Project Lucy Submits Pre-IND Briefing Package to the FDA; Agrees Q1 Interim Analysis of Swiss Phase 2a Trial of LSD Assisted Therapy for Anxiety Disorders
NEW YORK and BASEL, Switzerland, Nov. 16, 2020 /PRNewswire/ -- MindMed (NEO: MMED), (OTCQB:MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company, has received a positive response on its protocol design for a Phase 2a clinical trial evaluating microdoses of LSD in the treatment of adult ADHD from the Swiss and Dutch health authorities. MindMed has also successfully submitted a pre-IND briefing package to the FDA for its Project Lucy, a potential Phase 2b Efficacy Trial evaluating LSD Assisted Therapy in anxiety disorders. In addition, the company has now reached an agreement with University Hospital Basel Liechti Lab to conduct an interim analysis anticipated in Q1 2021 for its Phase 2a clinical trial of LSD assisted therapy for anxiety disorders currently ongoing in Switzerland.
Microdose LSD Positive Regulatory Response
MindMed's Phase 2a Proof of Concept study evaluating microdoses of LSD for the treatment of Adult ADHD has successfully reached an agreement on the study protocol with both the Swiss and Dutch health authorities. MindMed is working with our site coordinators in Switzerland and the Netherlands on our patient recruitment strategy and will provide updates on recruitment progress in due course. MindMed anticipates dosing to begin in patients in the second half of next year at both of our sites in Basel, Switzerland and Maastricht, Netherlands. MindMed's clinical and technical operation teams are in the process of producing and preparing the GMP LSD material necessary to begin dosing for the Phase 2a commercial drug trial.
J.R. Rahn, MindMed co-founder and co-CEO said: "We are very pleased with the positive response from the Swiss and Dutch regulators on our protocol design evaluating microdoses of LSD for Adult ADHD in our planned Phase 2a trial. Our team has been working diligently to prepare this trial and we are very excited to begin recruitment and plan on dosing ADHD patients in the second half of 2021."
MindMed's microdosing division is now evaluating the potential for additional microdosing technologies as part of our R&D efforts and growing its portfolio of microdose-related clinical trials.
Submission of Pre-IND Briefing Package to the FDA
Swiss Phase 2a Study Interim Analysis
MindMed maintains an exclusive license to this Phase 2 study as part of our license agreement with the University Hospital Basel. More info on the trial can be found here:
SOURCE Mind Medicine (MindMed) Inc.
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