🫠 Psychonaut POV

Welcome to Tricycle Day. We’ve got the whooole mushroom in our hands. We’ve got the whole magic mushroom in our hands. 🎶

Ben Lightburn isn’t your typical pharma CEO. Unlike most psychedelic biotechs, his company Filament Health doesn’t isolate molecules or synthesize patentable analogs. He believes in using the whole plant—or fungus, as the case may be—just as nature intended.

We spoke to Ben about the advantages of botanical medicine, building a psychedelic pharma company without drug patents, and how Filament is making psilocybin accessible today.

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How did you first develop an interest in plant medicine, and how did that interest lead to the founding of Filament?

I've been working with natural substances for my whole career. Plant compounds are used across all kinds of industries—not just pharmaceuticals and nutraceuticals, of course. So, before founding Filament, my team and I operated and sold Mazza Innovation, a venture-backed startup that pioneered a novel botanical extraction technology. We developed an expertise in GMP manufacturing and standardization through that business. Given our personal interest in psychedelics and mushroom cultivation, Filament was the next step.

We launched Filament to fill a gap in the market for pharmaceutical-grade, naturally derived psychedelics. Our hypothesis was that consumers inclined towards natural products in other areas of their lives would likely prefer naturally sourced psychedelics, as well. It felt like the perfect opportunity to bring our unique skill set to an emerging market where we could potentially help millions of people around the world.

It’s not just about consumer preference, either. We also believe in the intrinsic benefits of complex natural products, which contain multiple active compounds. These “entourage effects” might improve therapeutic outcomes or reduce side effects compared to synthetic alternatives. We think that’s worth exploring. By harnessing the full spectrum of compounds found in psilocybin mushrooms, our goal is to demonstrate the advantages of a more holistic approach to psychedelic medicine.

Filament’s focus on natural, botanical medicines sets you apart from other psychedelic drug development companies. What do those terms mean exactly, and how did you land there?

The distinction between natural and botanical substances is meaningful, especially in the context of drug development. A “natural” product is simply derived from nature, such as psilocybin extracted from mushrooms. However, a “botanical” drug, as defined by the FDA, maintains all secondary compounds alongside the primary one. From the regulators' point of view, a botanical drug is considered safer for clinical trials. They know people consume magic mushrooms, so there’s some safety assurance there. Individual compounds, on the other hand, might have unknown effects in isolation.

Our process at Filament involves cultivating mushrooms in-house, drying and milling them into powder, and then extracting them with solvents. We've developed a unique purification method that retains minor compounds while removing inactive elements, allowing us to standardize our final product—PEX010—to contain a precise dose of psilocybin in each capsule. This meticulous approach ensures our product is not just natural, but botanical. It preserves the mushroom's full compound spectrum.

What sets PEX010 apart from synthetic alternatives—apart from its full-spectrum complexity—is that it comes from a specific genetic strain of mushrooms. We safeguard our product’s genetic source material as a trade secret. That’s why our botanical drug can’t be easily replicated and what gives us a competitive advantage.

Obviously, you can’t patent nature. Since your medicines are botanical, how do you think about defensibility and protecting your intellectual property?

Choosing to keep our mushroom strain a trade secret, rather than patenting it, is a strategic decision. What that means is we haven't disclosed the composition of our final drug product publicly, nor have we claimed exclusive ownership over it. The advantage of this approach is that it's more difficult for competitors to replicate our process or product. However, if someone independently decides to use the same strain, there's no legal mechanism for us to prevent them from doing so.

This approach mirrors successful precedents in other industries. A great example is Coca Cola, which has maintained a competitive edge through its secret formula for over a hundred years. When you file a patent, you get a temporary monopoly but eventually the innovation is released into the public domain. With a trade secret, we have protection indefinitely.

Moreover, our mushroom strain is only one part of a broader intellectual property strategy. To create the first standardized, natural psychedelic extract, we’ve had to invest heavily in research and development. We’ve set up a lab to analyze mushrooms, obtained the necessary licenses, and gained expertise in strain selection. This investment has resulted in a body of knowledge and techniques that we protect vigorously. We do hold patents on our technologies for extraction, purification, and standardization.

With synthetic drug production, companies can sidestep potential issues around over-harvesting and ecological conservation. What are you doing to protect the natural environment as you scale?

While it's true that synthetic manufacturing avoids direct harm to natural organisms, it's not without its environmental drawbacks. Synthetic processes are far from clean; they use harsh chemicals and produce often toxic waste. Natural production methods, especially for psychedelics like psilocybin, offer a more eco-friendly alternative. Our facility can produce a substantial amount of psilocybin in a relatively small space. In many cases, natural cultivation is more efficient and leaves a lesser environmental footprint.

That said, you’re right to be concerned about conservation. Sourcing natural psychedelics carries its own set of ethical, cultural, and environmental considerations. We're committed to sustainable practices, particularly when dealing with species like iboga or peyote, which are endangered or hold sacred significance to indigenous communities. For example, we strictly avoid using peyote or exploiting toads for their psychoactive substances. Instead, we source alternative plants like the San Pedro cactus, which can be obtained sustainably.

The key is to make sure we're neither depleting natural resources nor disrespecting cultural traditions. In the case of iboga, efforts are being made in Gabon to promote sustainable agriculture, which not only preserves the plant but also provides income for local communities. We want to ensure the longevity of these important species and their surrounding cultures, and we believe natural production can play a supportive role.

Outside your own drug development programs, Filament supplies botanical psilocybin to research partners behind the scenes. You also support Health Canada’s SAP. What are some of the projects you’re most excited to be a part of?

As you might imagine, there's a lot of demand for botanically extracted, GMP pharmaceutical-grade psilocybin, particularly when offered at minimal or no cost. Fortunately, we've been able to supply psilocybin through Health Canada's Special Access Program to hundreds of patients dealing with conditions like end-of-life distress and major depressive disorder. The impact of supporting these Canadians outside of clinical trials brings immense satisfaction to our team.

We also provide our psilocybin at little to no cost to qualified academic researchers worldwide. In return, we build strong relationships and gain insights into new therapeutic indications from ongoing studies in depression, PTSD, alcohol use disorder, opioid tapering, and other conditions. This collaborative approach not only enhances our understanding of psilocybin's effects across different patient populations but also amplifies our contribution to the field.

On the commercial front, we've established licensing agreements with several companies who are using our product, PEX010, to advance treatments in palliative care, cancer demoralization, and eating disorders. Meanwhile, we’re running our own Phase 2 trials for opioid and stimulant use disorders. Our operating philosophy is that psychedelic medicine needs to be made available as soon as possible. No single entity can explore all potential indications, so we've embraced collaboration as a strategy to make the greatest impact. What matters most is expediting patient access to these transformative treatments.

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DISCLAIMER: This newsletter is for educational and informational purposes only and is not intended as a substitute for professional medical advice. The use, possession, and distribution of psychedelic drugs are illegal in most countries and may result in criminal prosecution.