MindMed's LSD Neutralizer Study Begins
Potential Emergency Off-Switch for Psychedelic Assisted Therapies
BASEL, Switzerland, Feb. 17, 2021 /PRNewswire/ -- 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."