MindMed launches Phase 1 study of potential LSD 'emergency off-switch' ketanserin

Mind Medicine (MindMed) Inc (NEO:MMED) (OTCQB:MMEDF) (FRA:MMQ) announced Wednesday the start of a Phase 1 study for its LSD neutralizer technology, which is designed to shorten and stop the effects of an LSD trip during a therapy session.  

LSD is thought to induce its prototypical psychedelic effects primarily by stimulating the serotonin 5-HT2A receptor. Studies of healthy volunteers have shown that administering ketanserin, a 5-HT2A receptor antagonist, before administering LSD almost completely, prevents the psychedelic drug’s acute effects.  

This LSD neutralizer study is designed to find out if this same result can be achieved when administering ketanserin to patients after they have received LSD, once the psychedelic effects have fully established.

READ: MindMed strikes partnership with Swiss startup MindShift Compounds to develop and patent next-gen psychedelic compounds

The study hypothesis is that ketanserin (40mg), administered to healthy volunteers one hour after taking LSD, significantly shortens and reduces the acute subjective effects of the LSD (100μg) compared to LSD alone, followed by a placebo. Such a finding would confirm a previous in vivo result 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. 

MindMed is working in collaboration with University Hospital Basel’s Liechti Lab on the clinical trial evaluating the effect of ketanserin on the acute response to LSD in healthy subjects after LSD administration. The study is expected to be completed by the end of the year, the company said. 

“Based on preclinical and ongoing clinical research, we expect highly relevant results from this proof of concept study in healthy subjects,” University Hospital Basel leader Matthias Liechti said in a statement. “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.”

Ketanserin was originally discovered at Janssen Pharmaceuticals in 1980 and has been actively marketed as an antihypertensive agent, the company said. 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.

“One of the many fears and stigmas associated with psychedelics are rare happenings of bad trips,” MindMed Executive President Miri Halperin Wernli said. “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.”

The company is also developing LSD-assisted therapies through its Project Lucy program, and its plans include a Phase 2b trial for anxiety disorders planned to be conducted fully through the FDA pathway. Because of the emphasis on LSD, MindMed is working to make its experiential therapies most suitable for a therapeutic setting and thereby create the best possible patient experience, the company said.

That is why ketanserin, which may act as a sort of emergency off switch for psychedelic-assisted therapies, could prove crucial when further developed. 

“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,” Halperin Wernli said. “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.”

Contact Andrew Kessel at [email protected]

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Story by ProactiveInvestors