Guest Column | March 13, 2024

Supplying Complex, Controversial, And Intercontinental Clinical Trials

A conversation with Amy Reichelt, Ph.D., chief innovation officer, PurMinds NeuroPharma

Australian departure board-GettyImages-157336349

Most nations still view psilocybin the same way the U.S. Drug Enforcement Agency does — as a compound with no accepted therapeutic benefit and a high potential for abuse.

That complicates things when you’re a small psychedelics company looking to start a Phase 2A clinical trial for patients with Parkinson’s disease who have major depressive symptoms.

PurMinds NeuroPharma, a psychedelic startup in Ontario with a botanical form of psilocybin extracted from mushrooms, is gearing up to begin testing efficacy for its PUR101 candidate in about 40 patients with early-stage Parkinson’s. For a class of drug that has slowly been gaining social acceptance, including in Canada, running a trial domestically might seem like the obvious choice.

Instead, PurMinds is engaging with CROs in Australia and planning to ship doses to the opposite side of the globe. Aside from the sheer challenge of setting up such a trial — they need to establish safety and pharmacokinetics/pharmacodynamics for a drug that may be subject to dose-to-dose variations — threading the logistical needle presents notable challenges.

We asked PurMinds Chief Innovation Officer Amy Reichelt, Ph.D., about the path ahead. We started with why they picked Australia and what considerations they’re making when planning to move botanically-derived medicine across continents. Reichelt spent part of her career working on clinical trials in Australia, and she knows the landscape. Likewise, PurMinds’ supply strategy illustrates how the right financial incentives, a receptive audience, and the right professional connections can outweigh the most daunting logistical hurdles.

Her answers have been edited for clarity and length.

What about Australia makes it an attractive country to develop clinical programs for psychedelics or any other type of drug?

Reichelt: There are two major aspects to running clinical trials in Australia. First, it’s the truncated IND-enabling package requirements. For instance, with a new chemical entity, a new molecule for therapeutic use, you don’t have to have the full IND-enabling package in place.

We just need to do preclinical studies to show safety and also to draw upon literature to show the safety of using psilocybin in humans. There is that leeway, which allows us to run the IND-enabling studies in accordance with the FDA‘s requirements at the same time as running the clinical trial.

It’s favorable to be able to show some human data to the FDA because you can say, “Look, It’s safe and tolerable.”

As well, we have the tax incentive. Small startups and small to medium enterprises like PurMinds can form an entity in Australia, and then they will benefit from the Australian R&D tax incentives, which equate to 43.5% (in refundable tax offsets).

That’s not a small amount of money. That makes it very encouraging to be able to conduct clinical trials in an efficient and cost-effective way.

Australia’s population also seems very open to psychedelics. Particularly, there was the rescheduling of psilocybin and MDMA that took place in July last year. There is that acceptance around psychedelics, particularly psilocybin, as being something therapeutically important.  

What does it take to get highly controlled and delicate drug product from one country to another?

Reichelt: There’s a lot of paperwork and bureaucracy involved. You must have both an export license and the receiving party must have that import license. Luckily, the CROs that we’re talking to have previously run trials with psilocybin, so it makes it much more straightforward when you work with somebody who has already done this.

It has to be legally shipped with the right courier under the right conditions, which is important. As part of the drug development process, we have to develop the excipients and show stabilization, and then the drug has to be sent to a location with the correct storage conditions for it.

It’s got to be in a locked safe. It’s got to be in a pharmacy. But there’s also the temperature aspect of it.

When we ship something that’s temperature stable and packed appropriately to undergo a long journey on a plane from Canada to Australia, we don’t want it to sit on a runway or in storage on a 45-degree Celsius day and then have our product ruined.

It’s picking the right courier service to avoid that.

Then there would be no need to do any cultivation or production in Australia? All that can stay in North America?

Reichelt: Our plan is to maintain the focus on cultivation within our facility in Canada at the moment rather than going out to Australia.

I think Canada has had the upper hand when it came to the licenses for growing these psychedelic mushrooms through the country’s more mature regulatory frameworks. Because of that, it enabled Health Canada to issue the right licenses. There’s only a handful of companies that actually have these licenses in Canada currently as the license represents a high barrier to entry – taking two to five years to acquire and significant upfront capital expenditure.

Is there any concern that you won’t be able to produce enough medicine to satisfy the needs of the trials?

Reichelt: At the moment, we’re in the process of expanding our facility and establishing everything up to GMP certification levels. So, the average psilocybin-containing mushroom is only between 1% and 1.4% psilocybin, so we need an awful lot of mushrooms, and there’s a whole lot of biomatter associated with that.

But again, it’s getting the facility up to speed, making sure everything is done in the appropriate conditions so there’s no loss of crops and no contamination. Everything has to be third-party verified in terms of the constituents. It’s also quite fortunate that mushrooms grow quite quickly. They get to the cultivation stage in about a month. So, you can have quite a fast turnaround.

What advice would you have for other companies that are trying to deliver a complicated drug to trial patients receiving care on other continents?

Reichelt: The best thing to do is work with a CRO that is on the ground in the country you’re going to be running your clinical trial in. Try to find the experts who have experience in this space.

The experience that comes with running a clinical trial with psychedelics, it’s much different than running a clinical trial that doesn’t have consciousness-altering properties as being one of its major therapeutic mechanisms of action, potentially.

Following in the footsteps of other giants is the most important thing for, particularly, small companies.

About The Expert:

Amy Reichelt, Ph.D., is an expert in neuroscience and neuropharmacology, specializing in psychedelic clinical development. She earned her Ph.D. at Cardiff University and has worked in academic settings on three continents. She has authored more than 60 articles in scientific journals, spoken on international stages including Microdose Wonderland and TEDxSydney, and appeared as a scientific expert in TV productions including ABC’s The Science of Drugs.