MindMed Researchers Unveil Unexpectedly Positive Results from Phase 2 Clinical Trial of LSD in Treating Major Depression

MindMed Inc, a clinical stage biopharmaceutical company developing treatments for brain health disorders, is pleased to announce the positive topline data from a double-blind, investigator-initiated trial evaluating lysergide in the treatment of MDD.

The results of the trial, presented by Prof. Matthias Liechti and Dr. Felix Mueller of University Hospital in Basel and University Hospital of Psychiatry, are a promising step forward in treating depression. On April 14, 2023, the findings were shared in Basel, Switzerland.

The high dose lysergide regimen proved to be a revolutionary treatment for Major Depressive Disorder (MDD). In the study, 28 patients given 100 µg lysergide on the first dosing day, and 200 µg on the second dosing day (separated by four weeks), demonstrated a statistically and clinically significant decrease in Inventory of Depressive Symptomatology (IDS-C) scores 6 weeks after the first administration, when compared to the lower dose regimen of 25 µg for both treatment days.

This decrease was maintained up to 16 weeks after the first administration. Furthermore, the investigational drug was generally well-tolerated, as indicated by the reported adverse events, vital signs, and laboratory values. This data provides evidence of the potential of lysergide to rapidly and durably relieve symptoms of MDD.

The positive results generated by our collaborators at UHB on the clinical activity of lysergide are immensely encouraging! The statistically and clinically significant improvements observed in this study provide further evidence of the clinical potential of lysergide in anxiety, depression, and other brain health disorders.

This is especially relevant to our MM-120 program in generalized anxiety disorder due to the high degree of comorbidity between GAD and MDD. We are grateful to our UHB collaborators for their continued dedication in generating high-quality clinical data which will help further advance our pipeline. Congratulations and thank you to our collaborators at UHB!

Our lab is thrilled with the results of our randomized-controlled trial that examined the benefits of lysergide treatment in MDD. We found that this compound delivered strong, rapid and enduring improvements in patients suffering from depression. To confirm the historical studies, we used a low dose of lysergide as the control.

We look forward to publishing the completed results in a peer-reviewed journal and will continue to explore the therapeutic potential of lysergide and other psychedelics. Prof. Matthias Liechti, co-primary investigator of the trial, commented, “These results are extremely encouraging and we are eager to learn more about the impact of lysergide on mental health.”

About the Phase 2 Investigator-Initiated Clinical Trial

This investigator-initiated clinical trial investigated the safety and efficacy of lysergide for treating 61 patients with major depressive disorder (MDD). Through a double-blind, active-controlled, Phase 2 trial, patients were allocated to either the treatment or active control intervention groups.

Those in the treatment group received 100 μg of lysergide on the first dosing day and 200 μg on the second dosing day, with dosing days separated by approximately 4 weeks, while those in the active control group received 25 μg of lysergide on the first and second dosing days.

Primary efficacy was measured by the clinician-rated Inventory of Depressive Symptomatology (IDS-C) six weeks after the first administration, with secondary outcomes including improvements in the self-rated version of the Inventory of Depressive Symptomatology (IDS-SR), Beck Depression Index (BDI), State-trait anxiety inventory (STAI-G), and other psychiatric symptom assessments. Patients were then followed up for 16 weeks after the first dosing session.

MindMed is proud to partner with the UHB Liechti Lab to conduct cutting-edge investigator-initiated trials for lysergide and other novel therapies. As part of this collaboration, MindMed has exclusive access and rights to the valuable data produced by these studies. With this exciting partnership, MindMed is at the forefront of research for potential new treatments.

About MindMed

MindMed is on a mission to become the global leader in the development and delivery of treatments that improve brain health. Our pioneering biopharmaceutical company is committed to creating novel product candidates to address various brain health disorders.

We are actively pursuing innovative treatments that target key neurotransmitter pathways, both with and without acute perceptual effects, to unlock new opportunities for improved patient outcomes.

MindMed is a publicly traded company, with shares listed on both the NASDAQ and the Canadian NEO Exchange. With a NASDAQ ticker of MNMD and a NEO ticker of MMED, MindMed is a great investment opportunity for those looking to diversify their portfolio.

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