Rising High: Exclusive talk with biotech company Clearmind Medicine

In this edition of “Rising High,” 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 developing treatments for binge behavior and mental health.

Haden shares his past experience around the early use of MEAI, before the establishment of Clearmind, and events that brought him to the understanding that MEAI has the potential to be an effective treatment for various addictions, including alcoholism. That is why he decided to join Clearmind, a company that is developing a therapeutic use of MEAI through FDA approval. Here are some highlights:

PSYCHEDELIC-DERIVED THERAPEUTICS: Clearmind’s primary objective is to research and develop psychedelic-based compounds for underserved health problems and attempt to commercialize them as regulated medicines, foods or supplements. “Clearmind has been formed around a particular molecule MEAI,” Haden said “And it owns patents around the molecule, which for the psychedelic field is highly unusual. There’s nothing else like it.”

5-Methoxy-2-aminoindane, or MEAI, is a non-hallucinogenic psychoactive molecule that creates a “satiated” or “had enough” feeling preventing overuse while exerting a euphoric alcohol-like experience. Clearmind is presently testing MEAI for the treatment of alcohol use disorder. “MEAI is a remarkable molecule and based on what we know to date, probably has strong anti-addictive effects,” the VP said. “I’ve spent the first two decades of my career working addiction services in Vancouver, Canada. If you look at the other options that are available to people with alcoholism and other addictions – AA, counseling, Naltrexone, Acamprosate and Antabuse – they either take away the pleasure, have limited effectiveness or make you violently ill. It is very rare for anyone to take Antabuse a second time.” In contrast, “MEAI may offer a patient a positive experience with a reduced desire to consume alcoholic beverages,” he said, continuing, “Anecdotal evidence shows it has an abrupt response of people stopping drinking and Clearmind is on the clinical trial pathway, much of the business model is clinical trials.”

SELF-ADMINISTRATION: As competition continues to ramp up in the psychedelics space, the VP noted that Clearmind’s treatment process is very distinct and serves as a key differentiator from others in the field. “I started the Multidisciplinary Association for Psychedelic Studies Canada and ran it for ten years,” he said. “I’m familiar with the psychedelic space and what Clearmind is doing is completely different.” Haden pointed to the high expense of traditional psychedelic treatment due to its intensely therapeutic nature, meaning fees for credentialed staff and real estate. “I’ve done the math and I know what it is going to cost for people to be treated through MAPS,” he said. “I calculated it’s going to be $10,000-$15,000 for two or three treatments.”

However, with Clearmind’s MEAI, a patient suffering with AUD will potentially be able to go to a doctor, get a prescription and take the treatment as prescribed, the VP said. As addiction is a chronic disease, Clearmind is developing MEAI to be accessible just like any other therapeutics designed to treat chronic diseases such as diabetes, high blood pressure, etc. “With all psychedelics, you take it once, twice or three times, but we see our treatment as something you would take every time you wanted to stop your drinking and it wouldn’t involve the cost of therapy.” Haden added that the use of the molecule for several indications is also patented as part of Clearmind’s intellectual property portfolio, which consists of 14 utility patent families, including nine granted patents and 21 pending applications. “Clearmind has a whole patent portfolio to protect itself in every possible way it can,” he said. “If you’re going to spend the expense required to work your way through the clinical trial process, you need to be able to assure possible investors that you are protected.”

MEAI also has self-limiting properties unlike traditional treatments, he said, so a satiation response can be triggered. “It’s like you just finished eating two pieces of chocolate-covered cheesecake and someone puts a third piece of cheesecake in front of you,” the VP said. “You look at that third piece with amazement and you can’t even get close to it. It’s not because you’re so sedated that you’re lying on the floor, or so stimulated that you’re hanging off the ceiling or so violently ill, you’re kneeling in front of the toilet. You’re just completely and absolutely done with cheesecake. You enjoyed the cheesecake and now you are done.” He added the indication for AUD is massive and getting worse, with over 18 million Americans struggling with the condition. “Interest has also been triggered because of the anecdotal evidence in obesity,” Haden said. “At Clearmind, we have done work with both alcoholic and obese rodents, and they become ‘normalized’. We believe that treating both AUD and obesity is a vastly massive opportunity and it’s getting bigger and bigger in the states.”

PHASE I/IIA CMND-100 TRIAL: In March, Clearmind submitted an investigational new drug application to the FDA for approval to initiate its first-in-human Phase I/IIa clinical trial with its MEAI-based CMND-100 in patients suffering from AUD. The primary endpoint of the trial is to find the tolerable dose and characterize the safety and pharmacokinetics/pharmacodynamics of single and repeated doses. In May, the company received Ethics Committee approval for the trial at Israel’s IMCA center. “If you think about turning the molecule into a medicine, you have to have pre-clinical toxicology to prove that it’s safe at least in two species,” the VP said. “Clearmind has done that. Additionally, we have proven that it works in various animal models including in alcoholic and obese models.”

The next step in the FDA process is proving the molecule is safe in humans, he said, followed by proving effectiveness in both small and large populations. “That is the clinical trial pathway,” he said. “You don’t have to prove its effectiveness in rodents, but we have out of interest’s sake. It lets us know we are on the right track because we don’t want to waste shareholders’ money.” Haden said Clearmind is based in Canada and Israel but decided to seek FDA approval as well. “We decided to bag the elephant as it were,” he said. “Obtaining FDA approval is an important landmark in any course of pharmaceutical company.” Additionally in May, the company announced Yale School of Medicine’s Department of Psychiatry as the first U.S.-based clinical site for join the trial. “Yale is huge and the fact that they said ‘yes’ was significant,” the VP said. “They just looked at the science and they said yes. If you get Yale on board, you have huge credibility.”

FDA DRAFT GUIDANCE: The FDA recently published its first draft guidance on clinical trials with psychedelic drugs highlighting fundamental considerations for researchers investigating the use of these drugs for potential treatment of medical conditions, including psychiatric or substance use disorders. “Health Canada and the Canadian space has been bringing together the psychedelic community and talking to us about the clinical trial pathway,” Haden said. “I’m guessing the FDA process is similar, the FDA hasn’t changed the rules, it’s just explaining the rules in detail. What it says is the door is open and you have to follow the rules.”

SCHEDULING: Several psychedelics are listed as Schedule I drugs under the Controlled Substances Act, but the VP said he does not see the scheduling as a barrier to adoption as the public acceptance of psychedelic medicines has been growing linearly. “In fact, the world’s largest psychedelic conference happened last week,” he said, referring to the Psychedelic Science 2023 Conference held in Denver, Colorado. “There were 11,000 attendees.”

Haden noted a poll from the University of California, Berkley Center for the Science of Psychedelics which found more than six out of ten American registered voters support legalizing regulated therapeutic access to psychedelics. “That is a huge threshold that has just been passed,” he said. “At the end of the day, the clinical trial pathway is still the clinical trial pathway,” he said. “You have to follow every single step and it does not really matter what the legal status of the drug is.”

CHALLENGES: When asked about the largest hurdles facing the psychedelic space generally, Haden pointed to the cost associated with traditional treatments as one of the biggest challenges. “The credentialing of the staff as well as the real estate and time required, results in it being relatively inaccessible,” he said. “Most psychedelic treatments will be expensive.”

In addition, insurance providers have not yet stepped up to fund these types of treatments, the VP said. “That is a huge barrier and why Clearmind has differentiated itself as none of those costs apply,” he said.

OPPORTUNITIES: As the psychedelic industry develops and matures, Haden said opportunities lie in the robustness of the data, the effectiveness of the treatments and the cost-effective nature of the space over time. “If insurance companies look at something like post-traumatic stress disorder and people who are off work for years and they do the multi-year analysis, an expensive treatment upfront would over a long period of time be less expensive than paying disability,” he said. “What may happen is insurance companies will do the long-term benefit analysis and decide that it’s worth it. Hopefully they will step up to the plate and fund it, which would then make it accessible.”

The VP added Clearmind is excited to get closer to turning MEAI into a medicine and to develop other molecules in the pathway. “We want to treat AUD first and obesity second,” he said. “Then once you’ve walked the pathway and turned a molecule into medicine for one indication, it’s a lot easier to add indications as safety has already been proven.”

Haden said he believes MEAI could be useful as a binge mitigator and have other impacts outside of alcohol and food. “Cocaine is a very binge-oriented substance, and I would personally like to know if it works for gambling,” he said. “Right now, we’re betting on MEAI so that is what we’re most excited about.”

CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Aleafia Health (ALEAF), Acreage (ACRHF), Atai Life Science (ATAI), Audacious (AUSAF), Aurora Cannabis (ACB), Avant Brands (AVTBF), Awakn Life Sciences (AWKNF), Ayr Wellness (AYRWF), Body and Mind (BMMJ), BZAM (BZAMF), Cannara Biotech (LOVFF), Canopy Growth (CGC), Chicago Atlantic (REFI), Clever Leaves (CLVR), CordovaCann (LVRLF), Cresco Labs (CRLBF), Cronos Group (CRON), Columbia Care (CCHWF), Compass Pathways (CMPS), Curaleaf (CURLF), CURE Pharmaceutical (CURR), CV Sciences (CVSI), Cybin (CYBN), Delic Holdings (DELCF), Delta 9 (DLTNF), Entourage Health (ETRGF), Fire & Flower (FFLWF), Flora Growth (FLGC), General Cannabis (CANN), Greenlane (GNLN), Green Thumb (GTBIF), GrowGeneration (GRWG), Goodness Growth (GDNSF), Hemp (HEMP), HEXO (HEXO), High Tide (HITI), India Globalization Capital (IGC), Indiva (NDVAF), Innovative Industrial Properties (IIPR), InterCure (INCR), IM Cannabis (IMCC), Wellbeing Digital (KONEF), Khiron Life Sciences (KHRNF), Lowell Farms (LOWLF), Lotus Ventures (LTTSF), MediPharm Labs (MEDIF), MedMen (MMNFF), NewLake Capital (NLCP) Organigram (OGI), Planet 13 (PLNHF), Reunion Neuroscience (REUN), Revitalist (RVLWF), RIV Capital (CNPOF), Relmada (RLMD), RYAH Group (RYAHF), Safe Harbor (SHFS), Small Pharma (DMTTF), SNDL (SNDL), Sproutly (SRUTF), Skye Biosciences (SKYE), Stem Holdings (STMH), Sunniva (SNNVF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Tilray (TLRY), Trulieve (TCNNF), Tryp Therapeutics (TRYPF), Verano (VRNOF), Village Farms (VFF), Wesana Health (WSNAF), Zynerba (ZYNE) and 4Front Ventures (FFNTF).