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CEO George Goldsmith says the key is using the hallucinogenic as part of a broader therapy.
● Goldsmith and his physician wife were drawn to research on hallucinogenic mushrooms while seeking a treatment for their son’s mental health issues.● The Food and Drug Administration designated their work a “breakthrough therapy” in 2018 ● It’s now in Phase II trials
There’s a tremendous amount of suffering.
And I think we’ve been pretty good at developing tools to ameliorate 70% of that.
But [helping] the other 30% is quite difficult.So we have the opportunity to do something unique here.
Well, I think it has the potential to be a therapy.It’s really important that it’s not just a drug.It’s a drug that’s given in combination with psychological support, and that’s the critical bit.
We provide a very high dose of psilocybin in a carefully controlled setting under supervision by specially trained therapists—so this isn’t anything to do at home.
Patients listen to a special soundtrack, and they’re really supported through this process.Afterwards, many patients experience an immediate reduction in depression that actually lasts for quite a while.
We’re operating now in 10 countries doing clinical research in 21 research sites.We’re looking at how do we do the real, deep research to generate the information and insight we need to go to Phase III trials.
Absolutely, because obviously there’s a history here.
So the first port of call for us was to speak with regulators and payers, and they saw this is promising.There’s almost a third of [depression] patients who aren’t helped by [conventional] medicines.I think there’s a huge opportunity to develop a new model of care for them.
The third of patients that aren’t helped actually are about two to four times more expensive than patients who are helped by these medicines.And so we not only have a very large group of patients who aren’t helped, but also those are the most expensive patients.
No.We’re really thinking about the huge unmet need for patients.
And what we’re really focused on is access.And that means approval by Medicaid, by insurers.So from Day 1 we’ve been really focusing on making sure that if this is successful in trials, people have access to it.That means working with insurers even in the design of clinical trials to make sure they have the evidence.Because this is for this patient population.
That’s super-important to us.It’s a different model than a recreational model.
Bloomberg Businessweek With Carol Massar
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