Bionxt Solutions is diversifying into psychedelic medicines by launching Bionxt Laboratories.
Among the leading contenders in the race to pioneer new blockbuster psychiatric drugs is Vancouver-headquartered Bionxt. This small opportunity-driven life sciences accelerator operates a range of R&D projects in both Canada and Germany.
They include Bionxt’s new psychedelics division. The company’s near-term focus entails the formulation of psychedelic compounds – such as psilocybin derived from various psychoactive mushrooms and mescaline derived from peyote and other cactus species – into mood-improving and therapeutic pharmaceutical drugs.
In particular, its expertise in using sublingual and transdermal therapeutics to deliver precise dosing of very dose-specific drugs, like fentanyl, will prove invaluable in this opportunity-driven undertaking.
Leading the way with German pharmaceutical expertise
Bionxt’s psychedelic research is led by Professor Raimar Löbenberg. Although he developed his professional expertise in Germany, he is now one of the few medical scientists working in North America who has the necessary government-level clearance to develop experimental pharmaceutical psychedelic drugs in a leading university laboratory.
Löbenberg’s Health Canada licences for research and analytical testing allow him to work with LSD, psilocybin, MDMA, and other psychotropic molecules.
Professor Löbenberg explains: “Our initial focus is to develop standardised drug formulations with precise, predictable, and efficient delivery of their active pharmaceutical ingredients for clinical study and therapeutic use. We see a lot of potential therapeutic value in psychedelic compounds for their ability to positively influence neural networks through growth and reorganisation.”
As a founder and director of the Drug Development and Innovation Centre at the University of Alberta and the former president of the Canadian Society for Pharmaceutical Sciences, Professor Löbenberg is a hard-nosed scientist with many years of expertise in pharmacology.
In addition to Dr Löbenberg’s laboratory, team, and drug development expertise, one of the company’s German subsidiaries – Vektor Pharma TF GmbH – has globally recognised drug delivery technology and manufacturing capabilities. Vektor specialises in the use of proprietary oral/transmucosal strips to optimise the uptake of orally administered drugs.
It is well worth noting that most drugs that are delivered via this method are shown to have especially high bioavailability. They also provide a faster onset and more predictable level of efficacy because the drug does not need to be metabolised via the liver. Dosage-control will be vital to the judicious administration of such powerfully potent drugs as psychedelics, Professor Löbenberg adds.
“Bionxt intends to first produce psychedelic active pharmaceutical ingredients, which can then be incorporated into our novel sublingual and transdermal delivery systems. This is our competitive advantage, from production of API to drug formulation to clinical validation,” he said.
In this regard, Bionxt is doing pre-clinical laboratory work with a focus on the following psychotropic compounds: psilocybin, mescaline, LSD, MDMA, and DMT.
All of these mind-expanding compounds are known to modulate neurotransmitters such as serotonin and dopamine, which regulate cognition, perception, and mood. This makes them well suited to treating a variety of mental conditions, which also include post-traumatic stress disorder (PTSD), according to several early-stage clinical trials.
Why society so desperately needs psychedelics
There have been few meaningful advances in the development of psychiatric drugs since the late 1980s. This was when selective serotonin reuptake inhibitors (SSRIs) – the healthcare industry’s go-to antidepressant of choice – were first commercialised.
Yet antidepressants fail to help up to 30% of those prescribed. And they can be highly addictive among people who do find them therapeutic. So, according to many mental health experts, the arrival of a new paradigm in breakthrough psychiatric drugs is long overdue.
Nonetheless, annual sales of antidepressant drugs keep surging higher every year. They currently total more than US$14bn, according to a study by Allied Market Research. Other estimates range as high as US$50bn worldwide.
In total, anxiety disorders and/or persistent depression affect up to 25% of the population in Europe, and a similar percentage of people in the USA. That is 250 million people combined – the majority of which experience chronic anxiety. Yet they are commonly treated with anti-depressants due to a scarcity of effective medicine to treat people with frayed nerves.
As to whether psychedelics represent a prospectively better alternative, the public perception has always been that any therapeutic value they may have is outweighed by the dangers that they supposedly pose. However, 21st century observational studies conducted by healthcare professionals in controlled environments have consistently shown that participants have reported few or no negative side effects. Studies also show that psychedelics have low potential for abuse or dependence.
According to drug-harm experts, the psilocybin in psychoactive mushrooms, mescaline in certain cactus, as well as the synthesised compounds in LSD and MDMA, rank among the least harmful drugs when factoring-in damage to health, drug dependency, economic harm, and the societal cost of crime.
Then there is a whole array of other anti-psychotic medications that might one day be replaced by psychedelics. As previously mentioned, the mental health market is worth an estimated $70bn a year globally, according to Bloomberg. Psychedelics stand to earn a sizeable share of this enormous market.
Disrupting mood drugs: a new multi-billion dollar market
The market intelligence firm, Data Bridge Market Research, forecasts the psychedelic pharmaceuticals market could grow to almost $7bn by 2027 from almost a standing start. Meanwhile, a prominent Canadian investment bank, Canaccord Genuity, estimates that this nascent industry could eventually be worth $100bn.
Not surprisingly, Big Pharma is already beginning to get serious about this new frontier of medical science. After all, the industry has made massive profits from the sale of SSRIs while also becoming increasingly sensitive to the dangerous drawbacks of these controversial drugs.
Hence, an opportunity to help launch a new generation of more effective, yet less problematic mental health drugs must seem very appealing. Which is why Big Pharma will be keenly watching the progress of these biotech innovators in psychedelic medicine with a view to acquiring the best of the bunch for big-dollar sums.
Psychedelic drugs have at last shrugged off the stigma of the 1960s and are finally coming of age as a highly disruptive form of medical therapy. Besides a diversity of mental health ailments already mentioned, psychedelics are proving in observational trials to be especially effective at treating drug and alcohol addictions, too.
Additionally, they are even being developed to treat chronic pain and to help cigarette smokers quit for good. All of this means that up to two billion people may eventually benefit from access to these non-addictive, non-toxic, new drugs.
In summary, Bionxt has entered into two psychedelic agreements: first, for the development of industrial scale biotechnology processes for the production of psilocybin, and second, for research and development related to multiple psychedelic compounds, including psilocybin, mescaline, LSD, MDMA, DMT, among others.