What connects a nocturnal bonfire ritual in the Peruvian rainforest with Wall Street? The potent psychedelic compound N, N-dimethyltryptamine, better known as DMT.
Starting Wednesday, Mind Medicine Inc., a Nasdaq-listed biotech company will launch a clinical research study on DMTalso known as the active ingredient in ayahuasca, an Amazonian hallucinogenic potion.
DMT produces intense alterations of consciousness and deep out-of-body psychedelic experiences.
The compound, which has been used ceremonially for centuries by native tribes from the Amazon basin, is believed to offer outstanding capabilities in the treatment of mental health conditions like depression and anxiety.
MindMed as the company is colloquially known is launching a phase 1 clinical trial on DMT, with an eye set on understanding its safety profile, dosage parameters, pharmacokinetics and pharmacodynamics.
In the phase 1 clinical trial, DMT will be administered intravenously.
MindMeds clinical research program into DMT is a first for any of the few (but rapidly growing) psychedelics companies listed on the major U.S. exchanges.
However, as substantial as the news might sound for a small biotech company like MindMed, the weight of the announcement is not being placed on DMT itself, but on the companys ability to produce an extensive and diversified pipeline of psychedelic molecules, which at this point already includes LSD, MDMA and a proprietary analog of ibogaine called 18-MC.
This continues to show our expansion beyond just the programs we've already got in our development pipeline. It's more evidence of the value of our collaboration with Dr. Liechti and University Hospital Basel, said CEO Rob Barrow in an exclusive interview.
At the core of MindMeds expansion strategy lies a research partnership with the Liechti Lab at University Hospital Basel in Switzerland, an institution with unique expertise and legal leeway in the research of psychedelic molecules.
The new DMT trials will be conducted as an investigator-initiated study by Dr. Liechti, handing the findings exclusively to MindMed.
The exec. said that the new program highlights the companys edge, as it is able to research a wide variety of psychedelic molecules without having to deploy significant efforts on new infrastructure or personnel.
This is really a great case study in how we can be very effective, efficient and timely with assessing a new drug program, Barrow said.
The company is not letting its excitement behind the new program to guide decision-making. Conversely, MindMeds approach into the DMT business is rigorous and evidence-based.
While anecdotal evidence has placed DMT and ayahuasca at the center of attention when discussing the therapeutic potential of psychedelics, the company will use this study as a starting point for assessing its future DMT strategy.
For these reasons MindMed is still cautious not to announce any formal development program to achieve FDA or EMA approval on DMT.
This gives us a jumpstart effectively in terms of understanding the pharmacokinetics and pharmacodynamics, ultimately to craft a development approach for ourselves if we choose to do so, said Barrow.
The study will begin enrolling 30 healthy volunteers for a randomized 5-period crossover, double-blind, placebo-controlled trial.
In the traditional Amazonian setting, ayahuasca is prepared as a mixture of several plants that ... [+] allow DMT to be metabolized by the body.
I think a lot has stagnated on this idea that there's one treatment indication for psychedelics, says Barrow, emphasizing that these molecules have a broad potential beyond just depression and anxiety.
The exec thinks that as the space progresses and science gets more sophisticated with the study of these substances, we may find that the various components that have been historically assumed as essential in psychedelics therapy aren't actually essential to the safety and effectiveness of the molecules.
This could lead to the discovery of new indications and new methods for using the same molecules.
The CEO says his company is not jumping to any assumptions when it comes to the way psychedelics must be administered. In this particular study, DMT is administered intravenously, which also indirectly tests the parameters under which a lot of organizations are claiming you must administer psychedelics.
The more robust we can be, the more different versions of set and setting or treatment administration parameters we can test throughout our studies, the better sense it gives us in terms of how essential those elements are, he said.
While not in liberty to disclose any specifics, Barrow anticipates that the companys DMT program is one in many early-stage clinical investigations into classic psychedelic molecules, to be announced in the near future.
Read more here:
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