MindMed’s stock price jumped over 50% Thursday as its LSD-based candidate for generalized anxiety disorder got a breakthrough therapy designation from the FDA.
Pictured: FDA sign at agency’s headquarters/iStock, JHVEPhoto
Psychedelic biotech MindMed has hit another milestone with its LSD treatment MM120 (lysergide d-tartrate), as the FDA granted it a breakthrough designation Thursday after reporting positive Phase IIb results.
The news of the FDA designation sent MindMed’s stock up over 50% when the closing bell rang Thursday. MindMed’s stock price gained another 4% pre-market.
The MM120 candidate, a treatment for patients with generalized anxiety disorder (GAD), also reached an endpoint in a Phase IIb study of the drug while showing clinical and statistically significant durability of activity being observed through week 12.
“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase IIb study provides further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” MindMed CEO Robert Barrow said in a statement. “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.”
In December 2023, the biotech announced that the drug had shown significant and clinically meaningful improvements on the Hamilton Anxiety rating scale against a placebo, which was the primary endpoint. A dose of MM120 at 100µg showed a 7.7-point improvement over a placebo, netting a p-value of <0.0003 with a 65% clinical response rate and a 48% clinical remission rate sustained at week 12.
The clinical global impressions severity scores also improved from 4.8 to 2.2 on average, marking a two-category shift from markedly ill to borderline ill, according to MindMed. This earned a p-value of <0.004.
In January 2024, MindMed’s CMO Dan Karlin discussed the Phase II win in more detail and discussed the company’s future in psychedelic treatment.
MindMed said that based on the unmet medical need for the treatment of generalized anxiety disorder, the Phase IIb data and other research, the FDA decided to grant the designation to the biotech. MindMed will hold an end-of-Phase II meeting with the regulator sometime in the first half of 2024 and will start Phase III in the latter half of the year.
“As a clinician and clinical researcher, I applaud the way this study was designed by MindMed to isolate the effect of MM120 by removing confounding variables like additional medications and psychotherapy,” Reid Robison, a psychiatrist, chief clinical officer at Numinus and investigator in the MM120 study, said in a statement. “It gives me confidence in the data, and the positive results give me hope that this may translate into meaningful benefits for my patients.”
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
