“This is the first study to assess the standalone drug effects of MM-120 in the absence of any psychotherapeutic intervention.”
The topline results from a phase 2b clinical trial of lysergide d-tartrate (MM-120) for generalized anxiety disorder (GAD) announced today demonstrated that the trial met its primary endpoint.
MindMed, the developer of MM-120, announced that the trial—Study MMED008—successfully met its primary endpoint by demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety Rating Scale (HAM-A) compared when placebo at week 4. Administered as a single dose in a monitored clinical setting with no additional therapeutic intervention, MM-120 exhibited promising outcomes.1
The 100 µg dose of MM-120, associated with the highest clinical activity, showed a 7.6-point reduction compared with placebo at week 4 (-21.3 MM-120 vs -13.7 placebo; p<0.0004; Cohen’s d=0.88). Clinical Global Impressions—Severity (CGI-S) scores improved significantly in the 100 µg dose group, shifting from “markedly ill” to “borderline ill” at week 4 (p<0.001). The investigators noted that this clinical activity was both rapid and durable, commencing on day 2 and persisting through week 4 with no loss of efficacy observed.1
Secondary and exploratory endpoints, including HAM-A response and remission rates and CGI-S scores, were also positive. Clinical response at week 4 was achieved in 78% of participants treated with MM-120 compared with 31% of those treated with placebo. Clinical remission at week 4 was achieved in 50% of participants treated with MM-120 100 µg. CGI-S scores demonstrated statistically significant improvements in the 100 µg and 200 µg dose groups.1
MM-120 was generally well-tolerated throughout the trial, with transient mild to moderate adverse events consistent with the pharmacodynamic effects of the drug. The completion rate for the trial was approximately 90%, reaching 97.5% in the high-dose groups, with no participants discontinuing due to adverse events.1
“We are excited by the strong positive results for MM-120 in GAD, particularly given that this is the first study to assess the standalone drug effects of MM-120 in the absence of any psychotherapeutic intervention,” said Robert Barrow, chief executive officer and director of MindMed, in a press release. “These promising findings represent a major step forward in our goal to bring a paradigm-shifting treatment to the millions of patients who are profoundly impacted by GAD.”
MindMed expects these positive results to support the progression of MM-120 into phase 3 clinical development for GAD. An end-of-phase 2 meeting with the US Food & Drug Administration (FDA) is planned for the first half of 2024, with phase 3 clinical trials anticipated to commence in the second half of 2024. Additional topline 12-week data from MMED008 is expected to be presented in the first quarter of 2024, with full results slated for presentation in 2024.1
“We look forward to sharing additional study results in the coming months—including topline 12-week results in the first quarter of 2024—and working closely with FDA as we finalize the phase 3 development program for MM-120 in GAD,” Barrow said in a press release. “I would like to thank all of the participants in the study, as well as the study investigators and our clinical development team, whose dedication made this important milestone possible.”
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Note: This article was prepared with the assistance of ChatGPT.
1. MindMed announces positive topline results from phase 2b trial of MM-120 in generalized anxiety disorder. BusinessWire. News release. December 14, 2023. Accessed December 14, 2023. https://www.businesswire.com/news/home/20231214537387/en/MindMed-Announces-Positive-Topline-Results-from-Phase-2b-Trial-of-MM-120-in-Generalized-Anxiety-Disorder