
The compounds have shown positive results in pre-clinical studies.
The compounds have shown positive results in pre-clinical studies.
The Daily Hit is a recap of the top financial news stories for March 14, 2023.
Ascend Increases Revenue in Q4, but Still Not Profitable
New York-based Ascend Wellness Holdings Inc. (CSE: AAWH.U) (OTCQX: AAWH) got leaner and meaner while also expanding its footprint significantly in 2022, but that wasn’t enough to make the company profitable yet. Read more here.
Arkansas Medical Marijuana Sales Surge in First Two Months of 2023
Arkansas medical marijuana patients spent a total of $45.5 million on products in January and February, up 9.6% from the first two months of 2022. The total amount purchased by registered patients in that period was 8,832 pounds. Read more here.
Psychedelic Patent Battle Heats up Between Reunion Neuroscience and Mindset Pharma
Psychedelic clinical research firm Reunion Neuroscience Inc. (NASDAQ: REUN) is taking Mindset Pharma Inc. (OTCQB: MSSTF) to federal court over claims that the company copied its main psychedelic formula and presented it as its own invention while applying for a patent. Read more here.
Politicians at SXSW Suggest Narrow Window for Cannabis Rescheduling
There’s a narrow window for federal cannabis legalization, according to politicians speaking at this year’s SXSW conference in Austin, Texas. During the cannabis track, consultant Andrew DeAngelo challenged his panelists for answers on why federal legalization had not seen any progress. Read more here.
Altopa
Altopa Inc., a company that markets a blender designed to blend cannabis oils into drinks, can’t escape a securities suit alleging it deceived investors. A North Carolina federal judge on Monday found that the bulk of the claims that Altopa misled investors were pled well enough to survive a challenge. Read more here.
Connecticut
Combined sales of recreational and medical cannabis in Connecticut totaled more than $18 million in February, the first full calendar month since the Jan. 10 launch of the legalized sale of recreational marijuana in the state. Read more here.
Psychedelic clinical research firm Reunion Neuroscience Inc. (NASDAQ: REUN) is taking Mindset Pharma Inc. (OTCQB: MSSTF) to federal court over claims that the company copied its main psychedelic formula and presented it as its own invention while applying for a patent.
Reunion filed a lawsuit against Mindset in the U.S. District Court for the District of New Jersey and is seeking to have its Chief Scientific Officer, Nathan Bryson, added as an inventor of the RE104 compound patent.
The company is also making claims for co-ownership of the patent, unfair conduct in the patent application process, and breach of contract.
“Reunion is proud of its inventions to further its mission to improve the lives of patients and families who suffer from depression and other mental health disorders and intends to vigorously protect its intellectual property position to the fullest extent,” it said in a Tuesday morning statement.
Reunion said it had been developing RE104 to treat postpartum depression and other mental health conditions and was given a patent by the U.S. Patent and Trademark Office (PTO) in April 2022, allowing the company the exclusive right to make and sell the composition until 2041. The patent made public the composition of Reunion’s psychedelic compound.
According to court documents, Reunion alleges that Mindset, another clinical psychedelics firm, copied RE-104 after it saw it in the patent approval and presented it as its own invention to the PTO in June, a few months after the Reunion’s chemical composition was made public.
It claims Mindset named two of its employees as co-inventors of RE-104, even though Bryson was the sole inventor, the company said. Reunion accused Mindset of misrepresentation and fraudulently omitted Bryson’s involvement.
Reunion alleges that Mindset “brazenly” told Reunion that it needed a license from Mindset to use the compound. Wanting to avoid litigation, the two sides agreed to meet to resolve the conflict. Reunion also noted in the court documents that the issue was affecting its third-party funding and wanted to resolve the issue so that its funding could move forward.
The filing stated, “The parties orally agreed on the timing, form, and amount of upfront payments, milestone payments, and royalties.”
After the meeting between the two companies, the CEOs shook hands on an agreement, but the case accuses Mindset of later walking back on the deal.
Reunion said it is suing Mindset to protect its intellectual property and hold it liable for purposely hurting the company.
In a statement released shortly after Reunion made the case public on Tuesday, Mindset said that it “disagrees with and denies the allegations set forth by Reunion.”
“The company plans to vigorously defend itself against this lawsuit,” it said.
Reunion requested a variety of remedies from the court. The company wants the inventorship of the Mindset’s patent to be corrected, meaning that the actual inventors of the patent are recognized, and for the director of the PTO to issue a certificate of correction reflecting this change.
Reunion also wants a declaration that states that it co-owns Mindset’s patent and the inventions claimed within it, and a separate declaration that Mindset engaged in conduct that makes the patent legally unenforceable.
The company is also seeking financial compensation such as its lawyers to be paid, damages resulting from Mindset flipping its position after an oral deal was made, and damages for its interference with Reunion’s ability to profit.
In January, Reunion completed an interim analysis of its phase 1 clinical trial of RE104. The trial involved 32 healthy volunteers who were given ascending doses of RE104, with two of eight subjects receiving a placebo in each cohort.
The drug was found to be safe and well tolerated with no severe adverse events, and showed robust and pervasive pharmacodynamic effects with a shorter duration of psychedelic experience compared to psilocybin.
The company said that it identified a dose level at which most participants achieved a “complete mystical experience,” which has been shown to correlate with psychedelic treatment responses in clinical trials of patients with depression, anxiety, and substance use disorder.
Reunion said it had moved to submit the data to the FDA as part of a pre-Investigational New Drug meeting in preparation for phase 2 trial development.
As various psychedelics become part of the discussion about wellness and mental health treatment, with psilocybin generally leading the way, researchers are beginning to work with different synthesized formulations to find a way to make psychedelics less, well, psychedelic.
They want to block the hallucination experience but keep within the psychedelic the natural medicine that helps people with treatment-resistant depression, anxiety, or whatever condition they are seeking to manage.
One preclinical study in January, 2022 used mice to demonstrate how the hallucinatory effect of a psychedelic can be monitored and adjusted—or turned off—where it binds to the serotonin receptor. Researchers designed and tested a new drug, based in part on a study of the active metabolite in psilocybin (psilocin), that would bind to a certain part of the receptor and not create the hallucinatory effect but still help treat depression.
Another group of scientists reported on engineering a water-soluble, non-hallucinogenic, non-toxic analog of ibogaine called tabernanthalog. In tests with lab rats, they were able to neutralize the psychedelic effect, but found that the new analog still promoted neural plasticity, reduced alcohol- and heroin-seeking behavior, and also had antidepressant-like effects.
The hope is that a still-in-the-lab, non-hallucinogenic psychedelic-therapeutic drug, when fully developed, could become a scaled-up pharmaceutical used by a broader range of people looking for the relief they seek from psychedelics, without the unknown and sometimes frightening hallucinatory experience that comes with it.
That’s the upside—a broader appeal. But with this trip-no-more option on the horizon, more answers are needed to understand the true value of the complete therapeutic effect of the whole, hallucinogenic psychedelic experience. Will blocking the hallucinogenic experience make it a better or worse therapeutic?
One article published by the British Psychological Society stated that the brain operates with greater flexibility and interconnectedness under hallucinogens and that the most prominent and intriguing psychological properties of hallucinogens are their ability to produce complex visual hallucinations and ego-disintegration.
Hallucinogens act within the neurobiology of consciousness, and that is indeed a sticky wicket for researchers sorting out ifs, ands, and buts.
Maybe even bad trips are good. A research paper published in the International Journal of Drug Policy found that bad trip narratives may be a potent coping mechanism, opening “fruitful meaning-making” and enabling users to make sense of frightening experiences. “When even bad experiences become good, an important threshold against psychedelic drug use disappears,” the study concluded.
A cognitive scientist at the University of Minnesota, Link Swanson, explained it this way: If normal perception is a kind of ‘controlled hallucination’ where top-down simulation is constrained by bottom-up sensory input, then psychedelic drugs essentially cause perception to be a less controlled hallucination. “Meeting the challenge of predicting and explaining psychedelic drug effects is the ultimate acid test for any unified theory of brain function,” he concluded.
These are big picture observations to be sure, but they are indicative of the importance of the full, hallucinogenic psychedelic experience in understanding the function of the brain, and helping people adjust to the profound new version of their thinking that usually occurs after treatment.
While the debate goes on, psychedelics companies are stepping up the type and variety of their offerings. Mindset Pharma (OTC: MSSTF) is pursuing both directions—analogs of psilocybin with stronger psychedelic experiences, and another analog of psilocybin with a lower, non-hallucinogenic psychedelic experience. “So what we know preclinically is, the stronger the psychedelic effect of the drug, the greater activation of the serotonin receptor,” Joseph Araujo, chief scientific officer and director at Mindset Pharma, told Psychedealia. “Also, what we’ve seen with our lower psychedelic effect family of compounds is that they stay in the body longer.”
With these new non-hallucinogenic drugs, micro-dosing will be a thing of the past, he said. “We need to determine whether there is a benefit of micro-dosing psilocybin,” he said. “There’s lots of anecdotal data that people feel like there’s a benefit, but we don’t have any really good clinical data to know that today.
“Where people are talking about micro-dosing, we think these low or no hallucinogenic psychedelic drugs will be different,” Araujo said. “You won’t need to microdose them. You can take them with a range of doses, and you won’t have a hallucinogenic effect.”
He said that Mindset is going to be focusing some of their work initially on low or non-hallucinogenic psychedelics by looking at cognitive improvements. “There’s some data pre-clinically, and potentially some anecdotal data, that says if you take very low doses of psilocybin, for example, you can improve attention in animals that have a sort of natural attentional impairments. So we’re going to utilize that pathway to try and develop these drugs,” Araujo said. “And because we’re in the medicinal space, we are looking at treating human diseases with an attention deficit component, such as ADHD and potentially Alzheimer’s disease. Ultimately what we’re trying to do is develop these as new medicines and better medicines than the first generation psychedelic drugs.”
Maybe in the search for a non-hallucinatory psychedelic, researchers will revisit an FDA-approved drug that controls the frequency and severity of hallucinations and delusions for Parkinson’s patients, and formulate a novel therapeutic that can turn a trip off when you have had enough.
Whatever they find out in their labs today, and wherever those findings lead them, will be steps toward bringing psychedelic-assisted psychotherapy out to the masses. It promises to be a long, strange trip. “We think at this stage that the hallucinogenic or psychedelic experience, however you want to refer to it, it’s probably going to remain within a clinical environment for the near future,” Araujo said.
Unpack the industry with the daily cannabis newsletter for business leaders.
Unpack the industry with the daily cannabis newsletter for business leaders.