• -A single oral administration of MM120 100 µg met its primary and key secondary endpoints and maintained clinically and statistically significant HAM-A reductions compared to placebo at 12 weeks with a 65% clinical response rate and a 48% clinical remission rate-
• -MindMed also presents two new epidemiology studies quantifying the burden of GAD in the US-
• -APA Annual Meeting, the largest psychiatric gathering in the world, is the first scientific presentation of MM120 Phase 2b data-

NEW YORK / May 04, 2024 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today presented data from MMED008, its Phase 2b study of MM120 (lysergide d-tartrate) in the treatment of GAD in adults. MM120 demonstrated clinically and statistically significant efficacy compared to placebo at its primary week 4 and secondary week 12 timepoints. The study was presented at the APA Annual Meeting, the largest psychiatry-focused scientific meeting in the world, in New York City being held May 4 – 8, 2024.

MM120 demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4, the study’s primary endpoint, and maintained durability of response to week 12. MM120 was administered as a single dose in a monitored clinical setting, with no additional therapeutic intervention, to demonstrate the medication’s effect.

“On behalf of the 20 million people in the US – and millions more worldwide – who are living with GAD, we are incredibly excited for the therapeutic potential that MM120 shows based on its rapid and robust efficacy, durably sustained for 12 weeks after a single dose in this study,” said Daniel R. Karlin, MD, MA, Chief Medical Officer of MindMed, who presented the Phase 2b MM120 study at APA. “Few new treatment options have shown robust activity in GAD, with the last new FDA approval occurring in 2007. We are committed to bringing MM120 to people living with GAD and are excited to move into the next phase of our development program.”

MM120 100µg – the dose with optimal clinical activity observed in the study – demonstrated a 7.7-point improvement over placebo at Week 12 (-21.9 MM120 vs. -14.2 placebo; p<0.003 Cohen’s d=0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to Week 12. Clinical Global Impressions - Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at Week 12 (p<0.004). This clinical activity was rapid, observed as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between Weeks 4 and 12.

In today’s presentation of the Phase 2b study with MM120, investigators presented results from the assessment of several additional secondary endpoints that were pre-specified. One such endpoint was the change from baseline compared to placebo in Montgomery-Åsberg Depression Rating Scale (MADRS) scores, which measures the severity of depression symptoms. Major Depressive Disorder (MDD) and depressive symptoms are common co-morbidities in people with GAD. MADRS score improvements in the 100 µg arm of the study were clinically and statistically significant compared to the placebo group, with a difference of 5.7 points (p≤0.05) at week 4 and a difference of 6.4 points (p≤0.05) at week 12.

In MMED008, MM120 was generally well-tolerated, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day (day 1) and being consistent with the expected acute effects of the study drug. The most common adverse events, with at least 10% incidence on dosing day in the 100µg dose group, included illusion, nausea, headache, hallucination, euphoric mood, anxiety, mydriasis, hyperhidrosis, paresthesia, fatigue, blood pressure increase, abnormal thinking, and altered state of consciousness.

Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and were not provided study-related psychotherapy for the duration of their participation in the study.

“As a clinician and clinical researcher, I applaud the way this study was designed by MindMed to isolate the effect of MM120 by removing confounding variables like additional medications and psychotherapy,” said Reid Robison, MD, Psychiatrist and Chief Clinical Officer at Numinus (TSX:NUMI) who has served as adjunct faculty at the University of Utah for the last 12 years and was a co-author in the MM120 study. “It gives me confidence in the data and the positive results give me hope that this may translate into meaningful benefits for my patients.”

New Data on the Burden of GAD

Two additional studies with new epidemiological data were also presented today by MindMed at the APA meeting. One study strongly supports screening the general population for anxiety as recommended by the US Preventive Services Task Force (USPSTF), indicating that using the clinically validated GAD-7 screening tool would identify about three-fold more people living with anxiety than are currently diagnosed in the US.

The second study compared diagnosed and undiagnosed people with GAD to determine the condition’s relative impact on their lives. This study determined that clinically meaningful impact of GAD was more significant among undiagnosed adults than their diagnosed counterparts. This difference was consistently noted across multiple factors: health-related quality of life, healthcare resource utilization, substantial activity impairment and work productivity loss.

“We are committed to addressing the unmet medical needs of people with brain health disorders and particularly the growing prevalence and dramatic underdiagnosis of GAD,” said Dr. Karlin. “With seven presentations of new epidemiological studies at scientific meetings this spring alone, we hope to augment the understanding of the burden of GAD and the gaps in diagnosis and treatment impacting people living with this debilitating condition.”

About Generalized Anxiety Disorder (GAD)

GAD is a common condition associated with significant impairment that adversely affects millions of people. GAD results in fear, persistent anxiety, and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S. adults, representing around 20 million people, currently suffer from GAD. This underdiagnosed and underserved indication is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007.

About Study MMED008

MMED008 was a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial enrolled 198 participants who were randomized to receive a single administration of MM120 at a dose of 25, 50, 100 or 200 µg or placebo. The full analysis set (FAS) for the trial included 194 participants, those that had at least one valid post-baseline Hamilton Anxiety rating scale (HAM-A) score. Participants enrolled in the trial presented with severe GAD symptoms (average baseline HAM-A scores of approximately 30). The study's main objective was to determine the dose-response relationship of four doses of MM120 versus placebo as measured by the change in HAM-A from baseline to Week 4. The key secondary objective of the study was to determine the dose-response relationship of four doses of MM120 versus placebo as measured by the change in HAM-A from baseline to Week 8. Secondary objectives, measured up to 12 weeks after the single administration, included assessments of anxiety symptoms, safety and tolerability, and other measures of efficacy and quality of life. More information about the trial is available on the MindMed website (mindmed.co) or on clinicaltrials.gov (NCT05407064).

About MM120

Lysergide is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and is exploring its potential applications in other serious brain health disorders.

About MindMed

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.

MindMed trades on NASDAQ under the symbol MNMD.

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding anticipated upcoming milestones, and progress of trials and studies; timing of a potential End-of-Phase-2 meeting with the FDA; timing of the initiation of a potential Phase 3 clinical trial of MM120; the prevalence of undiagnosed GAD patients; and the potential benefits of the Company’s product candidates. There can be no guarantees regarding the results of the potential Phase 3 clinical trial or that, following any such trial, MM120 will receive the necessary regulatory approvals. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, under headings such as “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.