Mind Medicine (MindMed) Inc (NEO:MMED) (OTCQB:MMEDF) said Monday it is collaborating on a Phase 2 clinical trial evaluating LSD for the treatment of cluster headaches at University Hospital Basel's Liechti Lab in Switzerland.
The Phase 2 trial began recruiting patients in early January and has commenced treating patients with LSD (lysergic acid diethylamide), the Reno-based company said in a statement.
MindMed, a leading neuro-pharmaceutical company for psychedelic-inspired medicines, previously formed an ongoing research and development collaboration with the Liechti Lab -- the leading global clinical research laboratory for LSD -- to evaluate multiple therapeutic uses of psychedelics and next-gen psychedelic therapies. Dr Matthias Liechti is serving as principal investigator of the clinical trial.
Cluster headaches are also known as "suicide headaches" due to the severity of the pain caused and often viewed as one of the most profoundly painful conditions known to mankind.
The pain occurs on one side of the head or above an eye and can last for weeks or months. Studies have demonstrated increased suicidality associated with patients experiencing cluster headache attacks.
MindMed said non-clinical and anecdotal evidence suggests LSD can abort attacks and decrease the frequency and intensity of the attacks, adding that there is a need for new treatment approaches as currently available medications often mismanage cluster attack periods.
The company said the Phase 2 trial is investigating the effects of an oral LSD pulse regimen over three weeks in 30 patients suffering from cluster headaches compared with a placebo. The study is a double-blind, randomized, placebo-controlled two-phase cross-over study design.
"As we continue on our mission to discover, develop and deploy psychedelic inspired medicines, we are very encouraged to bring this potential treatment for cluster headaches using LSD out of the shadows and evaluate its efficacy based on clinical research standards with the Liechti Lab," MindMed co-CEO JR Rahn said in a statement.
MindMed said its collaboration will assess if there is clinical evidence for a future commercial drug trial through the US Food and Drug Administration (FDA). Treatments for cluster headaches may potentially qualify for an Orphan Drug Designation and be eligible for certain development incentives that the FDA provides for rare diseases.
Both the Liechti Lab and MindMed intend to learn how they can make the administration of LSD more targeted for cluster headache patients through the Phase 2 trial and future clinical trials.
As part of the collaboration, MindMed noted that it is gaining exclusive, global use of all data and intellectual property generated in the Phase 2 trial.
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