Eleusis, a clinical stage life science company developing the therapeutic potential of serotonin 2A receptor (5-HT2A) agonists, also known as psychedelics, today announced results from their Phase 1 clinical trial of orally administered low doses of Lysergic Acid Diethylamide (LSD). The results, published in Psychopharmacology, include positive data on the safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy older volunteers over a 3-week period. Historically, LSD has been observed to exert clinically relevant therapeutic effects in patients afflicted by depression, anxiety, and substance abuse, and prior research suggests that low dose LSD may have significant potential in treating Alzheimer’s disease. This trial was the first registered modern clinical trial on low doses of LSD.
The publication, “Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Low Dose Lysergic Acid Diethylamide (LSD) in Healthy Volunteers” provides data on a double-blind, placebo-controlled, randomized trial. The trial was conducted in London, England (UK) and enrolled 48 older volunteers (mean age 62.9 years old), who were randomly assigned to four dose groups: 5 µg, 10 µg, 20 µg LSD, and placebo. Each received their assigned dose on six occasions (i.e. every 4 days) over three weeks and had a follow up visit at one month. Safety and tolerability measures included adverse event monitoring, blood pressure, heart rate, ECG measurements, clinical laboratory evaluations, balance, proprioception, cognition, subjective response measures, and psychiatric and physical health exams.
Clinical review revealed no deviations from baseline or abnormalities on either safety or cognitive outcome measures. A minor and expected clinical difference between placebo and active treatment groups was the number of headaches reported. These were described as either mild or moderate in intensity, suggesting that at a sub-perceptual, or microdose level, LSD would not impede day to day activities.
“We are encouraged by the study results,” said Neiloufar Family, the study’s lead investigator and director of research at Eleusis, “which reveal that regular administration of low dose LSD to healthy older volunteers is well-tolerated, and that the frequency of adverse events associated with LSD is similar to placebo.”
“The study provides reassuring safety data,” added Robin Carhart-Harris, head of the Centre for Psychedelic Research at Imperial College London, “and opens the door for larger scale clinical trials to evaluate the potential therapeutic effects of LSD.”
“Our research with serotonin 5-HT2A receptor agonists, such as LSD, suggest that they may represent a new strategy to treat diseases associated with chronic inflammation,” said Charles Nichols, co-author of the study and Professor of Pharmacology at Louisiana State University.
“LSD’s unique polypharmacology may serve to enhance its capacity to simultaneously modulate multiple key pathological processes in the brain associated with Alzheimer’s disease, including neuroinflammation, that are implicated in its progression from mild cognitive impairment.”
“We are excited to share the results of this groundbreaking Phase 1 trial and believe it will serve as the foundation for the promising therapeutic development of LSD and other psychedelic drugs as subperceptual therapeutics.” said Shlomi Raz, Chairman and Founder of Eleusis. “We are committed to unlocking the therapeutic potential of psychedelics at subperceptual, non-psychoactive doses, to safely address the most urgent unmet needs in public health, and look forward to advancing both LSD into Phase II trials for Alzheimer’s disease, and our lead ophthalmology candidate, ELE-02, into trials for retinal disease.”