Mind Medicine (MindMed) Inc (OTCQB:MEDF) has officially launched Project Lucy, a commercial drug development program for the treatment of anxiety disorders.
The Reno-based company said it intends to initiate a Phase 2b human efficacy trial that will focus on experiential doses of lysergic acid diethylamide (LSD) administered by a therapist.
MindMed noted that this is the first experiential, psychedelic-assisted therapy to be added to its drug development pipeline.
READ: MindMed adds new principal investigator and Swiss trial site as it expands Phase 2 study of microdosing LSD for adult ADHD
With the launch of Project Lucy, the company said it is now preparing a total of three Phase 2 commercial drug trials based on psychedelic-inspired medicines, making it one of the most advanced and largest drug development pipelines in the psychedelics industry.
"Today's announcement demonstrates our team's strong capabilities to efficiently execute on our vision of building a synergistic platform that can take an idea and turn it into a later stage clinical trial with the sense of urgency investors expect and patients deserve," said Co-Founders and Co-CEOs JR Rahn and Stephen Hurst in a joint statement.
"Having the first-mover advantage on a diverse pipeline of later-stage commercial drug trials in mental health is important for MindMed as a company, but the learnings we obtain from this pipeline also helps us push the frontier of psychedelic-inspired medicines," they added.
As part of MindMed's decision to add an experiential therapy for anxiety disorders to its clinical development pipeline, the company has established a project task force that is preparing a briefing package for a potential Investigational New Drug (IND) with the US Food and Drug Administration (FDA).
MindMed said its Project Lucy task force is working to prepare and analyze data relevant for the discussion with the FDA relating to the potential opening of an IND for the treatment of anxiety disorders.
Previously, the company acquired exclusive, worldwide data rights to eight completed or ongoing clinical trials from the University Hospital Basel evaluating LSD based on over 10 years of research. MindMed said it plans to assemble and use this data as part of its briefing package to the FDA.
MindMed also received the data and worldwide rights to an ongoing Phase 2 trial for anxiety disorders administered by the world leader in psychedelics pharmacology and clinical research, Dr Matthias Liechti, and psychedelic therapy expert, Dr Peter Gasser.
Such data and knowhow will help build MindMed's understanding of LSD for anxiety disorders and its platform for LSD as a prescription medication for serious mental health conditions.
Many mental health disorders appear to be interconnected which presents a unique opportunity to MindMed to innovate and create a novel treatment paradigm. As an example, about 50% of attention deficit hyperactivity disorder (ADHD) patients also suffer from anxiety disorders. Furthermore, up to 90% of patients with General Anxiety Disorder also have symptoms of another mental health problem, such as depression or substance abuse.
The World Health Organization estimates that 284 million people are living with anxiety disorders globally and it is the most common mental illness in the US.
MindMed said it sees a large opportunity to evaluate the interconnectedness of mental health disorders and create a novel treatment paradigm that incorporates both experiential dose psychedelic-assisted therapy and non-hallucinogenic take-home medicines being developed in its microdosing division.
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