usa.gov/xVRry for details. The registration deadline is September 24, 2019.
The Broad Agency Announcement includes full program details, as well as instructions on how to submit research abstracts and proposals. It is available at https://go.usa.gov/xVPVZ.
# # #
Media with inquiries should contact DARPA Public Affairs at [email protected]
Associated images posted on www.darpa.mil and video posted at www.youtube.com/darpatv may be reused according to the terms of the DARPA User Agreement, available here: http://go.usa.gov/cuTXR.
Serotonin 5HT2A Receptor Bryan Roth's Research Hamilton's Pharmacopeia Ultra LSD
34 Billion compounds... huge universe of chemical scaffolds.
"We can do it, we are doing it..."
MNMD currently sits at 2.36$ and while I am a huge proponent of psychedelics, the amount of red-tape involved just to get the government to allow companies to conduct studies with these compounds scares me away from investing in such a company.
MNMD may have a bright future but I feel we are still 5-8 years early.
I don't disagree per se, but I do think they are a front runner with the advisory board they have. They have tentacles in everything that matters in the biotech space.
MindMed Announces Appointment of Andreas Krebs and Carol Vallone as Directors and Transition of Bruce Linton
NEW YORK, Sept. 30, 2021 /PRNewswire/ -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ) ("MindMed" or the "Company"), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce that its board of directors has appointed Mr. Andreas Krebs and Ms. Carol Vallone as directors of the Company, effective immediately.
Mr. Krebs is an internationally experienced executive, entrepreneur and best-selling author ("The Illusion of Invincibility"). He heads the family-owned investment company Longfield Invest (Langenfeld/Germany), which focuses on growth companies in various industries as well as in the new economy. He has worked in seven countries, in Latin America, Asia and Canada and as President and Executive Board Member of Wyeth Corporation in the United States. Andreas Krebs was Chairman of the Supervisory Board and Shareholder Council of Merz Pharma, Frankfurt am Main, Germany from 2010 to 2019, is currently a member of the Supervisory Board of the European eye clinic group Veonet (Nordic Capital Group) and holds other board positions across various sectors. Furthermore, he serves as Chairman of the private non-governmental organization, Förderverein Girassol eV, which supports children and young people from socially difficult backgrounds in São Paulo, Brazil.
Ms. Vallone is a well-known business leader, former CEO, and corporate board director, with a strong track record in launching, scaling and selling global companies. Currently, she serves as Chair of the Board of Trustees at McLean Hospital, the #1 ranked freestanding psychiatric hospital and largest psychiatric affiliate of Harvard Medical School; serves on the board of trustees at MGH Institute of Health Professions; and serves on the finance committee at Mass General Brigham. Additionally, Ms. Vallone serves as a board member for the publicly traded Cresco Labs, and for a Bain Capital Double Impact portfolio company, Arosa. She is also an Advisory Director for the investment firm, Berkshire Partners and an Advisory Board Member of the healthcare-focused venture growth firm, Longitude Capital. A serial entrepreneur, Ms. Vallone has served as founder & CEO of global e-learning companies, held manager positions in leading corporate technology companies and served on the boards of public financial services and e-commerce organizations.
Mr. Krebs said, "Mental health issues directly or indirectly impact almost every one of us at some point in our lives. I'm thrilled at the opportunity to help MindMed find better solutions to this huge challenge in the coming years."
Ms. Vallone said, "I feel privileged to support MindMed's esteemed team of scientists and business professionals in the pursuit of new medicines and therapies for those who suffer with mental illness."
Effective September 29, 2021, Mr. Bruce Linton stepped down from the Company's board of directors in order to make room for the appointment of Ms. Vallone and Mr. Krebs. Mr. Linton said, "In a little over two years MindMed has gone from a topic that was frankly difficult to find support for, to attracting world class talent and deep capacity capital." He added further "I am delighted with the candidates joining and look forward to the world of change MindMed can achieve."
MindMed Chair Perry Dellelce said, "We are extremely happy to welcome Carol and Andreas to the Board. The depth of their collective experience with pharma, tech and health-focused organizations, combined with their extensive service on public company boards, will broaden and deepen the capabilities of the Company's board of directors. As well, on behalf of the board of directors I would like to thank Bruce for his committed support and service on the Company's board since the Company's inception. I look forward to working with him on his next ventures."
The appointment of Mr. Krebs and Ms. Vallone is subject to regulatory approval.
MindMed is a clinical-stage psychedelic medicine biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed's approach to developing the next generation of psychedelic-inspired medicines and therapies.
MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.
Carol Vallone moderates "Connecting With Technology" at TIPS 2017
Good video to understand who this person is... very good addition for MindMed
MindMed Expands its Drug Development Pipeline with Launch of R(-)-MDMA Program
NEW YORK, Oct. 26, 2021 /PRNewswire/ -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), (DE: MMQ); the "Company"), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce an expansion of its pipeline with the launch of a program to develop R(-)-MDMA for the treatment of social anxiety and functioning in diagnoses that include Autism Spectrum Disorder (ASD). This program represents a significant expansion and diversification of MindMed's pipeline and furthers the Company's mission to bring innovative products to benefit patients and address unmet medical needs.
Social anxiety and impairments in social functioning are hallmarks of ASD, which occurs in approximately 2% of individuals in the US. At present, there are no approved therapies for the core symptoms of ASD and there remains a significant unmet need for novel therapies to support people with ASD. The economic cost of ASD in the US is predicted to reach $461 billion by 2025, highlighting the need and opportunity for novel interventions. Beyond ASD, approximately 12% of the US general population experience Social Anxiety Disorder at some point in their lives, according to the National Institute of Mental Health.
MDMA, which is a racemic mixture of two structurally unique stereoisomers, R(-) and S(+), is currently in development for the treatment of Post-traumatic Stress Disorder (PTSD), and has demonstrated statistically significant positive results in a pivotal Phase 3 trial. Additionally, in a pilot clinical trial, participants with ASD showed strong and statistically significant improvements in social anxiety and functioning from short-term treatment with MDMA.
The two enantiomers of MDMA each have unique pharmacological activity and preclinical data suggests that the R(-) enantiomer maintains the acute pro-social and empathogenic benefits of racemic MDMA, while demonstrating fewer signs of stimulant activity, neurotoxicity, hyperthermia and abuse liability. This favorable profile suggests that R(-)-MDMA could have applications beyond those of racemic MDMA, including the potential for novel more accessible delivery models and repeat dosing. From a safety perspective, the company has great confidence in the R(-) enantiomer based on its favorable preclinical pharmacology and the extent of prior human dosing of the racemic mixture, which provides valuable insight into the expected safety and tolerability of R(-)-MDMA.
MindMed plans to advance its R(-)-MDMA development program targeting US and EU registration and expects to initiate its first clinical trials in 2022. As a key initial study, MindMed and the Liechti Lab at University Hospital Basel (UHB) plan to initiate a comparative pharmacokinetics and pharmacodynamic clinical trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in 2022. This double blind, placebo-controlled, crossover study will assess differences in acute and lasting effects between MDMA and its two enantiomers in healthy subjects and will provide important data on the optimal treatment model for R(-)-MDMA.
MindMed CEO Robert Barrow said, "The launch of our R(-)-MDMA program represents an important milestone in the continued progress of MindMed and builds on our commitment to developing psychedelics and psychedelic-inspired therapies to treat significant unmet medical needs. The compelling clinical efficacy of MDMA coupled with the unique pharmacological benefits of its R(-) enantiomer suggest that there is an enormous opportunity to bring this second generation psychedelic program to market with the potential for new clinical applications, novel treatment paradigms and enhanced accessibility."
MindMed Chief Medical Officer, Daniel R Karlin, MD, MA, said, "Our ability to enjoy life has a general dependency on feeling connected to other people, sharing experiences, and conveying shared emotions. There are a number of disorders and conditions, and even varieties of non-pathological states, in which individuals find it difficult to convey their own internal experience and emotions. They also may struggle to recognize the routine cues and signals that those around them use to convey emotions. These difficulties themselves can cause cycles of distressing anxiety, and in turn worsen both the sense, and the reality, of interpersonal disconnect. It is our intention with this new program to offer patients new hope for meaningful connection to the millions of people for whom social anxiety and functioning create day-to-day difficulties."
driving after smoking some weed is one thing but driving while tripping just doesn't seem rational. a freeway exit could actually be an hallucination.
'Another Washington City Moves To Decriminalize Psychedelics, With Unanimous Council Vote' -Marijuana Moment Report
12:20 pm ET December 21, 2021 (Benzinga) Print
© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
I didn't read the article because I'm at work, but decriminalization does not make it LEGAL, it just means it's no longer a CRIMINAL offense. Also, would never be legal to drive while on psychedelics.
right, i was just thinking out loud, projecting, if you will. haven't touched any hallucinogenics in over 35 years but when i did that stuff was scary and would never consider driving under the influence of it.
NEWS - MindMed Successfully Completes Phase 1 Clinical Trial of 18-MC
WS PROVIDED BY
Mind Medicine (MindMed) Inc.
Jan 04, 2022, 07:30 ET
- Last subject completed study in late 2021 with topline results expected in early 2022 -
- Results to inform design of Phase 2a study in individuals undergoing supervised opioid withdrawal -
NEW YORK, Jan. 4, 2022 /PRNewswire/ -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the "Company"), a leading biotech company developing psychedelic-derived therapies, today announced the completion of its Phase 1 clinical trial of 18-MC, the Company's non-hallucinogenic proprietary derivative of ibogaine, being developed for the treatment of indications linked to opioid use disorder. The trial was completed in December 2021 with topline results expected in early 2022.
"This is an exciting milestone, and we look forward to announcing the results of our Phase 1 study in the coming months," said Robert Barrow, Chief Executive Officer and Director of MindMed. "The growing opioid crisis claims over 75,000 lives each year and impacts more than we'll ever know. While ibogaine has been used and studied as a treatment for opioid addiction, its efficacy, while promising, has been overshadowed by significant safety concerns. Our proprietary molecule, 18-MC, has indicated an encouraging safety profile and preclinical efficacy data setting the stage for our Phase 2a proof-of-concept study in individuals undergoing opioid withdrawal. We expect to initiate this study in early 2022, which will evaluate the safety, tolerability and efficacy of 18-MC in mitigating the symptoms of opioid withdrawal."
Phase 1 Trial Design
This Phase 1 single and multiple ascending dose trial conducted at a single clinical research site in Perth, Australia, evaluated the safety, tolerability, pharmacokinetics, and effects on cognitive activity of 18-MC in healthy volunteers. Subjects either received doses between 4 and 325 milligrams twice per day (for one day; n=5 per arm) or doses between 2 and 90 milligrams twice per day (for up to 7 days, n=5 per arm).
18-MC is an alpha-3-beta-4 nicotinic receptor antagonist with a differentiated mechanism of action that modulates excessive dopamine fluctuations in the mesolimbic system of the brain. 18-MC is a synthetic organic molecule designed around a coronaridine chemical backbone common to a number of plant-based medicinal compounds, including ibogaine. In preclinical efficacy models, 18-MC has demonstrated strong activity in reducing both withdrawal symptoms and self-administration of opioids, stimulants and other substances of abuse. Extensive preclinical characterization has shown 18-MC to have a strong safety and tolerability profile. Importantly, 18-MC has the potential to overcome safety limitations of ibogaine and has not demonstrated proarrhythmic or neurotoxic activity.
I think we have some IP protection for a while with 18-MC. According to statute, the granting of a pharmaceutical patent includes protection on that patent for a period of 20 years from time of patent filing.
How Long Does a Drug Patent Last?
Drug patents are good for 20 years after the drug's invention. In most cases, this time frame is halved to 10 years after testing finally brings the drug to the marketplace.
Patents are typically awarded within a few years after the patent application submission. A common misconception is that the patent begins only after the drug hits the market. However, the patent protects against copycat drugs from competitors in the pharmaceutical industry even before a drug is available for public use.
Drug Patents and the U.S. Food and Drug Administration
Although patents are good for 20 years after the invention of the drug, it can take up to eight years for a pharmaceutical company to do enough testing for approval from the U.S. Food and Drug Administration (FDA) and investors. This is because the FDA can continuously ask for more studies and experiments that document the side effects and efficacy on human patients.
Due to the rigorous amount of testing that goes into a drug patent, many larger pharmaceutical companies file several patents on the same drug, aiming to extend the 20-year period and block generic competitors from producing the same drug.
Us Patent for 18-MC
Also for the record I invest in this company because they are not recreational. They are a bit deeper than that. They want to create non-hallucinogenic compounds inspired by the science behind the ones that are being decriminalized.
Biotech got destroyed 2021. However, we are in for substantial growth on this one once 18-MC is approved by the FDA.
FDA Clears MindMed IND for MM-120 in Treatment of Generalized Anxiety Disorder
- FDA clearance leads to first commercialINDfor LSD, enabling initiation of Phase 2b dose-optimization trial of MM-120 in early 2022 -
NEWS PROVIDED BY
Mind Medicine (MindMed) Inc.
Jan 25, 2022, 07:30 ET
MNMD), (NEO: MMED), (DE: MMQ) (the "Company"), a clinical-stage biopharmaceutical company developing psychedelic-inspired therapies for the treatment of brain-based disorders, announced today that the U.S. Food and Drug Administration (FDA) has cleared MindMed's Investigational New Drug (IND) application, allowing the Company's Phase 2b dose-optimization trial of MM-120 for the treatment of generalized anxiety disorder (GAD) to proceed.
The previously announced clinical hold on the IND was lifted following MindMed's rapid responses for additional information related to the participant monitoring protocol in the upcoming study. The Company is working with study investigators and clinical trial sites to prepare for participant enrollment, which is expected to start in early 2022.
"FDA clearance of our Phase 2b clinical trial represents a major milestone, for MindMed and for the industry as a whole," said Robert Barrow, Chief Executive Officer and Director of MindMed. "This trial, the first commercial study of LSD in more than 40 years, builds on productive discussions with FDA and provides an opportunity to explore improvements in anxiety symptoms following a single administration of MM-120. Further, the results of this trial will guide the dose selection and development strategy for our pivotal Phase 3 clinical trials, as well as deepen our scientific understanding of the clinical effects of MM-120 and its underlying mechanisms of action."
Mr. Barrow continued, "With a clear regulatory path, we look forward to building on this momentum and advancing this trial as quickly and efficiently as possible, bringing us significantly closer to transforming the treatment landscape for patients who suffer from anxiety."
About Study MMED008
Study MMED008 is a multicenter, randomized, double-blind, placebo-controlled, dose-optimization Phase 2b trial in patients with GAD. The trial plans to enroll a total of 200 participants who will receive a single administration of up to 200 µg of MM-120 or a placebo control. The primary objective of the study is to determine the reduction in anxiety symptoms for up to twelve weeks after a single administration of MM-120, compared across five treatment arms.
About Generalized Anxiety Disorder (GAD)
GAD is a chronic, often debilitating mental health disorder that affects approximately 6% of U.S. adults in their lifetimes. Symptoms of GAD include excessive anxiety and worry that persists for over six months, which can lead to significant impairments in social, occupational and other functioning, according to the National Institute of Mental Health (NIMH). While there is substantial diagnostic overlap between GAD, Major Depressive Disorder (MDD) and other major mental health disorders, there has been very little innovation focused on the treatment of GAD in the past several decades due to the shift in focus from anxiety disorders like GAD toward depressive disorders like MDD, driven by the marketing of serotonin reuptake inhibitors starting in the 1990s.
MM-120 is MindMed's proprietary drug candidate, a pharmacologically optimized form of LSD being developed for GAD and other brain-based disorders. LSD was first synthesized in 1938 and its psychoactive properties were discovered in 1943. From 1949 to 1966, LSD was used by psychiatrists and researchers to gain insights into the world of brain health and to assist psychotherapy. LSD has been investigated for its applications in the treatment of anxiety associated with terminal cancer, alcoholism, opioid use disorder, and depression, among other conditions.
Incredible reversal in effect. This should head north for a little while.
Big News - FDA clearance for commercial LSD trial. New MDMA program launched too.
The PPS has been ridiculously low of late so we can now expect continued surges North.
Video: NEO Spotlight | MindMed