Psychedelic medicine CEO eyes chances under MAHA
As CEO of the psychedelic medicine company Compass Pathways, Kabir Nath has had a front-row seat to a dramatic year in the field of psychedelics.
Once an industry darling, Compass' competitor Lykos Therapeutics was brought to its knees last summer when the Food and Drug Administration turned down the drugmaker's application for the psychedelic drug MDMA combined with talk therapy as a treatment for post-traumatic stress disorder.
Lykos quickly shed staff and top leadership following the decision, including board member Rick Doblin, who spent decades campaigning for FDA approval of the drug.
The rejection also had a chilling effect on the industry at large. Compass delayed results from its late-stage psychedelics trials and laid off 30 percent of its staff.
But the environment has started to thaw in recent months. President Donald Trump's appointees, including HHS Secretary Robert F. Kennedy Jr. and VA Secretary Doug Collins, have sparked excitement among psychedelics proponents by touting psychedelic therapy's promise as a treatment for veterans with mental illness.
In June, Kennedy offered a progress update on psychedelic therapies. 'We are working very hard to make sure that that happens within 12 months,' he told members of Congress.
In late June, Compass released topline results from its Phase III trial of a synthetic form of psilocybin, which is derived from psychedelic mushrooms, as a therapy for treatment-resistant depression.
While full findings won't be released until later this year, preliminary results found that after six weeks, a single dose of synthetic psilocybin reduced participants' depression scores by 3.6 points compared with a placebo group in a randomized trial of 258 people.
Erin caught up with Nath to learn more about what's next for Compass and how the company is positioning itself under the new administration.
This conversation has been edited for length and clarity.
How are you feeling about your chances of FDA approval since Trump took office?
We plan to meet with the FDA to discuss that and to talk about any potential for accelerating the filing.
Right now, our base case continues to be that we will need both of the Phase III studies. The second one reads out at the second half in 2026, so that continues to be our base case, because that's the existing alignment we have with the agency.
We're encouraged by the fact that there are voices in the administration at different levels who seem to share our view of the potential for psychedelics and share an interest in trying to get them accelerated, subject to doing the right rigorous studies and getting the science right.
Which voices in the administration are you thinking of?
What's in the public domain is that both RFK Jr. and Secretary Collins have talked about trying to find a way to make psychedelics available within 12 months.
That has to be defined. Does that mean a full approval? Does that mean some sort of framework of early access?
What we're excited to do is to find opportunities to partner if we can, so that whether it's earlier access, or whether it's some sort of pilot program, we could participate in that.
But crucially, we want to respect the integrity of the FDA approval process. That's fundamental to us, because that is the gold standard for assuring safety and effectiveness.
FDA Commissioner Marty Makary has also spoken publicly about psychedelics.
There are a number of people who are on record saying they see the potential. But to be clear, we're not asking for psychedelic exceptionalism. We're not asking for a different standard.
We've done two very large studies in patients with treatment-resistant depression, and we are two for two in showing highly statistically significant positive results after a single dose.
In this population of really hard-to-treat depression, we think that is probably a unique achievement, but we'll call it remarkable.
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TECH MAZE
Bruce Siegel, the outgoing president and CEO of America's Essential Hospitals, which represents hospitals that serve low-income patients, is retiring at the end of the year — after leading the group for 15 years and spending a nearly four-decade career in health policy and hospital administration.
In an extended conversation with POLITICO's Kelly Hooper, he spoke about the impact of the tax legislation recently signed into law — containing more than $1 trillion in health care cuts — including new limits on provider taxes, work requirements and provisions that target Medicaid-directed payments and a $50 billion rural hospital fund Republicans included in the law to mitigate the impact on safety-net hospitals.
Siegel also addressed the impact of technology on the health care sector.
What might the future look like as new technology is increasingly integrated into care?
I don't know how [artificial intelligence] plays out going forward. There's huge opportunities with AI to improve care, to predict what will happen to patients, to better communicate with patients. That's great. I also think that there's dangers in AI. Will AI increase disparities for some populations? It could. Could AI be used to redline communities or redline groups of patients? 'Hey, they're too risky.' Yeah, it could. There could be negative uses, and we're going to have to have some guardrails and a serious conversation about that.
I was asked recently at a conference how I felt about the use of large data systems and AI to understand and inform how we treat the individual patient based on their genetics. And my response to that was that it could be very exciting, that level of personalized care, but would it also mean that my health data is now being bought and sold out there? And that's really valuable data. It's incredibly valuable data for underwriters, insurers, developers, all kinds of people. So we need to have some pretty firm understanding and some pretty firm guardrails around whose data is this and how it gets used.
Read Siegel's full interview with Kelly on POLITICO Pro.
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