In this Issue

• In this Issue
• Psychedelic CEOs’ FDA Wish-List
• APA Division 56 President Jessica Punzo on Psychologists and Psychedelics
• Compass’ Phase 2 PTSD Study Published
• Cybin Ousts CEO Doug Drysdale
• DoD to Test Military for Psilocybin
• MindMed’s Phase 2b LSD for GAD Study Publishes
• and more…

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Psychedelic Science in Denver feels like many moons ago. Indeed, it’s been a blur since: right after the conference wrapped, Compass Pathways shared a topline readout from its first Phase 3 program, then Beckley Psytech shared results from its Phase 2b study, then Germany established the EU’s first psilocybin compassionate use program, then the AbbVie-Gilgamesh rumour mill fired up again, and so on and so on. (And, yesterday’s surprise release of the Complete Response Letter that FDA sent Lykos Therapeutics last year!)

Now that the dust has settled for a moment, we revisited our notes from the gathering and pulled out two conversations to feature in this Issue.

The first was a discussion between Compass CEO Kabir Nath, and former (more on that below) Cybin CEO Doug Drysdale, moderated by former Lykos Therapeutics CEO Amy Emerson.

The second discussion saw our Editor, Josh Hardman, sit down with Jessica Punzo, President of the American Psychological Association’s Trauma Psychology Division.

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Psychedelic CEOs’ FDA Wish-List

Two Brits (“Just so you know, you do not have to be British to run a psychedelics company!”, Nath joked), each a CEO—at the time of speaking—of a publicly-traded psychedelics company with Phase 3 studies underway, Nath and Drysdale were interviewed on-stage by Emerson in a session titled: The Home Stretch: Pivotal Trials and Preparing for Launch

The trio discussed issues related to infrastructure for psychedelic therapies, the regulatory climate in the U.S., and commercialisation.

When asked about his views on the current regulatory climate in the states, Drysdale said that there is “nothing to be unhappy about”. ‘They’re learning, as we are’, the Cybin CEO added, noting that FDA ‘is asking for a lot, but important questions.’

Nath said that the agency has been ‘broadly supportive’, though he did have a wish-list of sorts, or ideas of where the agency could better support drug developers in the field.

Conventional oral medicines in psychiatry are used off-label from day 1, Nath told the audience, with up to 75% of prescriptions being for off-label use, in some cases.

But the Risk Evaluation and Mitigation Strategy (REMS) that will be a condition of the approval of a psychedelic could make such off-label use tricky. Psychedelic REMS will be ‘somewhat restrictive’, in Nath’s words.

While manufacturers must be careful not to encourage off-label use, it can provide an excellent source of real-world evidence that a company might use as a signal to inform label expansion efforts.

But label expansion, as conventionally imagined, is expensive, and generally requires a return to Phase 3 programs. ‘If for each indication we have to do two well-controlled phase 3 studies,’ Nath said, ‘it’s going to be decades’. ‘Patients won’t wait, psychiatrists won’t wait’, he added.

Might developers, like Compass, be able to supplement data from randomised controlled trials with real-world evidence, he wondered out loud.

That could substantially reduce the barrier to expanding the label, which is especially relevant to psychedelic drug developers who are almost all pre-revenue and would be launching with a single asset. It’s also a very expensive drug development niche, with complex protocols, scarce clinical trial availability, and so on.

While permitting label expansion without a conventional two-trial phase 3 program might appear a little dicey if it were a migraine drug being trialled for gout, it might make much more sense in the realm of mental health, where the boundaries between diseases are often fuzzy and co-morbidities are common. (TRD, for example, is not even defined in the Diagnostic and Statistical Manual of Mental Disorders—which is deemed to be the classification of mental health conditions.)

Of course, it’s in the interest of execs like Nath to encourage FDA to streamline indication expansion: it would make it much cheaper and quicker for manufacturers to reach additional markets.

But, it does also sound like one of the more common-sense suggestions that has been thrown around in the realm of healthcare. Remember, ‘new markets’ = new patient populations who might benefit from the treatment, and getting them on-label is a win for accessibility, as it should encourage reimbursement.

Nath said that the prospect requires ‘dialogue’ and ‘navigation’ to try and work out a solution with the agency. He also said that he was ‘excited to see whether, with these new voices and ideas within the administration, we can bring this forward.’

(At another talk on the Business track, former FDA reviewer and current Lykos CMO Javier Muniz said that drug developers shouldn’t necessarily view their interactions with the agency as a one-way street. Instead, they should be prepared to push back, where they are within reason.)

Another area that could streamline the roll-out of psychedelic therapies is harmonising training programs, the Compass exec added later.

‘Currently, training is for one molecule for one indication’, Nath explained, saying that the situation is not sustainable. There is a common interest among drug developers, he argued, to work on this.

“It’s far too early to be worrying about competitors”, he laughed, “If Doug and I ever reach that point, we will have won!”

“Just to say, I’m already trying to win… we’re already competing, you just don’t know it yet!”, Drysdale, the outgoing Cybin CEO, laughed.

But he agreed with Nath’s point…

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