Anxiety treated with single dose of psychedelic drug in phase 2b trial

Four weeks after receiving a 100 µg dose of the drug candidate, patients saw a significant reduction in anxiety symptoms compared to a placebo, shown by a 7.6 point drop in the Hamilton Anxiety rating scale (HAM-A). According to the scale, a score lower than 17 signals mild anxiety and 25-30 indicates moderate to severe anxiety.

GAD is a common condition​ that causes feelings of persistent anxiety, fear and excessive worry, and can negatively impact daily life.

“The pharmaceutical industry has largely ignored GAD over recent decades as it has proved extremely difficult to target,” said Daniel Karlin, Chief Medical Officer of MindMed in a public statement. “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.”

MindMed’s trial enrolled 198 participants who received either MM-120 at 25, 50, 100 or 200 µg or a placebo. The participants had severe GAD at baseline, with an average HAM-A score of approximately 30.

A total of 78% of patients receiving either 100 µg or 200 µg of the drug candidate saw a clinical response, a drop of 50% or more in their HAM-A score, compared to 31% in the placebo group. Meanwhile, half of the patients given 100 µg of MM-120 saw a clinical remission, represented by a HAM-A score of less than 7.

The company saw the drug was overall well-tolerated and that the mostly mild-to-moderate adverse events, such as illusion, hallucinations, euphoric mood, happened on the day of dosing.