In this edition of “Psychedelic”, The Fly conducted an exclusive interview with Mark Haden, vice president of business development at Clearmind Medicine (CMND), a psychedelic pharmaceutical biotech company focused on development of therapeutics to solve underserved health problems. Here are some highlights:
PSYCHEDELIC PHARMA: Clearmind is a clinical-stage biotech company that aims to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. The company has been working on treatments for binge behavior and mental health, including alcohol use disorder, binge eating and depression.
“Think of this space as being two overlapping circles, a Venn diagram,” Haden said. “There are addiction treatments, like counseling, Alcoholics Anonymous and some pharmaceutical interventions like Antabuse, naltrexone and acamprosate. I ran an addictions treatment program for 28 years and I can assure you that there is relatively low efficacy, the dropout rate is high, and the treatments tend to be very long-term. That’s the first circle.”
The second circle contains psychedelic treatments, which have generated a huge amount of excitement, he said, but have faced challenges due to the treatments being offered in the context of therapy. “That means it’s expensive, having credentialed people and facility space means high cost,” the VP said. “MEAI, which is the product that Clearmind is working most proactively with, is different from regular counseling and pharmaceutical interventions. If you think about them as not being very effective, having a high dropout rate and long-term treatment, MEAI is the opposite. We believe that it will prove to be very effective, and it is mildly euphoric, so it is the opposite of Antabuse. It is attractive to take so we believe the dropout rate will be very close to zero. It is also quick and short-acting, so we believe we are well-positioned to compete with existing addiction treatments. We also believe we are well-positioned to compete with psychedelic treatments because MEAI has no therapy, so all the cost of therapy and facilities don’t apply.”
MEAI: MEAI, or 5-Methoxy-2-aminoindane, is Clearmind’s flagship proprietary molecule for the treatment of addiction. The non-hallucinogenic psychoactive molecule has exerted a reduced desire to consume alcoholic beverages with a euphoric alcohol-like experience in recreational use. Pre-clinical trials for MEAI demonstrated a high safety profile in addition to a significant and immediate reduction effect on alcohol consumption.
“You can take MEAI if you are addicted to alcohol and you don’t want to stop,” Haden said. “You can add MEAI to your alcohol and we believe it will result in people drinking less. It can be used as an alcohol additive, or an alcohol substitute and it is mildly euphoric.”
He added Clearmind believes if a person drinks MEAI with alcohol, they will consume way less alcohol than they would without MEAI and that is why the company is currently focused on Alcohol Use Disorder.
“It’s interesting looking at intellectual property patents, because there are different kinds of patents out there,” the VP said. “There are patents that I would describe as patent illusions. Any company can put psilocybin in a pill, add a little bit of vitamin C, make it purple and then patent that, but it’s not real because some other company can make a psilocybin pill orange and add vitamin D to it. With Clearmind, we have a very strong IP portfolio, 19 patent families and 31 granted patents. These patents are for specific uses of specific molecules widely covering a broad range of things from binge behaviors to eating disorder behaviors to novel alcohol substitution behaviors and they are real patents as opposed to illusions.”
CMND-100 TRIAL: Clearmind announced in March that it initiated its Phase I/IIa clinical trial investigating the safety, tolerability and full pharmacokinetic profile of its proprietary MEAI-based oral drug candidate, CMND-100, in AUD patients. The study will also include preliminary efficacy evaluations, examining the drug’s potential to reduce alcohol cravings and consumption. IMCA Center in Israel, Yale School of Medicine’s Department of Psychiatry and Johns Hopkins University School of Medicine will conduct the trial.
“CMND-100 is the MEAI pill essentially,” Haden said. “Phase I is safety and Phase IIa is with the target population of alcoholics. The Phase IIa is a randomized, double-blind placebo trial, which is the state-of-the-art process for turning a molecule into a medicine.”
DR. GLITTER: In December, the company announced a non-binding term sheet with Dr. Glitter. The two companies are collaborating on the development and commercialization of Clearmind’s MEAI-based alcohol substitute and Dr Glitter’s proprietary ActivCrystal technology, an oral delivery format that encapsulates active ingredients in crystals designed to be sprinkled on meals.
“Dr. Glitter is a company that has a sparkly product that they put on food,” Haden said. “It is a sprinkle product, and we reached out to them because we would like to have this experience available to people. If we can move ahead and expand this, then what it can provide us with is a revenue stream by which we can do all our clinical trial research. It also allows people to experience this and for us to gather more data about what people think about this product.”
SCHEDULING: Several psychedelics are listed as Schedule I drugs under the Controlled Substances Act and the VP said he expects this to initially create a barrier to widespread acceptance of psychedelics.
“What companies need to do is go through the clinical trial research process, the process of turning a molecule into a medicine, Stage I, II and III,” he said. “The clinical trial research pathway is very much alive and well.”
Haden noted he recently did a search on Clinicaltrials.gov, which lists all clinical trials around the world, for the word ‘psychedelic’ and results came back for 658 active clinical trials.
“If you search MDMA, ketamine, PCP or whatever else, then you would wind up with many other hits, but for the word psychedelic alone you have 658,” he said. “What that tells you is there is a massive research interest and some of those are companies that are very interested in turning molecules into medicines for specific conditions. The engine of research is chugging down the track dramatically and eventually when drugs become approved by Health Canada or the FDA and get turned into medicine, then their scheduling will be changed.”
ELECTION RESULTS: In this year’s U.S. election, Massachusetts voters rejected a ballot measure that proposed decriminalization of psychedelic use for people older than 21 and the VP said he believes the legalization process for psychedelics will be similar to the process for cannabis.
“Cannabis is fully legal all across Canada and that was preceded by a process where some provinces wanted it and some didn’t,” he said. “It was a mixed bag and eventually our federal leadership said we need to do this for the whole country. You see the same thing in the U.S. now, some states have varying degrees of cannabis legalization and some states don’t. My crystal ball gazing says sooner or later the United States will fully legalize cannabis. It is a linear process, and some states are more behind than others, which is also completely true for psychedelics.”
Haden pointed to Oregon and Colorado as states that currently have legal psychedelic services and treatment centers and said from a public health point of view, the state-by-state differences are actually ideal.
“When you have different laws in different states, you can then look at different outcomes,” he said. “It is a really good way of doing public health analysis. If you have large populations that have different laws and you can look at hospitalizations and other health indicators in different states, you can come up with some interesting observations of the harms or benefits of psychedelics. Generally, I think that is a good thing and it doesn’t stop the overall collective agreement that psychedelics could be very, very useful.”
The VP also noted that when cannabis was becoming legalized in the states and in Canada, human rights arguments didn’t work in facilitating legalization.
“‘I have a right to access cannabis, and you shouldn’t criminalize me for doing so’ was not an argument that worked,” he said. “What worked as an argument is ‘This is a medicine for my child’. When moms started showing up and saying, ‘I want this medicine for my child that has seizures’ that shifted the opinion. Medicalizing cannabis does promote legalization, and we are medicalizing psychedelics in the same way.”
Also in this year’s election, Donald Trump was elected president and Haden said Clearmind is optimistic that the administration will be helpful for psychedelic research.
“Trump and his administration are a little hard to predict on all issues,” he said. “There is a built-in chaos to that question, but nevertheless what we can see is they are generally anti-regulation. That is good for us because it is the regulation, the huge number of steps and the cost that impacts us and slows us down. And Robert F. Kennedy Jr., the secretary of Health and Human Services, has stated that he supports psychedelic therapy and research, so we are optimistic.”
AT-HOME TREATMENTS: According to industry sources in the psychedelic space, the demand for at-home treatments should accelerate innovation in non-invasive therapeutic options in 2025 and the VP said MEAI is well-positioned for this demand.
“The difference between at-home and in-clinic treatments is at-home treatments are cheaper,” he said. “When you are talking about MDMA or psilocybin therapy, what you are talking about is credentialled staff, facilities, heating costs, real estate costs, and reception costs. The moment you take it out of a facility, and you offer it as an at-home service you make it more accessible, but then you must be careful about what you’re making accessible.”
MEAI is the “perfect” molecule, Haden stated, because it is not abusable and it can be taken home.
“The idea is that it isn’t offered within the context of therapy, it’s offered just as a prescription pill that you take when you feel like drinking,” he said. “You take it with your alcohol or by itself and it doesn’t need therapy or medical supervision. It increases accessibility, it’s inexpensive and it is available to people in a way that therapeutic interventions wouldn’t be.”
CHALLENGES: When asked about the largest hurdles facing the psychedelic space, the VP pointed to the cost of clinical trials, the need to train physicians and therapists and insurance coverage for these treatments.
“Clinical trials cost millions and the constant need to be fundraising is a significant barrier,” he said. “It takes time, energy and effort to do that fundraising. If you look at the companies that are currently doing psychedelic research, they tend not to be big pharma companies that have deep pockets, but independent companies that are focused exclusively on psychedelics. They don’t have a lot of other income streams that they can feed into their clinical trial pathway. My belief is that that will change and the large pharma, when they see the success of the smaller companies, will essentially purchase them.”
Haden also said physicians and therapists must be knowledgeable about how these treatments work and understand how to prescribe them.
“It’s a very, very specific type of therapy,” he said. “Someone who does cognitive behavioral therapy or family systems therapy, those therapies aren’t appropriate for psychedelic therapy. It is a unique skill set where you have to train therapists to do something different. In fact, often they have a lot of unlearning to do so they don’t do what they have historically done. That takes time, energy, effort and commitment of therapists who pay for that training to adopt new models of working.”
Insurance creates another barrier as insurance companies need to see the treatments and understand the efficacy of them, the VP said, as well as how they tend to be brief but intense therapy.
“They are more expensive initially but then a lot cheaper in the long-run,” he said. “Insurance companies do need to be able to see the large picture of how psychedelic therapies will help them and reduce their overall costs. That requires some education of the insurance companies.”
OPPORTUNITIES: As the psychedelic industry develops and matures, Haden said he expects small psychedelic companies to continue to grow, conduct research and demonstrate effectiveness.
“I believe the FDA will become slowly friendlier and allow more psychedelic applications over the next few years and more psychedelics to be turned into medicine,” he said. “Health Canada will do the same. It’s a process of legitimizing psychedelic research with the regulators. What will happen is, slowly but surely, different molecules will be turned into medicines, small companies will do well financially, they will be taken over by large pharmaceutical companies and then the deep pockets of the pharmaceutical industry can speed up the process dramatically.”
Looking at Clearmind specifically, the VP said the company is continuing the track for treating addictions and obsessive-compulsive disorders but is also on track for its alcohol substitution initiative.
“MEAI actually feels good, it is a pleasant experience,” he said. “Having MEAI in a bottle or a can as a drink that people can reach out for and drink instead of drinking alcohol is another way of thinking about the molecule. We’re excited by both tracks, and we are hopeful that these things will become widely available in the not-too-distant future.”
OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Clearmind (CMND), Compass Pathways (CMPS), Cybin (CYBN), Entheon Biomedical (ENTBF), Filament Health (FLHLF), GH research (GHRS), Incannex Healthcare (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla Biotech (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX).
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