After reporting positive mid-stage results for its LSD-based therapy for generalized anxiety disorder, MindMed’s chief medical officer sat down with BioSpace to discuss the path forward.
Pictured: A psychedelic collage/Nicole Bean for BioSpace
Last month, MindMed reported that its LSD-based therapy for generalized anxiety disorder, MM-120, met the primary endpoint in a Phase IIb study. Topline results showed that a 100 µg dose of the drug elicited a 7.6-point reduction on the Hamilton scale compared to the placebo after four weeks of treatment.
This result added to building momentum in the psychedelics treatment space after MAPS Public Benefit Corporation submitted a New Drug Application to the FDA for an MDMA-assisted therapy intended to treat post-traumatic stress disorder earlier in December.
BioSpace sat down with MindMed Chief Medical Officer Dan Karlin to discuss MM-120, what the latest data means for the company’s future and where it currently sits with regulators.
Editor’s Note: This interview has been lightly edited for brevity.
BSp: What were some surprising things you saw in the Phase II results for MM-120?
DK: The fact that we saw a 78% response rate. . . . This level of performance against placebo, while what we hoped for, performed as well as we possibly could have expected. We saw a nice, dose-dependent effect on anxiety out to four weeks, and we still have 12-week data that we’ll need to read out in Q1. But the performance to four weeks is extremely promising for this to be successful moving forward. We also saw a robust placebo response . . . [which] reassures us of the integrity of the study design.
The other thing that I think is worth noting is that we did this study in a delivery paradigm that didn’t include a lot of the things that other people in the field think are necessary for drug effects [with psychedelics]. So, we didn’t do preparation or integration sessions. We didn’t do psychedelic-assisted psychotherapy. This was just a drug effect, and the fact that we saw a drug effect independent of a psychotherapeutic add-on component is extremely promising; it’s something that we put a bet on, right? This is . . . one of a few ways that we differentiate ourselves from others in the field.
BSp: What are the next steps for the drug?
DK: We are deeply interested in analyzing the data to a highly granular level to understand things like predictors of response and domains of response. . . . We will meet with the FDA to discuss this study and our plans for Phase III, which should happen in the first half of next year [2024]. . . . Then, we will start a Phase III development program in the second half of next year.
BSp: With LSD still being a Schedule I drug and highly illegal, how does MindMed plan to work around this barrier?
DK: We’ve demonstrated through this Phase II study that we’re very capable of dealing with some of the operational overhead that the current Schedule I status brings. So, all of our sites need to have plan one licenses, they need to have secure storage conditions and they need to meet the requirements to have that kind of license. The manufacturing facilities and import/export all have strict controls around it, but that’s administrative overhead. It’s not a blocker; it may sometimes make things more work-intensive or introduce delays. The efficiency with which we prosecuted the Phase II study tells you quite a bit about how we can deal with those administrative hurdles.
In general, and we’ve seen this with plenty of other drugs when a drug is adjudicated by the FDA to have a medical use, a rescheduling process occurs. So, there will be a scheduled recommendation from the FDA to the DEA [Drug Enforcement Administration]. We expect that, as with MDMA and psilocybin that may have applications . . . this process of rescheduling will happen on both the federal and state level where some states track with the national automatically [and] other states will have to do manual rescheduling as a state-based action. Still, we expect that as we finish up our Phase III and submit an NDA to the FDA and move toward approval, that rescheduling will be something that happens.
BSp: What has the conversation with regulators been surrounding MM-120?
DK: We’ve had positive interactions with the regulators. . . . Especially based on the fact that they’ve now released guidance on developing psychedelics, we think that the FDA sees this as something good for the world if they can be shown to be effective and that the FDA is taking a proactive approach to regulating them. So we’re looking forward to future interactions with the FDA. Especially when you’re doing something unusual, you try to take advantage of every opportunity to interact with the regulator and ensure that you’re staying aligned, understand each other’s concerns and interests and are aligned on study design and data.
BSp: How do you see MindMed in the wider psychedelic treatment space?
DK: Given the amount of unmet need in psychiatry in general . . . we’re hopeful for everybody. We would love to see other companies who are developing drugs to try to help people who don’t currently have adequate treatment options succeed because that ultimately alleviates suffering, and that’s our goal.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
Editor’s note: This story was first published on January 8.
