MindMed gets FDA breakthrough tag for LSD in anxiety

MindMed chief executive Robert Barrow

In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based candidate MM120 as a treatment for anxiety.

The development comes on the back of a proof-of-concept study involving patients with generalised anxiety disorder (GAD), reported in December, which showed that a single dose of MM120 achieved a significant and dose-dependent improvement in anxiety symptom scores over four weeks.

MindMed has provided an update to that study alongside news of the breakthrough designation, showing that the improvements on the Hamilton Anxiety Rating Scale (HAM-A) were sustained out to 12 weeks, fulfilling one of the secondary endpoints of the study.

At the new time point, MM120 was associated with a 65% clinical response rate, with 48% of patients considered to be in clinical remission.

The maximum observed effect with the drug is more than double the efficacy that would be expected with standard care for GAD, such as benzodiazepines and selective serotonin reuptake inhibitors (SSRIs), according to the company.

Shares in the company rose more than 50% following news of the breakthrough status, which recognises that a drug could offer a substantial improvement over available therapies and can speed up the review process.

Previous psychedelic medicines that have been given the designation include psilocybin for major depressive disorder (MDD) and treatment-resistant depression (TRD) and MDMA for post-traumatic stress disorder (PTSD).

“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety,” remarked David Feifel of the University of California, San Diego and Kadima Neuropsychiatry Institute, one of the investigators in the trial.

“That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” he added. “Those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials.”

MindMed has previously said it is hoping to have an end-of-phase 2 meeting with the FDA in the first half of 2024, with a view to starting phase 3 before the end of this year.

On a conference call, MindMed chief executive Robert Barrow said the data suggests that MM120 could answer a pressing need for new therapies for GAD, given that around half of the 13 million patients treated with currently available medicines in the US do not respond to initial therapy.

MM120’s profile could address serious limitations of current GAD drugs, including a slow onset of action, short-lived activity, and debilitating side effects, such as agitation, nausea and loss of appetite, dry mouth, insomnia, and sexual dysfunction.

“We are committed to bringing MM120 to people living with GAD and delivering on the potential of our pipeline to treat serious brain health disorders,” said Barrow.