Harnessing the Science of Psychedelic Compounds for the Treatment of Brain and Mental Health Disorders
By: Ayesha Rashid, PhD
Interviewee: Robert Barrow, CEO and Board Director at Mind Medicine (MindMed) Inc
Harnessing the Science of Psychedelic Compounds for the Treatment of Brain and Mental Health Disorders
By: Ayesha Rashid, PhD
Interviewee: Robert Barrow, CEO and Board Director at Mind Medicine (MindMed) Inc
There is a growing interest in the therapeutic potential of psychedelics for the treatment of brain and mental health disorders.
Research in the area of brain and mental health disorders has been increasing in recent years thanks to growing awareness around mental health and neurologic diseases. Research in the field encompasses various aspects of neuroscience, psychology, psychiatry and related disciplines. These areas of research are critical for understanding and addressing mental health disorders by advancing our knowledge of the brain’s functions to guide development of new treatments.
The goal is to improve our understanding of mental health and brain function, develop more effective treatments, reduce the stigma surrounding mental health and ultimately enhance the quality of life for individuals affected by mental health and neurodegenerative conditions.
With increased awareness and diagnoses of mental health conditions, along with increased development and/or exacerbation of mental health disorders during the COVID-19 pandemic, there is a growing need for new, effective treatments in the space.
The potential of psychedelics such as psilocybin (dubbed “magic mushrooms” as the compound is found in certain mushrooms), lysergic acid diethylamide (LSD) and MDMA are being explored for their ability to treat conditions like depression and post-traumatic stress disorder (PTSD).
The therapeutic potential of the psychedelic drug class was first discovered in the 1930s and 1940s with growing evidence for its effectiveness in treating various brain health disorders.
The Psychedelic Class of Drugs
Psychedelics are a class of psychoactive substances that alter perception, mood, consciousness and cognition. These substances often induce altered states of consciousness, sometimes referred to as “psychedelic experiences” or “trips.” Psychedelics have been used for centuries by various cultures for spiritual, religious, therapeutic and recreational purposes.
Xtalks spoke with Robert Barrow, CEO and Board Director at Mind Medicine (MindMed) Inc, a clinical-stage biopharmaceutical company developing novel psychedelic-based medicines to treat brain health disorders.
Mr. Barrow is a pharmaceutical executive and clinical pharmacologist with over a decade of experience leading drug development programs in a variety of disease areas. After joining MindMed as Chief Development Officer (CDO) in January 2021, he was named CEO in June 2021.
Barrow explains how Mind Med was founded in 2019 to develop drugs in the psychedelic class, with a significant revamping of the company occurring in 2021. Since then, MindMed has been growing substantially, making progress in getting compounds in its pipeline into the clinic.
He says the company is focused on “advancing a pipeline of proprietary versions of these historical molecules with a large historical legacy body of evidence, taking them forward through regulatory approval processes, clinical development and ultimately seeking to get them approved by the FDA and other health authorities to market them as pharmaceutical products.”
He says he joined MindMed to build a lean, efficient team in the business. “I think we’ve done a good job of doing this, being able to build out a pipeline, be very bold and rigorous in our research, bold in our aspirations for how these drugs can be developed and get out into the world.”
The timing may also have been opportune, as there has been significant emerging interest in psychedelic-based compounds for brain and mental health conditions.
“All of us who work in the brain health field understand the dire backdrop. It’s a really unfortunate reality, exacerbated even more so by the pandemic and all of the isolation, and many world events that have happened over the past several years have only accelerated the unfortunate reality of the prevalence of mental health disorders.”
— Robert Barrow, CEO and Board Director at Mind Medicine (MindMed) Inc
Paving the Way for Innovation
MindMed’s lead product candidate is a proprietary form of LSD, which was discovered in the 1930s. In the literature, there are dozens of studies showing promising clinical evidence and potential of this drug class and this molecule in particular. But it had been set aside for non-scientific reasons for many decades, Barrow explains.
Research in the area kicked off again in the 2000s and 2010s as the drugs began to be assessed in cancer patients or patients who were suffering from a terminal illness. The responses in those patients were dramatic, with profound changes in anxiety and depression that allowed them to enjoy the last years of their lives in a much better psychological condition.
Earlier this year, the FDA issued the first guidance on the clinical development of psychedelics, which is something that is quite remarkable, says Barrow. “Ten years ago, no one would have envisioned that being a reality.”
Growing research in the area along with a more accepting and aware regulatory environment have converged to fuel interest in the clinical development of psychedelic drugs.
Additionally, with interest from both patients and healthcare providers such as psychiatrists and an epidemiological landscape where there is a great need, “it’s really a perfect storm of factors that suggest there is a need for companies to take this on and take these products all the way to patients through the hands of providers,” he says.
MindMed has two lead product candidates, MM-120, which is a proprietary form of LSD that has better pharmaceutical characteristics, which the company is developing for generalized anxiety disorder (GAD). The other is MM-402, which is the R-enantiomer of MDMA (R(-)-MDMA), being developed to treat core symptoms of autism spectrum disorder, which are characterized by social and communication deficits. Both compounds are serotonin agonists, particularly the LSD-based MM-120.
Earlier this year, the company partnered with an organization called Catalent to use their proprietary Zydis orally disintegrating tablet (ODT) technology with the aim of achieving faster onset, faster release and better absorption of the molecule. The drug is currently being studied in a 200-patient Phase IIB study with results expected by the end of this year. It’s also being investigated in another study for ADHD.
The R-enantiomer of MDMA has a different pharmacology than its twin and because of that activity, there is less stimulant-like action of R(-)-MDMA, but there’s a maintenance or even an enhancement of the pro-social effects.
“I think the juxtaposition of these two programs is also worth highlighting. When you think of psychedelics, you think of a particular use case and that’s how we’re developing MM-120 for GAD patients. They get what we expect will be a perceptual high enough dose that they have perceptual alteration for a day and there seems to be rapid and durable responses with our other programs. And our other approaches though, we’re just using the direct pharmacology of the molecule.”
Gaps and Needs
Barrow says that the need he hears from providers and patients in the psychiatric and mental health space is a need for drugs that produce robust, rapid and durable responses. And in the models that MindMed is pursuing, these are what they hope to deliver.
Currently for autism spectrum disorder, there are no approved treatments that help with the core symptoms of the condition that either enhance social or communication functioning. To be a first-entrant molecule that could treat these symptoms would be game-changing. “That would be hopefully a world-changing kind of opportunity,” says Barrow.
GAD has been largely overlooked for many decades, he says. The last time a drug was first approved for the disorder was in 2004 with Cymbalta. And even before that, it was a disorder that was often overlooked. Treatments for GAD include benzodiazepines, which work acutely but have chronic safety concerns and selective serotonin reuptake inhibitors (SSRIs), which can take many weeks to work. While these drugs do have an impact, they don’t do enough to help patients live a fully psychologically fulfilling life, explains Barrow.
Barrow says the hope and promise, both in anxiety and potentially even depression and other brain health disorders, is that drugs like MM-120 can generate rapid and durable clinical responses after just one or a series of intermittent treatments.
“We hope this will swing the pendulum in the right direction and represent what this drug class can actually do in the world,” says Barrow.
Obstacles, Stigmas and the Future
The psychedelic drug class is still considered Schedule I controlled substances or characterized as having no recognized medical use. This creates a particular burden on conducting research of these molecules, explains Barrow.
One obstacle around psychedelic compounds is administrative and execution-oriented. Additional regulatory approvals in the US for the compounds occur through the Drug Enforcement Agency (DEA), which regulates them. Therefore, in addition to going through the FDA, you also need to get the DEA to sign off on various steps of transferring material, manufacturing material and conducting clinical research studies, explains Barrow.
At MindMed, Barrow says their team has done an excellent job at navigating the regulatory landscape, given the administrative hurdles.
Ultimately, he says, “if these drugs should be approved and marketed, there’s a very prescribed process where those drugs could be rescheduled and would likely be rescheduled so that there would be a lesser burden and at that point, of course, be a recognized medical use.”
Stigmas surrounding psychedelic compounds have been prevalent for decades, largely due to various historical, social and cultural factors. These stigmas have shaped public perception and government and regulatory policies related to psychedelics.
Companies like MindMed face these challenges by focusing on the science.
“We need to follow the science and evidence we’ve seen with other drugs. It shouldn’t be lost on us that many of the psychiatry drugs we have alter an individual’s perception,” explains Barrow.
Drugs like ketamine and S-ketamine, like Janssen’s Spravato (esketamine) which is now approved for treatment-resistant depression, to antipsychotics to any drugs that are widely prescribed for ADHD, are all drugs that have a pronounced effect on mental perception and consciousness in general. If these are accepted, the goal is that the evidence for psychedelic-based compounds should follow the same path given their promise.
“The science is going to lead us, and ultimately we believe that we’ll win the day,” says Barrow.
ABOUT Robert Barrow
Mr. Barrow is an accomplished pharmaceutical executive and clinical pharmacologist with over a decade of experience leading drug development programs in a variety of disease areas. After joining MindMed as Chief Development Officer in January 2021, he was named CEO in June 2021.
Mr. Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs. Prior to joining Usona, Mr. Barrow served as Chief Operating Officer of Olatec Therapeutics, LLC, a private, clinical-stage biopharmaceutical company, where he oversaw the execution of numerous early- and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease. In addition, he has been responsible for the design and execution of preclinical research programs for new molecular entity drugs in CNS conditions such as multiple sclerosis, Alzheimer’s Disease and Parkinson’s Disease.
Mr. Barrow has also served as both a technical and business adviser to numerous pharmaceutical organizations ranging from startups to Fortune 500 companies.
Mr. Barrow holds a Masters degree in Pharmacology from The Ohio State University and a Bachelor of Science degree from Wake Forest University, where he graduated summa cum laude and is a CFA charterholder.