Real World Evidence (cover) by Psychedelic Stock Watch is licensed under
- Formal drug development through clinical trials is a long and expensive process
- As the Mental Health Crisis spirals out of control, people need access to psychedelic-based next-generation mental health therapies today
- How RWE drug development can accelerate the Psychedelics Revolution
The Mental Health Crisis is a healthcare catastrophe in desperate need of a solution: psychedelic medicine.
The problem in supplying this solution – via the emerging public companies in the psychedelic drug industry – is twofold. First, drug development via the clinical trials model is a very slow and very expensive process.
Secondly, the current irrational and obsolete classification of these drugs as Schedule 1 substances (that supposedly have no accepted medical uses) is further slowing down drug development.
MAPS is in the process of repeating its very successful Phase III clinical trial on an MDMA-assisted therapy for PTSD. It’s forced to do the trial twice because of FDA rules regarding Schedule 1 substances (the most-restrictive classification).
Meanwhile, every day of additional delay in getting this therapy approved, another 22 U.S. veterans will commit suicide due to their poorly treated PTSD.
Wouldn’t it be nice if there was a different “path” to drug development (and approval) that was not only faster and cheaper, but allowed commercialization to begin concurrent with development?
Present that teaser to an investor in psychedelic stocks and there would likely be two responses:
a) Sounds too good to be true.
b) There must be a catch.
b) There must be a catch.
In reply to that: (a) no, it’s not and (b) yes, there is.
Real World Evidence Drug development
Separate from the formal clinical trials that is pursued almost exclusively in North America is Real World Evidence (RWE) drug development.
It is faster, it is cheaper, and thus it is a much more efficient drug development pathway. And it allows the drug developer to begin to scale up commercialization/distribution while the actual testing of the drug takes place.
Why have most U.S. and Canadian investors in psychedelic stocks not already heard about RWE drug development? Because it is a drug development model that (currently) is almost exclusively employed in the UK and EU.
And there is a catch.
In order to qualify for this expedited pathway to drug development (and drug commercialization), the drug candidate in question must satisfy two rigorous criteria:
- A proven, safe substance;
- Addressing an urgent and unmet healthcare need.
Fortunately for psychedelic drug companies, and the two billion people globally with treatable (but untreated) mental health disorders, several psychedelic drugs clearly meet these criteria. Psilocybin, LSD and MDMA are arguably the strongest candidates for RWE drug development.
As Psychedelic Stock Watch noted in a recent article, the safety of these particular psychedelics is one of the strong points in favor of expediting drug development.
Even in the formal clinical trials model, the safety of psilocybin, MDMA and LSD is helping to accelerate development. It is allowing the FDA to bestow its Breakthrough Therapy Designation on some of these trials – confident that this fast-tracking won’t lead to safety concerns.
For RWE drug development, such safety is not merely desirable. It’s mandatory.
Likewise, there is obviously an urgent and unmet need for these psychedelic drug-based therapies.
Two billion treatable disorders (roughly 1 out of every 4 people) represents about as urgent a health pandemic as we will ever see. And these two billion mental health disorders are leading to 8 million preventable deaths each year – because existing therapies are grossly inadequate in meeting the needs of patients.
In the United States, 2 out of 3 people exhibiting symptoms of depression don’t even seek treatment – because existing therapy options generally produce such mediocre results.
With PTSD, 2 out of 3 veterans attempting to get treatment by the Department of Veterans Affairs reports no benefit from their PTSD therapy.
This gross failure in treating PTSD has led to more than 115,000 veteran suicides over the past 20 years.
With cigarette smoking, 2 out of 3 smokers want to quit, but can’t, because existing “smoking cessation” products are inadequate to break the powerful addiction of nicotine.
This leads to ~500,000 U.S. deaths every year.
Clinical research of psychedelic drug therapies is showing the clear potential to cure all of these disorders.
Obviously, RWE drug development is a vehicle to allow public companies to get these new drug therapies to market faster and cheaper. It is also a potential means to save a lot of lives.
UK and EU using RWE to expedite drug development
The RWE pathway isn’t merely some regulatory fine-print that has no actual application in the “real world”. One psychedelic drug company that is currently pursuing RWE drug development is UK-based private company, Albert Labs.
Albert Labs is preparing to close its CAD$4 million series A round in anticipation of going public later this fall on the CSE. In speaking with management, Psychedelic Stock Watch learned that European drug companies utilized the RWE pathway to expedite development and delivery of some of their Covid vaccines.
These drug multinationals didn’t especially need the cost savings implied by the RWE pathway. But they were very interested in the speed factor. And we’ve all seen how well this vaccine development has played out commercially for the big drug companies.
Dr. Michael Raymont, CEO of Albert Labs, connected the dots for investors on how RWE drug development is a “win-win” for the whole industry.
“Because the RWE pathway for regulated drug approval is much faster than a traditional RCT (Randomized Clinical Trial), urgently needed drugs can get to market quickly, which is a huge benefit for suffering patients. At the same time, the cost of an RWE trial is very modest compared with RCT’s, so smaller drug development companies with modest financial resources can finance their own trials. As a direct consequence of faster approval and lower costs, companies using an RWE approach can generate revenues and profits more quickly, which is good for growth and further development. It’s all about speed to market. It’s a win-win for all stakeholders, patients and investors.” [emphasis mine]
Some of the public companies based in the UK or EU and pursuing psychedelic drug development still prefer to work their way through the more formal (and better known) clinical trials process. Compass Pathways (US:CMPS) would be an obvious example.
However, not all of the public companies operating in this space can regularly raise capital in increments of $100 million or more.
For drug developers with greater budget constraints, RWE doesn’t merely represent a faster pathway. It’s also a much easier business model to fund.
Is RWE the future of psychedelic drug development?
As already noted, psychedelic medicine is the future with respect to mental health care. Is the RWE pathway to psychedelic drug development the future of psychedelic medicine?
Thanks to the Covid-19 virus, the Mental Health Crisis – which was already a pandemic in its own right – is now spiraling out of control.
President Joe Biden and the sleepy senior citizens of Congress seemingly see no sense of urgency in bringing archaic drug laws into the 21st century. Congress recently voted 331 - 91 against even allowing the federal government to study psychedelic medicine.
Meanwhile, people continue to die.
The United States is now in its eighth year of a Suicide Epidemic. On average, one American commits suicide every 10 minutes.
The U.S. is also in the midst of a Drug Overdose Epidemic, which (thanks to Covid lockdowns) soared by 30% in 2020. One American dies via drug overdose, on average, every five minutes.
For investors in psychedelic stocks, and the psychedelic drug companies themselves, there is great commercial potential in getting these drugs to market as soon as possible.
A huge medical need. A huge commercial incentive.
Psychedelic drugs will revolutionize the treatment of mental health – eventually. Real World Evidence drug development can help to accelerate this Revolution.
