At that time, the research marked the first time LSD had been studied in a medicinal setting in more than 40 years. GAD is an anxiety disorder characterized by excessive and persistent worrying about daily issues. The condition affects about 6.8 million U.S. adults, about 3.1% of the population, each year. Women are nearly twice as likely as men to be diagnosed with an anxiety disorder in their lifetime, according to data from the Anxiety Disorders Association of America. In addition to frequent worrying, the symptoms of GAD include restlessness, fatigue, trouble concentrating, irritability, increased muscle tension, and trouble sleeping.

  “Generalized anxiety disorder is a common condition associated with significant impairment that adversely affects millions of people and there remains a serious unmet need for this patient population,” said MindMed chief medical officer Daniel Karlin, M.D. “The pharmaceutical industry has largely ignored GAD over recent decades as it has proved extremely difficult to target. Few new treatment options have shown robust activity in GAD since the last new drug approval in 2004, making the strong, rapid, and durable clinical activity of a single dose of MM-120 observed in the trial particularly notable.

” To conduct the Phase 2b clinical trial, researchers recruited 198 participants with a primary psychiatric diagnosis of generalized anxiety disorder (GAD). The study participants were enrolled in the trial from 20 sites across the country. Participants were randomized to receive a single administration of MM-120 at a dose of 25, 50, 100 or 200 micrograms or a placebo. The single dose was administered in a monitored clinical setting with no additional therapeutic intervention. The primary objective of the study was to determine the dose-response relationship of the four different doses of MM-120 compared to placebo as measured by the change in the Hamilton Anxiety Rating Scale (HAM-A), a diagnostic tool used to measure the severity of anxiety symptoms.

The study met its primary endpoint, demonstrating a statistically significant dose-dependent improvement in HAM-A scores after four weeks. The clinical activity was observed to be rapid and durable beginning on the second day of treatment and continuing through the fourth week of the study with no loss of activity observed on either the HAM-A or the Clinical Global Impressions-Severity (CGI-S), another psychiatric diagnostic tool used by researchers. On average, participants receiving higher doses of the drug experienced a 2-unit improvement in the CGI-S score after four weeks, with statistically significant improvements observed as early as one day after treatment and continuing at all evaluated time points through the fourth week.

   MM-120 was generally observed to be well tolerated, with mostly transient mild-to-moderate adverse events that appear consistent with the pharmacodynamic effects of the drug. MindMed’s MM-120 is a form of LSD that has been slightly altered to reduce the intensity and duration of the psychedelic effects of the drug. The company plans to continue research to investigate the potential of the drug to treat GAD, with other studies planned to study MM-120’s effect on patients with attention-deficit/hyperactivity disorder (ADHD).

“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,” Robert Barrow, chief executive officer and director of MindMed, said in a recent statement from the company. “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.

”  “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,” he added. Read less