MindMed Begins First-Ever Clinical Trial On MDMA, LSD Combinations

Mind Medicine (MindMed) Inc MMEDF, a medicine biotech company in psychedelics, on Wednesday announced its start of the first-ever clinical trial measuring and evaluating 3,4-methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) combinations in the human body, at the University Hospital Basel Liechti Lab, in Basel, Switzerland.

What Happened: On the heels of raising nearly $184 million in financing, as well as successful patent filings and completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration, MindMed is evaluating whether MDMA, when balanced and used in combination with LSD, can offset the unpleasant effects of LSD in therapy or clinical settings.

“There’s a deep history of using MDMA, combined with LSD, in the recreational space -- it’s called Candy Flipping,” MindMed co-founder and co-CEO J.R. Rahn told Benzinga. “We’re really focused on it for therapeutic purposes.”

Alone, MDMA opens and relaxes patients, while LSD addresses anxiety. Over approximately one year, the double-blind, placebo-controlled, 4-period crossover design study will help MindMed determine whether the drugs can be combined in the human body, and in what dose.

“Once we have that data, we want to apply this to all of our potential indications and programs,” Rahn said in a statement on MindMed’s close work with the FDA. “Once we get a good readout on the safety profile of MDMA and LSD, we will then want to … create a Phase 2 clinical program.”

Why It Matters: In deploying alternative solutions for mental illnesses -- those without acute adverse effects such as abuse and dependence -- in collaboration with the world’s leading psychedelics, pharmacology and clinical research groups, MindMed is destigmatizing psychedelics on the premise they can be therapeutic.

This comes as more than half of all U.S. counties don’t have a psychiatrist, while medicines remain unaltered for nearly 40 years.

“We didn’t just start a new company with MindMed. We founded a new asset class and industry,” Rahn said on creating scalable, next generation commercial medicines for mental health.

“2020 was about founding the asset class, and getting institutional investors to understand what we’re doing. I think 2021, and beyond, is really about how we build this industry and new paradigm -- an asset class to sustain itself -- to heal people over the long term.”