Psychedelics in Lieu of Traditional Meds for Mental Health

Filament’s mission is to see safe, natural psychedelics in the hands of everyone who needs them, as soon as possible

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    The psychedelic stock sector is beginning to boom, with legalization efforts initiated worldwide for a variety of different alternative medical treatments from this category. Investors want to know more about the psychedelic stock investment opportunities from industry-leading experts.

    Today, we chatted with Benjamin Lightburn of Filament Health. As the Co-Founder and CEO of Filament Health, Lightburn leads a clinical-stage exclusively natural psychedelic drug discovery company. Filament Health is on mission to see safe, natural psychedelics in the hands of everyone who needs them as soon as possible. 

    Schaeffer's: What is so special about psychedelic medicine that makes you passionate expanding its legalized usage?

    Benjamin Lightburn: Simply put, it is the potential efficacy of psychedelic medicines, especially as it pertains to mental health conditions like depression, PTSD, and addiction, amongst others. We see early clinical evidence that outcomes could far surpass those of traditional treatments, or that these medicines might be efficacious against conditions that have no existing treatments at all.

    We have never seen a class of substances that have been so widely used for self medication, yet had illegal, controlled substances classification. So, providing a much wider section of the population with access to these medicines – in a safe, standardized, and legal way – is something worth putting blood, sweat, and tears into.

    Schaeffer's: As a major player in the psychedelic medicinal industry, why should patients suffering from various ailments consider psilocybin and other psychedelics in lieu (or in addition to) traditional medicine?

    Benjamin Lightburn: Taking depression as an example, SSRIs are, in general, poorly tolerated, relatively ineffective, and require people to try multiple courses before finding one that works, if one does at all. Whereas, as we saw with the COMPASS Pathways results, one single treatment with psychedelic medicines can provide potentially durable, antidepressive effects with none of the associated side effects of SSRIs.

    Obviously, a lot of research still needs to be done around the combination of psychedelics and traditional treatments. This is not very well studied, so we should not advocate for people to make these treatment combinations without consulting with medical professionals – but, psychedelics do show a great deal of promise in this area.

    Schaeffer's: What stigmas and social barriers do you feel need to be broken down for broader acceptance of psychedelics?

    Benjamin Lightburn: Psychedelics have documented use in humans over hundreds, if not thousands of years. They have been commonly used by societies around the world. Over time, beginning with the Western, Christian invasion of Mesoamerica and culminating in Richard Nixon's War on Drugs, we have been faced with an unfortunate stigma around drug use in general, and this of course applies in particular to psychedelics.

    This is a terrible thing, because we have not only heaped negative connotations on top of traditional spiritual practices, but we have introduced a massive barrier to widespread adoption of these substances, which show great promise as safe and efficacious medicines. 

    We need to shine light on this disparity, to get it out in the open, and to ask for hard evidence and data to support negative positions instead of allowing them to exist solely based on personal opinion. It is only through open dialogue that we can normalize this issue and begin to break down social barriers. Talking about these things can reduce the stigma and increase acceptance among those who may have previously shown reluctance.

    Also, many of us have to remember that viewing this topic through the lens of the psychedelics industry – being part of the group who advocates for the adoption of psychedelic medicines – inherently means that we are surrounding ourselves with people and information that supports our personal long-held beliefs. In this industry we are part of a self-selected minority, with whom the majority might not agree. We need to remember that it is just as important on our side to listen openly to alternative viewpoints and be wary of our own biases. 

    Schaeffer's: Tell me more about the FDA studies you are conducting currently and please share any promising preliminary results.

    Benjamin Lightburn: Filament Health’s three leading botanical drug candidates PEX010, PEX020, and PEX030 are set to be administered in FDA clinical trials beginning in early 2022.  PEX010 is a standardized 25 mg dose of natural psilocybin designed to provide the standard clinical dose. PEX020 and PEX030 however, are standardized doses of natural psilocin delivered orally and sublingually, respectively. They are stable by virtue of Filament’s own unique, natural process.

    Our recent FDA approval to administer these drugs into a Phase I clinical study is significant because it is the first such approval for natural psilocybin. In addition, it is the first such approval for the direct administration of psilocin. Studying psilocin could bring a number of exciting potential benefits which we will study in this trial, such as faster onset, shorter duration, more consistent dosing, lower gastrointestinal side effects, and an improved delivery method.

    We expect to be able to share exciting updates on this and other planned trials over the coming months.

    Schaeffer's: What psychedelic studies done by other researchers have inspired your company’s work and/or further validated your mission statement?

    Benjamin Lightburn: Recent studies from individuals like Robin Carhart-Harris and groups like COMPASS Pathways have proved promising and have certainly validated our mission. In addition to looking at clinical trials performed by modern researchers, the unique thing about Filament is that we can draw upon the vast library of established safe usage by modern humans and ancient societies alike, since we are studying naturally-derived compounds. Throughout history, only natural products were consumed and had their usage documented. In drawing upon this information we are thankful for all of the work and learning we are able to glean from cultures around the world.

    Schaeffer's: What are possible pathways to approval and which allow for the greatest possibility of widespread adoption?

    Benjamin Lightburn: Right now though, the pharmaceutical path is the only established way forward, so this is the route we and nearly all others are pursuing. It is very possible that a non-pharmaceutical distribution model will emerge and we think that will be important for widespread adoption, though we don't know exactly what it will look like. We may see some sort of broadening of this model in some jurisdictions in the short-term, like in Canada for example, but again, we are not quite there yet.

    Many pharma-focused companies in the space are wary of a non-pharma model, as it could mean them being undercut - why would a consumer pay thousands of dollars for pharmaceutical administration when they could go to a market like Oregon and pay a fraction of the price? 

    Legalization, marketing, and distribution roll-outs will take time and require competent management on the side of participating companies. Not every company we see today is going to survive, especially those who are here for a quick flip or quick returns.

    Schaeffer's: Please describe current industry IP trends and why this area is important.

    Benjamin Lightburn: Many companies operating on the drug development side of the psychedelics industry are able to claim patent protection for their products by creating new molecules based on known psychoactive compounds. Things found in nature cannot be patented, nor can their psychoactive ingredients, so the creation of synthetic analogue in a laboratory setting is the primary way many organizations are able to pursue exclusivity on a drug. 

    Another possible route to exclusivity is to patent transformative technology or processes developed to yield natural products. Obtaining IP around methods of manufacture, starting with generation one compounds that have documented safety and efficacy is the route we have chosen at Filament Health. 

    This area is important for protecting shareholder value, establishing a foothold in a new market, acting as third-party validation for an organization’s talent for innovation, and for providing security that operations won’t be interrupted by an IP offensive by a competitor. 

    Schaeffer's: Finally, tell us more about Filament Health, please.

    Benjamin Lightburn: Filament’s mission is to see safe, natural psychedelics in the hands of everyone who needs them, as soon as possible. We believe that natural psychedelics will provide the optimal route to widespread adoption of these healing substances due to the advantages they provide in the drug discovery process, in intellectual property protection, and in their versatility and desirability across both pharma and non-pharma markets.

    Natural extraction is the best way to access the untapped drug discovery potential of hundreds of psychoactive plant and fungi species. We will be conducting the first and only FDA clinical trials to date using naturally-derived psychedelics (Phase I enrollment in Q1 2022), as well as the first and only FDA clinical trial studying the efficacy and safety of direct psilocin administration.

    As there are finite viable ways to extract and purify naturally-occurring psychedelic compounds, extraction patents offer protection that synthetic patents do not – our team at Filament holds a portfolio of twenty extraction process patents filed, including the first ever patent granted for the standardization of natural psilocybin and associated psychoactive compounds.

    An in-house GMP manufacturing facility, via our wholly-owned subsidiary, Psilo Scientific, plus Health Canada Dealer’s License to propagate, extract, produce, and distribute all-natural GMP-grade psychedelic compounds, allows us to not only identify and produce the most promising psychedelic drug candidates to enter into our own clinical trials, but to generate near-term revenue by developing a network of exclusive licensing partnerships, such as our first, recently-announced agreement with EntheoTech.

    *This article is published for purely informative purposes. Filament Health's opinions are not necessarily a reflection in any way of those of Schaeffer's Investment Research. We publish information about companies in which we believe our readers may be interested. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalized advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as SIR's solicitation to effect, or attempt to effect, any transaction in a security. Investments in the securities markets, and especially in options and futures, are speculative and involve substantial risk. The information that we provide or that is derived from our website should not be a substitute for advice from an investment professional. We encourage you to obtain personal advice from your professional investment advisor and to make independent investigations before acting on the information that you obtain from SIR or derive from our website.*

     

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