RESEARCH | +80 articles

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FDA approves trial of optimized form of LSD, MM-120, for Generalized Anxiety Disorder

by Patrick Ryan | The Dales Report | 25 Jan 2022

The FDA has approved the use of MindMed’s MM-120 to treat generalized anxiety disorder. This is important news for psychedelic investors as MindMed is a publicly traded company with the symbol of MNMD on the NASDAQ. MindMed also trades on the NEO exchange under the symbol of MMED. The hope is that MindMed’s MM-120 will help the clinical stage biopharma business treat individuals saddled by brain disorders and other pathologies.​

Announcement Details​

The FDA’s approval of MindMed’s IND application, short for investigational new drug, will set the stage for the use of the business’s phase 2 MM-120 trial. This is a dose-optimized trial designed to treat general anxiety disorder, often referred to with the acronym of GAD.

The clinical hold applied to the IND was officially lifted this past week after the company responded to requests for additional information regarding monitoring protocols for patients during the ensuing study. MindMed is now working hand-in-hand with the study’s investigators along with clinical trial sites to fast-track enrollment. If everything goes as planned, the study will commence at the start of ’22.

The clearance provided by the FDA for the second phase of the clinical trial is a significant event for MindMed as well as the overarching psychedelics industry. The trial is important as it is the first-ever commercial analysis of the use of LSD in four decades. The study expands on discussions held with the FDA, providing an opportunity to delve into the mitigation of patient anxiety symptoms after one use of MM-120.

The trial’s results will also help provide clarity in regard to dose selection and the development of strategies for the clinical trials in the all-important third clinical trial. Making the study even more meaningful is the fact that it will enhance the scientific understanding of the clinical impact of MindMed’s MM-120 along with the drug’s underlying qualities.​

MindMed’s Statement​

The Chief Executive Officer and Director of the company, Robert Barrow, publicly commented on the announcement. Barrow stated that the clear regulatory path sets the stage for MindMed to gain steam and expedite the trial, ultimately bringing the company that much closer to developing alternative treatment modalities that dramatically alter the landscape of medical treatment for individuals plagued by anxiety.​

Study Details​

MindMed’s study MMED008 is a double-blind, randomized, multicenter, dose-optimized and placebo-controlled phase 2 trial. The trial focuses on patients with GAD, short for generalized anxiety disorder. The trial will focus on 200 individuals provided with one dose of MM-120. Some of the study participants will be provided with a placebo.

The aim of the study is to gauge if the treatment modality reduces anxiety symptoms for upwards of three months after one dose. This dosage level will be compared to that of five unique treatment arms.​

MM-120 Details ​

MM-120 is the company’s proprietary drug. This drug is an optimized form of LSD created to treat brain-based disorders along with GAD. LSD was initially synthesized in the late 30s yet its psychoactive properties were not identified in until the early 40s. Though few know it, psychiatrists used LSD in the 50s and 60s to obtain valuable insight into brain health and facilitate the treatment modality of psychotherapy.

Patrick Ryan

Patrick graduated from Tulane University with degrees in sociology and political science. He also studied economics at Boston University and Tulane University. Patrick holds an ABA-approved paralegal certificate in addition to his undergraduate degrees.

*From the article here :

MindMed Obtains FDA Clearance For The Use Of MM-120

The Food and Drug Administration has approved the use of MindMed’s MM-120 to treat generalized anxiety disorder.

thedalesreport.com

 

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University of Wisconsin-Madison Launches New Psychedelic Research Center

This school offers the first accredited American degree focused on the study and therapeutic development of psychedelic compounds and related psychoactive drugs.

by Emily Jarvie | PSYCHEDELIC SPOTLIGHT | 24 Aug 2021​

Yet another university is focusing its psychedelic research efforts with the creation of a specific center for its work in the evolving space.

The University of Wisconsin-Madison has announced the launch of the UW-Madison Transdisciplinary Center for Research in Psychoactive Substances – a new center that will coordinate its ongoing research and education related to psychedelic compounds.

Under the UW-Madison School of Pharmacy, the center will conduct academic research into the science, history, and cultural impact of psychedelic agents. It will also study the potential therapeutic uses of psychoactive substances, expanding the scope for researchers at UW-Madison to build on clinical studies that have been active at the university since 2014.

The center will also support interdisciplinary educational programs to train scientists, teachers, and practitioners as a partner of the School of Pharmacy’s Master’s Of Science Program in Psychoactive Pharmaceutical Investigation. This school offers the first accredited American degree focused on the study and therapeutic development of psychedelic compounds and related psychoactive drugs.

UW-Madison is currently carrying out four clinical trials with various psychedelic compounds, ranging from Phase 1 to Phase 3, in preparation for submitting applications for new drugs to the Food and Drug Administration (FDA). One study, sponsored by MAPS, is assessing the efficacy of MDMA-assisted psychotherapy compared with psychotherapy and placebo in patients with severe post-traumatic stress disorder (PTSD).

Researchers at the university are also evaluating the efficacy of psilocybin to treat major depressive disorder and opioid use disorder.

“From cannabis to psilocybin and MDMA, psychoactive agents are the new frontier for potential new therapies and medications,” said the center’s founding director and UW-Madison School of Pharmacy Professor Paul Hutson. “In light of the opioid crisis and the ever-increasing mental health needs stemming from the pandemic, the growing list of psychedelic compounds shows tremendous promise in early clinical studies in helping patients with addiction and psychiatric disorders. We plan to be at the forefront of this field with innovation and development of novel therapies through our research and educational programs on psychoactive agents.”

In carrying out its research program, the center also hopes to increase the participation of underrepresented groups in clinical studies. “There is a substantial imbalance in the numbers of black, Hispanic, Asian, and Native American research participants in studies of psilocybin and other psychoactive medications,” Professor Hutson said.

“The center will seek opportunities to improve the representation of minorities, elderly, and marginalized groups in the forthcoming research on psychedelics.”

UW-Madison is the latest in a string of American universities to announce a psychedelics-focused research initiative. In 2019, Johns Hopkins University, which is regarded as the leading psychedelic research institution in the United States, launched the Johns Hopkins Center for Psychedelic and Consciousness Research to expand its psychedelic research.

In February this year, New York University also announced a $10 million psychedelic research and training center, the NYU Langone Center for Psychedelic Medicine. Most recently, in July, Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics revealed it would be launching the first academic initiative focused on psychedelics law and policy, titled the Project on Psychedelics Law and Regulation.​

https://psychedelicspotlight.com/university-of-wisconsin-madison-psychedelic-research-center/​

 

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Massachusetts General Hospital​

Center for the Neuroscience of Psychedelics​

The Center seeks to understand how psychedelics enhance the brain’s capacity for change, to optimize current treatments and create new treatments for mental illness, and to make the term “treatment resistant” obsolete.

Mental illness is the leading cause of disability in developed countries. Fifty percent of Americans experience mental illness in their lifetime and $350 billion is spent annually on treating depression in the U.S. and Europe alone.

Nearly half of that total represents the cost of treatment-resistant patients: those who do not improve despite multiple treatments.

One of the biggest clinical challenges in mental health is treatment resistant patients: those who seek help, but do not improve despite multiple medication and treatment intervention trials.

Treatment resistance reflects both the limitations of our currently available treatments, as well as the likelihood that these patients’ brains are less capable of change in ways that improve mental health.

The Promise of Psychedelic Medicines

Psychedelic compounds—in particular psilocybin, 3,4-methylenedioxymethamphetamine (MDMA) and N,N-Dimethyltryptamine (DMT)—have emerged as promising treatments that may increase the brain’s capacity for change.

Studies suggest that psychedelics may facilitate neuroplasticity at the cellular and network levels allowing the brain to form and reorganize connection.

This creates a unique opportunity to change patterns in brain activity, and in turn, improve symptoms, behavior and functioning, to ultimately eliminate suffering.

There is much to learn about how these psychedelic compounds work in the brain to promote neural plasticity. Initial clinical studies suggest immediate, sustained relief of symptoms after a single administration of a psychedelic compound in a therapeutic setting.

Our Research

Remarkable advances in brain imaging—many pioneered and developed at Mass General—allow scientists the unique opportunity to leverage the world’s most advanced neuroimaging tools and methods to see the neuroplastic effects of psychedelic drugs from neurons to networks.

Seeing and understanding these changes in the brain offers an unprecedented possibility to rapidly transform mental health research and treatment.

The knowledge of how psychedelics promote this sort of change, or neuroplasticity, can be harnessed to complement and even enhance current treatments and alleviate the suffering of those patients in the greatest need of help—and hope.

Comprehensive Interdisciplinary Approach

The Center brings together leaders in psychiatry, chemical neurobiology, and neuroimaging.

Our team of clinicians, clinician scientists, neuroscientists and medical physicists collaborate to investigate the effects of psychedelics at the molecular, cellular and systems levels across different patient populations. Our ultimate goal is to promote healing and alleviate patient suffering.

The Center will leverage Mass General's tradition of excellence, which attracts a global array of stakeholders from academia, industry, and the non-profit world to promote and accelerate collaboration and increase the impact of psychedelic research. The center operates in an extraordinary biomedical and biotech ecosystem that includes Mass General, Harvard Medical School, Harvard University and the Broad Institute along with dozens of biotechnology and biopharmaceutical companies.​

• Department of Psychiatry
  • Mass General's Department of Psychiatry is consistently rated one of the top Psychiatry Departments in the United States per US News and World Report.​
  • It is home to more than 60 specialty clinics and research programs and has the largest clinical research program at Mass General, with studies at the forefront of neuroscience, molecular biology, and genetics.​
• Chemical Neurobiology Laboratory
  • At the cellular and molecular level, Stephen J. Haggarty, PhD, leads efforts in the chemical neurobiology laboratory.​
  • Dr. Haggarty’s group applies precision medicine approaches to understand the molecular and cellular mechanisms of brain plasticity that underlie the beneficial effects of therapeutic psychedelics.​

Current Research

Our foundational research studies aim to understand how psychedelics facilitate changes in brain structure and function, with an initial focus on psilocybin for patients with treatment-resistant depression, and MDMA for patients with treatment-resistant PTSD.

For all studies, we will collect a wide array of neuroimaging data to fully understand the neural correlates of change with psilocybin and MDMA.​

• The Center's first studies explore psilocybin's effect on rumination, a process which contributes to depression, anxiety and other mental illnesses, and the effects of MDMA assisted mindful self-compassion on loneliness in treatment-resistant PTSD, in partnership with MAPS.

Future studies will explore:​

• The effect of psilocybin on cognitive and emotional processing, specifically salience processing and cognitive reappraisal, in patients with treatment resistant depression​
• Psilocybin for personality trait factors that predispose to mental illness​

Our Team​

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Jerrold F. Rosenbaum, MD​

Director, Psychiatrist-in-Chief Emeritus​

Director, Center for Anxiety and Traumatic Stress Disorders​

Dr. Rosenbaum, Stanley Cobb Professor of Psychiatry at Harvard Medical School, chaired the Massachusetts General Hospital Psychiatry Department for 20 years, leading 600 clinicians and researchers, and 150 trainees. The Psychiatry Department was ranked by U.S. News and World Report as #1 in the United States in 2019 and for 20 of the prior 24 years, with 60 specialty clinical and research programs and over 70 million dollars in annual research spending. At Mass General, he served as Chair of the Executive Committee on Research.

He is currently the director of the Center for Neuroscience of Psychedelics to understand how psychedelics change the brain and to explore novel mechanisms for treatment of psychiatric disorders. He co-founded Psy Therapeutics to advance the discovery of novel drugs for psychiatric and neurologic disorders and is co-founder of Sensorium Therapeutics, Inc. to explore plant derived molecules as leads for novel psychiatric therapeutics.

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Sharmin Ghaznavi, MD, PhD

Associate Director & Director of Cognitive Neuroscience
Instructor in Psychiatry, Harvard Medical School

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Bruce Rosen, MD, PhD

Scientific Director, Neuroimaging
Director, Athinoula A. Martinos Center for Biomedical Imaging Professor of Radiology, Harvard Medical School

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Stephen J. Haggarty, PhD

Scientific Director, Chemical Neurobiology
Director, Mass General Chemical Neurobiology Laboratory in the Center for Genomic Medicine
Stuart and Suzanne Steele Research Scholar and Associate Professor of Neurology, Harvard Medical School

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Jacob Hooker, PhD

Director, Translational Biomarkers
Professor of Radiology at Harvard Medical School
Phyllis and Jerome Lyle Rappaport MGH Research Scholar at Mass General

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Franklin King, MD

Director of Education and Therapist Training
Instructor in Psychiatry, Harvard Medical School

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Jeremy N. Ruskin, MD

Professor of Medicine, Harvard Medical School
Founder and Director Emeritus, Telemachus & Irene Demoulas Family Foundation Center for Cardiac Arrhythmias and Cardiac Electrophysiology Fellowship Training Program

Center for the Neuroscience of Psychedelics

The Center seeks to understand how psychedelics enhance the brain’s capacity for change, to optimize current treatments and create new treatments for mental illness, and to make the term “treatment resistant” obsolete.

www.massgeneral.org

 

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Center for Psychedelic Research and Therapy launches at Texas University Austin

Dell Medical School at the University of Texas’ Austin campus will now host a Psychedelic Research Centre.

Truffle Report | 17 Dec 2021

Dell Medical School at the University of Texas’ Austin campus will now host a Psychedelic Research Centre, according to a press release issued on Thursday.

Dubbed The Center for Psychedelic Research and Therapy, the newly established institution will examine the potential “for drugs such as psilocybin, MDMA, ibogaine and ayahuasca” to act as treatments under the supervision of trained providers.

Conditions such as PTSD, depression, and anxiety will be the primary indications researched, with care objectives being focused on Texas’ substantial veteran population, the second highest of any U.S. State.

Veteran support organizations The Mission Within and The Heroic Hearts project will act as program partners, helping to organize and encourage psychedelic research with veteran subjects suffering from mental health issues.

This announcement adds Dell Medical to the growing list of academic affiliate psychedelic research centers currently operating in the United States, as the first of its kind in Texas.

“This research will bring further scientific rigor and expertise to study psychedelic therapy,” said center co-lead Charles B. Nemeroff, professor and chair of Dell Med’s Department of Psychiatry and Behavioral Sciences and holder of the Matthew P. Nemeroff Endowed Chair. “Recent studies have demonstrated considerable promise for these drugs when incorporated with clinical support, and this work has the potential to transform how we treat conditions like depression and PTSD, and to identify synergies between these and other well-established therapies to achieve long-term benefits for those seeking treatment.”

Earlier this year, the State of Texas passed a psychedelic research bill put forward by Representative Alex Dominguez initiating the study substances such as psilocybin, MDMA, and ketamine for the treatment of mental health issues in veterans.

The legislation authorized Texas’ Health and Human Services Commission, in collaboration with Baylor College of Medicine and the Veterans Affairs Medical Center, to conduct clinical psychedelic research studies with psilocybin-assisted therapy for treating veteran PTSD. The commission was also directed to carry out a scientific review to evaluate the therapeutic efficacy of the given psychedelic substances and provide quarterly reports.

The post Center for Psychedelic Research and Therapy Launches at Texas University appeared first on Truffle Report.

Center for Psychedelic Research and Therapy Launches at Texas University

Dell Medical School at the University of Texas’ Austin campus will now host a psychedelic research centre, according to a press release issued on Thursday. ...

www.nxtpsychedelics.com

 

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NYU Langone Health establishes Center for Psychedelic Medicine

Philanthropic support of more than $10 million is helping NYU Langone Health advance its already world-renowned reputation in the study of psychedelic medicine. This is being achieved through the establishment of a one-of-a-kind center that will expand research and physician training in this exciting and resurging field.

When fully developed, the NYU Langone Center for Psychedelic Medicine, under the auspices of NYU Langone’s Department of Psychiatry, will support health-focused research across the translational spectrum, from basic science to phase III clinical trials. Principally, it will have three transdisciplinary areas of focus: psychiatry, medicine, and preclinical research.

In addition, a robust training program, the Psychedelic Medicine Research Training Program—which differentiates this center from others—will support the development of early career faculty members and postdoctoral fellows to become independent investigators in the field of psychedelic medicine.

“These initiatives will provide an environment in which scientists, clinicians, trainees, and other staff contribute in meaningful ways to ensure that the momentum created by the modern psychedelic renaissance is sustained and continues to yield medical breakthroughs backed by sound science,” says Michael P. Bogenschutz, MD, professor of psychiatry at NYU Grossman School of Medicine, and an acknowledged leader in the field of psychedelic medicine who will serve as the center’s director.

Leading the way is funding support of $5 million from MindMed, a neuropharmaceutical company pioneering new ways to treat mental health disorders through the advancement of both non-hallucinogenic and hallucinogenic compounds. Specifically, it will help to establish a psychedelic-based training program for clinical investigators skilled in the study of psychedelic-inspired treatments for serious mental health needs. This gift will provide salary support, training, and pilot research funds for four positions (two junior faculty and two postdoctoral fellows) over the course of five years.

The remainder of support to establish the center will come from a $1 million gift from business leader and philanthropist Carey Turnbull, as well as from several seven-figure gifts that he galvanized from his network. He is president of the Heffter Research Institute, one of the country’s leading nonprofit organizations dedicated to supporting studies on hallucinogens like psilocybin for treatment of mental health and other disorders. NYU Langone and the Heffter Institute, through Turnbull’s support, enjoy a long and successful partnership in psychedelic research.

The NYU Langone Center for Psychedelic Medicine will serve as the hub for NYU Langone’s continuing efforts in psychedelics—work that already has garnered international acclaim, and which has been a major force in the field’s successful resurgence. Past and current research focuses principally on the treatment of advanced cancer-related psychiatric and existential distress, addiction, major depression and post-traumatic stress disorder (PTSD).

“Dr. Bogenschutz and Dr. Stephen Ross have assembled outstanding scientific and clinical teams to carry out completed, ongoing and proposed psychedelic-focused studies at NYU Langone Health,” says Charles R. Marmar, MD, the Lucius N. Littauer Professor and Chair of the Department of Psychiatry. “The infrastructure, support, and training opportunities under the auspices of this new center will springboard our psychedelic research efforts to new heights. We are very excited about what the future holds.”

If you are interested in learning more about the center, please visit the Center for Psychedelic Medicine website.

NYU Langone Joins U.S. Health Care Climate Council

NYU Langone becomes the first and only hospital in New York City to join the U.S. Health Care Climate Council. Learn more.

nyulangone.org

 

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Europe’s first psychedelic drug trial firm to open in London

Startup Clerkenwell Health hopes to help make UK a world leader in psychedelics research.

by Linda Geddes | The Guardian | 9 May 2022

Europe’s first commercial facility for psychedelic drug trials is to open in London, with the goal of making the UK a global leader in psychedelics research and innovation.

The British startup Clerkenwell Health aims to begin trials in its central London facility in August, initially focusing on the use of psilocybin to help people deal with the anxiety associated with a diagnosis of terminal illness, and to support them through their end-of-life care.

The news comes as scientists and policymakers gather in London this Wednesday for the Agenda for Psych Symposium, a daylong programme to discuss the latest research and the future of the psychedelics industry in Europe.

Tom McDonald, the CEO at Clerkenwell Health, said: “Psychedelic assisted therapy could be groundbreaking for mental health treatment, and the UK is well placed to be at the vanguard of that as a global leader in clinical trials post-Brexit."

“Our aim is to establish the UK as the heart of the commercial psychedelic research ecosystem, working closely with mental health experts and drug developers around the world to tackle some of the most complex mental health conditions.”

Drug developers are increasingly exploring psychedelic compounds as potential treatments for mental health conditions such as mood disorders, PTSD and addictions, but their status as controlled substances can make it bureaucratically challenging and expensive to progress them through clinical trials.

Conducting these studies in countries such as the UK – where similar trials have already been approved and regulators are more familiar with the safety profiles and potential benefits of these drugs – is one solution. However, foreign companies may need shepherding through UK regulatory processes to avoid unnecessary delays.

This is where specialist clinical research organisations come in: rather than developing one compound or class of compounds for a single condition, Clerkenwell Health will work with multiple drug developers to tackle a range of complex mental health conditions using various psychedelic agents. It will also offer training for therapists who want to work with psychedelic drugs.

Peter Rands, the CEO at Small Pharma, which is trialling the use of dimethyltryptamine (DMT) to treat depression, said: “A set of very specific conditions need to be met to do psychedelic-assisted therapy; it’s quite a specialised area of expertise. The eight or so companies in clinical trials with psychedelic-based medicines heavily rely on contract research organisations to do this kind of research – particularly as they begin to enter [late-stage] clinical trials.”

Prof David Nutt, director of the neuropsychopharmacology unit at Imperial College London and the former chair of the UK’s advisory committee on the misuse of drugs, said: “There is clearly a need to facilitate clinical trials with psychedelic drugs beyond the very few academic centres currently doing this research. So I welcome an external organisation developing the necessary skills and expertise to support companies wanting to invest in these treatments.”

The facility will be based near Harley Street and will initially employ 13 members of staff. The first trials, planned in collaboration with the Toronto-based biotechnology company Psyence, will focus on the use of psilocybin for the treatment of adjustment disorder – an emotional or behavioural reaction to a stressful event in someone’s life – in people with terminal diagnoses.

Clerkenwell Health is also working with the Canada- and US-based companies Mindset Pharma and Mydecine, which focus on treatments for neurological and psychiatric disorders, and psychedelic-assisted psychotherapy for depression and nicotine addiction.

Jessica Riggleman, senior director of clinical and regulatory affairs at Mydecine, said the UK was an attractive place to conduct psychedelic drug trials because of a recently introduced pathway, called the Innovative Licensing and Access Pathway, which aims to reduce the time to market for innovative therapies.

Europe’s first psychedelic drug trial firm to open in London

Startup Clerkenwell Health hopes to help make UK a world leader in psychedelics research

www.theguardian.com

 

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Mount Sinai launches a new Psychedelic Research Center in New York

by Luana Steffen | Intelligent Living

New York’s top private graduate medical school – The Icahn School of Medicine at Mount Sinai – has launched a new center for psychedelics research called the Center for Psychedelic Psychotherapy & Trauma Research. The facility will focus on studying MDMA, psilocybin, and other psychedelic compounds for post-traumatic stress disorder (PTSD), depression, anxiety, and other stress-related conditions.

The institution, led by professor of neuroscience and psychiatry Rachel Yehuda, will first investigate MDMA-assisted psychotherapy for PTSD – a promising treatment currently in advanced stages of Phase 3 trials with FDA approval anticipated over the next 1 – 2 years. Besides MDMA, the Center will study psychedelic-assisted psychotherapy with compounds like psilocybin for trauma-related disturbances.
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People taking MDMA report feelings of introspection, connectedness, compassion towards self and others, empathy, and increased interpersonal trust, which are optimal conditions for engaging in the processing of difficult or traumatic material. It is important that we listen to people’s subjective experiences with these compounds and then study therapeutic possibilities through rigorous clinical trials.​

Mount Sinai’s Center for Psychedelic Psychotherapy & Trauma Research is among the first official research facilities worldwide dedicated to the study of psychedelic medicine. Others include Imperial College London’s Center for Psychedelics Research and Johns Hopkins University’s Center for Psychedelic & Consciousness Research, both facilities were established in 2019.

The Mount Sinai Center will offer more than just clinical trials and research. It will also train clinicians in psychedelic-assisted psychotherapy and serve as an education facility to inform the public as new treatments begin to be clinically deployed over the upcoming years.

Mount Sinai Has A New Psychedelic Research Center In New York

The Center for Psychedelic Psychotherapy & Trauma Research will study MDMA and other psychedelic compounds for PTSD, depression, and anxiety.

www.intelligentliving.co