MindMed launches phase 3 LSD study for depression

NEW YORK - Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a biopharmaceutical company focusing on brain health disorders with a market capitalization of $418 million, has begun a Phase 3 study named Emerge to assess the efficacy of its proprietary MM120 Orally Disintegrating Tablet (ODT) in treating Major Depressive Disorder (MDD). The first patient has been dosed in the study, which is anticipated to enroll about 140 participants across the United States. According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 7.25, providing adequate resources for its clinical programs.

Emerge is a 52-week trial divided into two parts. Part A is a 12-week, randomized, double-blind, placebo-controlled study, which will evaluate the safety and effectiveness of a single dose of MM120 ODT against a placebo. The primary endpoint is the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at week six. Following Part A, Part B will offer a 40-week extension period for open-label treatment with MM120 ODT, depending on symptom severity. The stock has shown significant momentum recently, with a 13.5% return over the past week, though InvestingPro analysis indicates the stock’s price movements remain quite volatile.

The MM120 ODT is a pharmaceutically optimized form of lysergide D-tartrate (LSD), acting as a partial agonist at serotonin-2A (5-HT2A) receptors. The formulation uses Catalent’s Zydis ODT technology, which allows for rapid absorption and improved bioavailability, while reducing gastrointestinal side effects.

This Phase 3 study builds upon the positive outcomes of a Phase 2b study in Generalized Anxiety Disorder (GAD), where MM120 demonstrated significant antidepressant effects. The MM120 ODT clinical program also includes the ongoing Voyage and Panorama studies for GAD.

MDD is a prevalent mental health issue in the U.S., affecting over 21 million adults annually. It is a leading cause of disability worldwide and is associated with significant morbidity and mortality, as well as a substantial economic burden.

MindMed’s Chief Medical Officer, Daniel R. Karlin, M.D., M.A., expressed optimism about MM120 ODT’s therapeutic potential for the millions affected by MDD. The company aims to leverage the shared symptomatology between MDD and GAD to effectively match participants to the appropriate study.

Topline data from the double-blind period of the Emerge study is expected in the second half of 2026. The design and timing of a second MDD trial will depend on the progress of Emerge and further regulatory discussions.

The press release notes that the information is based on a press release statement and contains forward-looking statements regarding the anticipated outcomes and future plans for MM120 ODT.

In other recent news, MindMed reported a fourth-quarter 2024 earnings per share (EPS) of -0.41, missing analysts’ forecast of -0.31, and reported no revenue for the period. The company’s cash reserves increased significantly to $273.7 million by the end of 2024, up from $99.7 million in 2023, providing a financial buffer as they advance their Phase 3 clinical trials. H.C. Wainwright maintained its Buy rating for MindMed with a $55 price target, highlighting the upcoming Phase 3 clinical trial readouts as potential catalysts for the stock. The firm noted that MindMed’s program risk is mitigated by strong Phase 2b data and alignment with the FDA, which includes a Breakthrough Therapy Designation. Additionally, MindMed announced the appointment of Matt Wiley as Chief Commercial Officer, who will guide the commercial strategy for potential product launches, including the MM120 tablet for anxiety and depression disorders. Wiley’s appointment comes as MindMed prepares for key clinical readouts anticipated in 2026. These developments reflect the company’s strategic focus on advancing clinical trials and preparing for future commercialization efforts.

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