Mind Medicine (MindMed) (NASDAQ:MNMD) announced that the FDA has granted the "breakthrough therapy" designation to its MM120 (lysergide d-tartrate) program for the treatment of Generalized Anxiety Disorder (GAD).
The clinical-stage psychedelics biotech firm will now join industry counterparts Lykos Therapeutics (formerly MAPS PBC) and Compass Pathways (NASDAQ:CMPS), who also obtained the FDA’s for MDMA-assisted therapy to treat PTSD and psilocybin-assisted therapy for treatment-resistant depression (TRD).
The company announced that, based on the significant unmet medical need in the treatment of GAD, especially in patients who do not respond to or tolerate currently available medications, this news as well as initial clinical data from other research, the FDA has designated MM120 for GAD as a breakthrough therapy.
"The FDA's decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provides further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD," said MindMed CEO and director Robert Barrow. "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."
The Company plans to hold an end-of-Phase 2 meeting with the FDA in the first half of 2024, and initiate a Phase 3 clinical program in the second half of 2024.
Positive 12-Week Treatment Sustainability Data
MindMed also announced that its Phase 2b study of MM120 in GAD met its key secondary endpoint: 12-week topline data demonstrated the compound's effects to be "clinically and statistically significant" through Week 12.
Lysergide is a synthetic substance belonging to the group of classic or serotonergic psychedelics. It acts as a partial agonist of the human brain's 5-HT2A receptors. The company is developing MM120, the tartrate salt form of lysergide, for GAD and is reportedly exploring its potential applications in other mental health disorders.
MindMed previously announced rapid, clinically meaningful and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4, (the trial's primary endpoint.)
In the completed Phase 2b clinical trial, MM120 was administered as a single dose in a monitored clinical setting, with no additional therapeutic intervention. Prior to treatment, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.
The multi-center study (MMED008) enrolled 198 participants with severe GAD symptoms, who were randomized to receive a single administration of MM120 at a dose of 25, 50, 100 or 200 micrograms (µg) or placebo. The full analysis set for the trial included 194 subjects who had at least one valid post-baseline Hamilton Anxiety rating scale (HAM-A) score.
The compound was generally well-tolerated, with most adverse events rated as mild-to-moderate, transient and occurring on dosing day, and "being consistent with expected acute effects of the study drug."
The most common adverse events (at least 10% incidence in the high dose groups) on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis.
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