MindMed readying Phase III trials for LSD therapy to treat anxiety

By Steve Gelsi

MindMed Inc. said Tuesday it's on track to launch Phase 3 clinical trials with up to 440 people starting later this year for its treatment of generalized anxiety disorder (GAD) through use of lysergide D-tartrate (LSD) in a clinical setting.

MindMed is working on winning approval from the U.S. Food and Drug Administration for an anxiety therapy using LSD.

The company is using synthetic ergotamine, which is part of the group of psychedelic drugs.

"We are well-positioned to rapidly advance our research and development pipeline," the company said.

MindMed's (MNMD) stock was up 2.5% in premarket trading on Tuesday.

MindMed plans to launch its first Phase 3 study later this year with 200 people and a second study with up to 240 people in the first half of 2025.

Both studies will generate Part A results by the end of 2026.

MindMed said its second-quarter loss narrowed to $5.86 million, or 26 cents a share, from $29.41 million, or 76 cents a share, in the year-ago quarter.

The New York-based company disclosed $243.1 million in cash as of June 30, and it also closed a $75 million stock offering in recent days.

Prior to Tuesday's moves, MindMed's stock was up 87.2% so far in 2024, ahead of the 11.8% rise by the Nasdaq COMP.

The upcoming Phase 3 trials for MindMed came after the FDA asked for an additional Phase 3 study from applicant Lykos Therapeutics on a PTSD therapy treatment using MDMA, also known as the club drug Molly.

Also read: Psychedelic-drug contenders suffer stock-market drops after FDA rejects MDMA treatment

-Steve Gelsi

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08-13-24 0900ET

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