MindMed has commenced a study for its “LSD neutralizer technology,” which it hopes will be effective in shortening and even stopping the effects of an LSD trip during LSD assisted therapy sessions.
In collaboration with the Liechti Lab at University Hospital Basel, a Phase 1 clinical trial will evaluate the effect of ketanserin for this purpose.
MindMed hopes the study will be completed by the end of 2021.
Ketanserin: a 5-HT2A Antagonist
LSD is a serotonergic (or, ‘classic’) psychedelic, which binds to the 5-HT2A receptor. As such, it is understood to be a 5-HT2A agonist.
Ketanserin, meanwhile, is a 5-HT2A antagonist, and has been shown to remove most of the acute effects of LSD if administered prior to the administration of LSD (one such trial was conducted at University Hospital Basel itself; see also Section 6 of Canal, 2019 and Preller et al., 2017 for further information on Ketanserin and LSD).
Now, MindMed seeks to go beyond this pretreatment effect of ketanserin and explore whether the same effect can be reproduced after LSD has already been administered, to see if ketanserin can still mitigate the subjective effects of LSD when the psychedelic experience is in full swing.
Ketanserin itself with discovered by Janssen Pharmaceuticals (owned by J&J) in 1980. However, MindMed hopes that this study will support its patent application filed in 2020 which intends to cover its application as a neutralizer technology during LSD therapy.
Possible, patentable, profitable?
Whether this application of ketanserin will be effective, patentable, and profitable is yet to be seen.
Psychedelics researcher Matt Baggott points out that “stopping an LSD trip with a 5-HT2AR antagonist might be harder than stopping trips from other psychedelics.” Baggott goes onto explain, “when LSD binds to 5-HT2AR, it seems to pull part of the receptor down, forming a lid.” While this may help to explain the length of an LSD trip, it could also make ketanserin posttreatment ineffective.
A broader discussion that this technology touches upon is whether a bad trip is something to be mitigated or confronted. For an interesting cultural history of the ‘bad trip,’ Erika Dyck and Chris Elcock’s article in The Social History of Alcohol and Drugs is worth a read.
It is also yet to be seen whether patent examiners will deem this a novel technology.
Full News Release…
Potential Emergency Off-Switch for Psychedelic Assisted Therapies
BASEL, Switzerland, Feb. 17, 2021 /CNW/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company, announced the start of a study for its LSD neutralizer technology intended to shorten and stop the effects of an LSD trip during a therapy session. This discovery, when further developed, may act as an emergency ‘off-switch’ for psychedelic assisted therapies.
MindMed is working in collaboration with University Hospital Basel’s Liechti Lab on the Phase 1 double-blind, placebo-controlled, random-order 2-period crossover design clinical trial evaluating the effect of ketanserin on the acute response to LSD in healthy subjects after LSD administration. The study is being conducted at the University Hospital Basel Liechti Lab and is expected to be completed by year-end.
MindMed is actively pursuing the development of LSD assisted therapies through its Project Lucy, including a Phase 2b trial for anxiety disorders planned to be conducted fully through the FDA pathway. As a result of focusing on LSD assisted therapies, MindMed is looking to innovate additional features that can make its experiential therapies most suitable for a therapeutic setting and thereby create the best possible patient journey and experience.
Dr Matthias Liechti commented, “Based on preclinical and ongoing clinical research we expect highly relevant results from this proof of concept study in healthy subjects. If working as expected and fully developed, the approach would allow treatment of patients with LSD while having an option to end an experience if considered necessary by the patient or therapist. Such a technique will further increase the safety of using LSD in a therapeutic setting and will provide a tool for reducing and ending psychedelic experiences induced by LSD or possibly other psychedelics.”
LSD is thought to induce its prototypical psychedelic effects primarily via stimulation of the serotonin 5-HT2A receptor. As shown in studies in healthy volunteers, administration of the 5-HT2A receptor antagonist ketanserin prior to the administration of LSD almost completely prevents the acute effects of LSD. However, it is not clear whether an LSD experience can also be attenuated and shortened using ketanserin administration after the LSD administration, once the psychedelic effects have fully established.
The study hypothesis is that ketanserin (40 mg), administered to healthy humans one hour after taking LSD, significantly shortens and reduces the acute subjective effects of the LSD (100 μg) compared to LSD alone (100 μg) followed by a placebo. Such a finding would confirm a primarily competitive antagonism of ketanserin and LSD at the 5-HT2A receptor in vivo and indicate that LSD produces its psychedelic effects only when present at the receptor and that the LSD-receptor interaction can be reversed pharmacologically and relatively rapidly. Ketanserin was discovered at Janssen Pharmaceuticals in 1980 and has been actively marketed as an antihypertensive agent. This study will support the patent application that was filed last year (preserving all worldwide rights) for a neutralizer technology intended to shorten and stop the effects of an LSD trip during a therapy session.
MindMed Executive President Dr. Miri Halperin Wernli said “One of the many fears and stigmas associated with psychedelics are rare happenings of ‘bad trips’. We are seeking to equip therapists and other medical professionals with the resources and technology to better control the effects of dosing LSD, and other 5-HT2A agonists such as psilocybin, in a clinical setting to improve the patient experience and outcomes. This advancement could pave the way for greater therapeutic applications of LSD to really allow our brain to reach states of complexity beyond that which it has ever experienced in normal daily life. We believe that this technology, when further developed, could in the future be marketed as an added feature to shorten a therapy session and stop a session if it is so chosen by the patient or the therapist. With this additional potential ‘freedom to operate’ known to the patient, it may enable the brain to function in a way beyond what anatomy usually allows.”
MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company’s groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.
MindMed trades on the Canadian exchange NEO under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ. For more information:www.mindmed.co
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SOURCE Mind Medicine (MindMed) Inc.