Karlin on MindMed's Phase II Success and Psychedelic Therapy's Future

MindMed, a pharmaceutical company, recently announced that its therapy MM-120, which is based on LSD, has shown promising results in treating generalized anxiety disorder. In a Phase IIb clinical trial, the drug demonstrated a significant reduction in anxiety levels on the Hamilton scale when compared to a placebo after a four-week treatment period. The findings have bolstered the field of psychedelic treatments, following the submission of a New Drug Application to the FDA by MAPS Public Benefit Corporation for an MDMA-assisted therapy for post-traumatic stress disorder in December.

In an interview with BioSpace, MindMed's Chief Medical Officer, Dan Karlin, highlighted the impressive response rate of 78% observed in the Phase II results. He emphasized the drug's effectiveness without the need for traditional psychedelic therapy components, such as preparation or integration sessions, which sets MindMed apart in the industry. The study's design integrity was also reinforced by a robust placebo response.

Looking ahead, MindMed plans to delve into the data to identify predictors of response and response domains. The company intends to engage with the FDA to discuss the study and its plans for Phase III, which is expected to commence in the first half of 2024. Despite LSD's current Schedule I status and associated legal challenges, MindMed has shown adeptness in managing the operational complexities, including secure storage and licensing requirements. The company anticipates that as the drug progresses towards FDA approval, a rescheduling process will be initiated, similar to what has occurred with other drugs like MDMA and psilocybin.

Karlin also shared that MindMed has had positive interactions with regulators, who have released guidance on developing psychedelics. The FDA appears to view these treatments as potentially beneficial if proven effective and is taking a proactive approach to their regulation. MindMed is eager to continue collaborating with the FDA to ensure alignment and understanding in study design and data interpretation.

Reflecting on MindMed's position in the broader psychedelic treatment landscape, Karlin expressed hope for the entire field, given the significant unmet needs in psychiatry. He stated that MindMed would be supportive of other companies developing treatments for those lacking adequate options, as it aligns with the overarching goal of reducing human suffering.