MindMed Collaborators Prof. Liechti and Dr. Holze Announce Positive Topline Data from Phase 2 Trial Evaluating LSD in Anxiety Disorders

MindMed, working in collaboration with the University Hospital Basel, presented the positive top-line findings on their trial with LSD for anxiety. The data was shared first at the PSYCH Symposium 2022.

– Results from the investigator-initiated trial, conducted at the University Hospital Basel (UHB), demonstrated the significant, long-lasting beneficial effects of LSD and potential to safely mitigate symptoms of anxiety and depression –

– Data further validates MindMed’s therapeutic approach and supports the clinical development of MM-120 for the treatment of Generalized Anxiety Disorder –

NEW YORK, May 11, 2022 — Mind Medicine (MindMed) Inc (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical-stage biopharmaceutical company developing novel products to treat brain health disorders, today announced that Dr. Friederike Holze and Prof. Matthias Liechti, MindMed collaborators at University Hospital Basel (UHB), have released positive topline data from a Phase 2 investigator-initiated clinical trial evaluating LSD in the treatment of anxiety disorders.

The data demonstrate the significant, rapid, durable, and beneficial effects of LSD and potential to safely mitigate symptoms of anxiety and depression. These findings were presented in an oral presentation at London’s PSYCH symposium on May 11, 2022.

“We are encouraged by the positive data showing that LSD produced rapid, strong and long-lasting reductions in anxiety and depression symptoms up to 16 weeks post treatment compared with placebo,” said Dr. Miri Halperin Wernli, Executive President of MindMed. “This is the first robust study demonstrating significant lasting effects of any psychedelic drug up to 16 weeks compared with placebo.”

Dr. Miri Halperin Wernli continued, “The statistically significant, strong and long-lasting reductions in STAI-G scores combined with similarly rapid and sustained responses in all secondary endpoint measurements are extremely encouraging. These results further support MindMed’s clinical development strategy, and we look forward to leveraging these findings to advance our MM-120 program for the treatment of Generalized Anxiety Disorder.”

Dr. Matthias Liechti, co-primary investigator of the trial, commented, “While psychedelics including LSD have shown beneficial effects on reducing anxiety, there is still a need for a deeper understanding of the mechanisms and the long-lasting effects by which psychedelics exert their therapeutic effects. Thus, we designed a robust, randomized, placebo-controlled clinical trial with a long follow-up period to extend the promising findings of previously conducted smaller, open-label trials. We are extremely encouraged by the results presented today, demonstrating the long-lasting and strong reduction in patients suffering from anxiety. We look forward to reporting additional analyses and further investigating the therapeutic potential of LSD for patients suffering from anxiety disorders.”

Details on the data presentations are provided below:

The presentation, titled “LSD as a Treatment for Anxiety Disorders: New Evidence of Efficacy,” was presented by Dr. Friederike Holze and Prof. Dr. Matthias Liechti, co-primary investigators of the trial and MindMed collaborators at University Hospital Basel (UHB).

Key data and conclusions featured in the PSYCH Symposium presentation include:

• Topline Efficacy Analysis:
  • Primary Endpoint:  LSD treatment resulted in significant and strong reductions of STAI-G scores 16 weeks after treatment in the between-subjects analysis (least square mean (± SE) change from baseline difference = -16.2 (5.8), 95% CI=-27.8 to -4.5, p=0.007).
  • A clinical response (reduction in STAI-G scores ≥30%) was observed in 65% (13/20) patients in the LSD arm and in 9% (2/22) patients in the placebo arm (p=0.003).
  • Effects were maximal 2 weeks after the second LSD session and sustained up to 16 weeks.
  • All secondary endpoint measurements, including the HAM-D-21, BDI, and SCL-90-R, showed similarly rapid and sustained responses consistent with a lasting treatment effect on anxiety, depression, and general psychiatric symptomatology.
  • Acute positive effects or mystical experiences significantly correlated with long-term therapeutic outcomes.
  • LSD was safe and well tolerated: Only one SAE was considered related to treatment and consisted of acute transient anxiety and delusions during an LSD session.

About the Phase 2 Investigator-Initiated Clinical Trial

The investigator-initiated, two-center, clinical trial was a double-blind, placebo-controlled, Phase 2 trial that investigated the safety and efficacy of LSD for the treatment of anxiety disorders. The trial enrolled 46 patients either suffering from anxiety symptoms in life-threatening illnesses or with an anxiety disorder without severe somatic illness. Patients were randomly assigned to 2 sessions with either oral LSD (200 µg) or placebo administration in the first treatment period, followed by a cross-over to the opposite allocation in the second period after 26 weeks and resulting in a trial duration of 52 weeks per patient. The primary efficacy endpoint was reduction in anxiety symptoms 16-weeks after the last LSD or placebo administration. The primary outcome measure was the State Trait Anxiety Inventory (STAI) global score, which is used to assess the severity of anxiety symptoms. Secondary outcome measures included improvements in Hamilton Depression Scale (HAM-D), Beck Depression Index (BDI), and several other major psychiatric symptoms (Symptom-Check-List-90-R) scores. For additional information on this trial see clinicaltrials.gov [NCT03153579].

MindMed supports the UHB Liechti Lab in conducting investigator-initiated trials for LSD and other novel therapies and has exclusive access and rights to the data generated by these studies.