Throughout her career, Najla Guthrie has been hailed for both her revolutionary contributions to nutritional science and her accomplishments within the nutraceutical industry. Najla has published over 50 papers in peer-reviewed journals and has given numerous presentations at both the national and international levels. She has also acted as a founding shareholder for KGK Science, transitioning from a nutraceutical medicine researcher to President and CEO. Under her leadership, the company has successfully established and executed a novel strategic plan, one which leveraged its research infrastructure and financed the development of patented in-house products. She is responsible for the co-development of KGK’s Diabetinol and Dermytol, as well as the commercialization and licensing of Sytrinol. Additionally, Najla has brought KGK’s integrated research and product development team to a world-class level, with the group receiving international recognition for its efforts in nutraceutical science and cannabis research.
What made you personally excited about psychedelics?
I’ve dedicated over 3 decades now to studying natural compounds, developing novel products and helping companies support their products with science. Of course, the fact that many psychedelics are of botanical origin piques my interest but more so, it’s incredible to see the science supporting the anecdotal and traditional evidence for the use of psychedelics as medicine. After the initial research from the 50’s and 60’s was shelved, the effectiveness of psychedelics for mental health was limited to anecdotal reports and intermingled with entheogenic use.
Until fairly recently the understanding of psychedelics in an empirical sense has very much been restricted. I think it’s exciting to see compounds with such profound effects finally overcome the political barriers and social stigmas and come for the forefront as a potential solution for the mental health crisis.
The fact that psilocybin can reset the brain is fascinating. The development of psychedelic medicines is likely to open a wealth of information about human brain function that may otherwise have remained unknown. The clinical results so far are very robust and there is so much promise across many indications that haven’t really been properly evaluated yet.
What does KGK Science do?
KGK Science Inc. integrates scientific, clinical research, commercial, and regulatory expertise to deliver well-designed solutions for propelling health and wellness products to market. For over 24 years, as a leading contract research organization specializing in human clinical trials for the health and nutrition industry worldwide, KGK has applied the highest quality standards to clinical studies to demonstrate safety and support claims substantiation of natural health products, dietary supplements, medical foods, conventional foods, and a variety of natural over-the-counter products, functional foods & beverages, bio actives, cosmetics, cannabinoid-containing products and most recently psychedelics.
Our expertise in studying botanical health products naturally carries over to psychedelics and we are heavily focused on becoming the leading contract research organization of the psychedelic renaissance. The KGK mission is built on a foundation of scientific excellence, and we are committed to performing a positive, pioneering role in the future of integrative healthcare with integrity.
What are you working on within the Psychedelics Space?
We have found that many companies in the initial stages of product development find us to be an extremely important partner for helping them translate their vision into reality. A first step with many companies has been the combination of a Path to Market and Gap analysis for their product. Our in-house regulatory toxicology expertise is second to none. We have provided several psychedelic companies with these preliminary reports to arm them with the regulatory strategy for their commercialization plan, potential pitfalls and pre-clinical and clinical requirements to bring their product to market. Often these reports alert the client to several considerations that they were unaware of that present a risk or challenge to their commercialization strategy.
Many clients proceed to have our team design and manage the preclinical toxicity and proof of concept studies as the first stage of drug development. We conduct the animal work through our trusted partners, but our team represents the interests of the client and is very familiar with the company goals and development program.
We are currently providing these services to Psyched Wellness. Initially, they engaged with KGK to provide a toxicity review, Path to Market and Gap analysis for their Amanita muscaria extract. The project has proceeded with KGK designing and managing the conduct of a suite of preclinical toxicity studies which will support regulatory submissions to FDA and Health Canada.
Of course, we also provide full à la carte clinical research services. We design, conduct, and manage clinical studies from Phase 1 to Phase 4 and analyze the results providing an interpretive final report that is formatted to support regulatory submissions. We also provide writing and publishing services after the study is complete. We provide any portion of a clinical trial design and management as a standalone service as well as part of a comprehensive package. We are currently working on clinical trial designs for several types of phase I and II studies for both synthetic and naturally sourced psychedelic compounds. We also are fully outfitted to conduct virtual clinical trials which are a critical tool for gathering real-world data on the use of psychedelics through remote participation.
As we offer comprehensive services to assist throughout the entire drug development process, some of our clients almost consider us as an extension of their team. In addition to providing strategic advice for commercialization and the required scientific and regulatory services, we have also been assisting companies in sourcing and formulating their products as our extensive network in the nutraceutical and cannabis sectors provides ingredient sourcing and manufacturing services applicable to the psychedelic medicine industry as well. I foresee that many more partnerships will be announced over the coming year.
Can you tell us about some of the clinical trials you guys are working on that are focused on psychedelics?
We recently announced our partnership with Numinus Wellness on the design and management of a Phase I clinical trial for their proprietary psilocybin mushroom extract. This is a Phase I clinical trial that is very exciting as it is the first study of their proprietary psilocybin mushroom extract. The majority of the clinical trial data out there for psilocybin has been based on synthetic psilocybin as it is more straight forward from a regulatory and mechanism of action perspective when there is only one active component.
This study will be one of the first clinical assessments of a fungal extract which is very exciting. The so-called ‘entourage’ effect is very interesting and is unique to natural products. We are proud to be a part of it.
Although I cannot yet disclose many details, we are also working on an early Phase II proof of concept study for psilocybin in the treatment of PTSD. Anxiety and depression projects are also in the early stages. I’m also very excited about some of the indications that we are exploring for products containing psychedelic substances such as IBS, rheumatoid arthritis and fibromyalgia. These conditions are peripheral in origin but also have some nervous system and mental health components.
We are consistently approached with new psychedelic products that are being assessed in a novel indication or for viability from a regulatory perspective. It is a very fast paced and exciting industry at the moment. KGK will be working on many more Phase I and early Phase II studies as much of the industry is in the early phases of product development. Our clinic is located in London, ON, but the majority of our psychedelic clinical studies will take place at partner clinics outfitted for psychedelic therapy.
What scientific validation have you seen around psychedelic compounds that show therapeutic potential?
The data for psychedelic-assisted psychotherapy in the treatment of depression and PTSD is quite amazing. Even the most skeptic scientist can’t deny the benefits in these areas. I believe that the whole industry should be ecstatic about the results of the MAPS-sponsored phase III study of MDMA-assisted psychotherapy for PTSD that was recently published in Nature. These results were very robust and lend credence to psychedelic medicine as a legitimate therapy.
The imaging and connectome work that Kringlebach and others are doing is not only providing extremely interesting information but is giving us a glimpse into the potential mechanisms by which psychedelic compounds act and thus far seem to indicate wide reaching therapeutic potential. Thus far, the majority of clinical data pertains to MDMA and Psilocybin for PTSD and MDD but there are currently clinical studies being conducted in so many indications in the mental health sphere that the next few years are likely to see a wave of results come in.
The serotonergic system is so integral to our mental health but also to the experience of pain and other peripheral functions. Based on the traditional uses of psychedelics for other conditions such as rheumatism, it won’t be surprising to see indications of interest continue to expand. There are new studies being published every month that contribute in some way to demonstrating the potential for the benefits of psychedelics. The basic science is generating a lot of exciting data that is going to quickly be assessed with clinical research.
The initial pharmacological characterization of baeocystin is a valid starting place for the therapeutic potential of a compound derived from psychedelic mushrooms that may not cross the blood brain barrier. Another example is the study published last month that showed the antidepressant effects of psilocybin may be independent of 5-HT2a receptor activation. I believe that a clinical study of ketanserin in combination with LSD is currently in progress and I’m sure a psilocybin study will follow shortly. These types of basic science studies speak to the complexity of the effects of psychedelics and the need for human research.
Can you talk about some of the partnerships you have within the psychedelics space?
Some of our partners include E.I. Ventures, Nutritional High, Numinus Wellness, and Psyched Wellness. We have many more partnerships that are not yet in the public domain. You will see many more over the next year.
What do you see the future of psychedelic medicines being and what will their impact be on healthcare as a whole?
I think that there are going to be wide-reaching impacts. It will of course start with addressing the current mental health crises through a transformation of how people are treated for mental health conditions like PTSD and depression. The same pharmaceuticals are being used now as were used 30 or 40 years ago; but on a much grander scale. One in five people in Canada experience some form of mental illness in their lifetime.
At KGK, we used to exclude patients on antidepressants from participating in our nutraceutical studies analyzing a healthy population. This has changed since the prevalence of use is so high that the new normal or “healthy” must include people on a stable dose of antidepressants.
Psychedelic-assisted psychotherapy represents an incredible replacement for antidepressants and other currently standard and ineffective treatments. Not only is it a drug that is only taken occasionally, its effects are typically immediate and long-lasting providing improvements to quality of life in many ways. Treatment with antidepressants can take several weeks for effects to begin and chronic treatment presents far more risk to the individual and physical dependence can develop. Currently, the cost for psychedelic therapies seems like a real barrier for widespread implementation but I’m sure that will be overcome.
I think that microdosing holds a lot of promise for having a major impact in healthcare as the whole. The potential benefits of microdosing have not been confirmed at this point but if benefit exists, I think we will see the applications for psychedelic treatments greatly expand. Removing the psychedelic experience from the treatment will also result in more widespread acceptance from the general public.
What do you believe is the most important thing for people to understand about the future of psychedelics as medicine?
I think that it’s important for people to realize that for psychedelic medicine to reach its full potential, a lot of clinical validation is going to be required. While the use case for treatment resistant cases of PTSD and MDD is strong as there is no effective conventional treatment. Widespread implementation of psychedelic therapy for typical depression and other common mental health issues is going to require strong scientific support to justify the regulatory repeals and changes to treatment paradigms required.
The landmark MDMA and psilocybin clinical trials have set the stage but if the industry is to succeed a very strong case will need to be presented to regulators. This is critical because psychedelic therapies hold great potential benefit for society that is rooted in accessibility and acceptability. The clinical data not only convinces regulatory bodies but society in general.
Many of those who are unfamiliar with psychedelic treatments either believe that it is just an excuse to get people high and psychedelics are narcotics. Others have heard bits and pieces and believe that simply taking a high dose of psilocybin cures PTSD. They don’t understand the context and the power of the drugs when used in combination with psychotherapy. Properly educating the public is crucial and requires partnerships between government industry and academia.