Latest Research: CBD-Based Alternative to Steroids/Autoimmune
Video interview: exploring the potential of CBD-based medications in treating inflammation and as an alternative to steroid medications
A couple of weeks ago, I had the privilege of joining forces with my favorite pharmacist Dr. Megan (aka The Prednisone Pharmacist), and interviewing David Bassa, a seasoned entrepreneur with an impressive track record of building and selling companies.
Although not a scientist by trade, David owns several pharmaceutical and drug development companies and led the first-ever Israeli ‘exit’ relating to cannabis pharma.
Uncovering the Benefits of CBD-Based Medications for Treating Autoimmune Conditions
We gathered to discuss the future of CBD as a substitute for steroids (e.g., Prednisone) or as a supporting medication for conditions that involve inflammation within our bodies, like autoimmune conditions.
This topic is extremely close to my heart since my success with CBD (or rather Broad Spectrum CBD oil) helped alleviate my Rheumatoid Arthritis and eliminate the need for Prednisone after 23 years straight.
My personal success was also the inspiration for me to found Reclaim Labs , with the goal of sharing my success and experience with fellow patients suffering from autoimmune conditions, various inflammations, and more.
So, for me, this interview with David’s fascinating input on the latest development with using CBD in treating an array of diseases was proof I am not completely crazy, and that CBD holds some mega potential in being introduced into our world’s CBD-skeptic pharma companies and have a major effect in changing patients' lives.
Now, let’s get to the really interesting stuff...
STERO Biotech - an early mover in uncovering CBD potential in treating autoimmune conditions
David started the interview by stating the mission statement of STERO Biotech, one of his recent ventures: “steroid-sparing”, with the goal of reducing the side effects through steroid-sparing, helping long-term steroid patients enhance steroid treatment.
STERO, in fact, has an approved patent for using its solutions to decrease or completely eliminate the need for steroids in various diseases.
A cancer story turning into revolutionary discoveries
David told us what actually got him, a high-tech person, into pharma - his mother’s cancer diagnosis. While she was sick, David invested a lot of his resources into researching CBD-driven solutions that could benefit his mother. This research eventually formed into a company, Talent Biotech, that later got acquired by Kalytera, a pharma company that plans to advance its GvHD program into FDA phase 2 clinical trials.
While running clinical trials around GvHD under David's Talent Biotech in the Rabin Center in Israel, the participating physicians noticed that while using their CBD-based formula, they saw an 80% decrease in the need for steroids. And David, driven mainly by his mother’s will which instructed him to continue and help people, sensed an opportunity that turned into another IP and another company - STERO.
Based on that steroid-related success, David and his partners wrote an IP that was approved in the US on August 2018, and since then STERO has started running various clinical trials specifically related to CBD vs. steroids in multiple hospitals in Israel across various inflammatory conditions.
The IP itself is very inclusive and covers any CBD combination, including delivery systems, and covers over 150 diseases for which steroids are used as a treatment.
The goal of creating a real FDA-approved CBD-based medication
When I asked David what was the process of getting the IP approved, his first reaction was “deep pockets. Maybe $50M-$100M”. It would have been much easier to simply sell it as a wellness product and make those vague statements of – it supports, or it may help, but this is not STERO’s goal.
STEROs goal is to create actual medicine from its technology, and for that, they need to go via the FDA route, which requires many many clinical trials.
So far, STERO has performed 4 clinical trials, but in order to pass as a conventional medicine they’ll need at least 3-4 more trials of phase 2, and then phase 3, which means millions of dollars more.
So David’s goal is to license STEROs products and IP to a major pharma player with deep pockets to get it FDA-approved. But here’s where it gets even more tricky.
Are big pharma players really open to engaging with cannabis or CBD?
I challenged David asking him if the big pharma companies are really open, or ready to engage with cannabis/CBD.
To David’s point – the scouts of those pharma companies are excited about such new CBD-based drugs, but those companies still treat CBD as an illegal solution. And while this might be correct federally when it comes to plant-based CBD, this is not the case with synthetic CBD that is produced in labs.
In fact, there is already an epilepsy medication called EPIDIOLEX that was approved by the FDA, and despite the fact that this medication was approved over 2 years ago, up until around two weeks ago large-scale R&D relating to cannabis was still banned in the US.
However, two weeks ago, Biden signed a “Medical Marijuana and Cannabidiol Research Expansion Act” which allows such R&D in the US. That’s huge progress because Biden was always promoting these bills in congress but getting to a dead end in the senate. But now, he succeeded in successfully passing the R&D part. However, there are still other parts of the bill that need to be passed to completely take cannabis outside the illegal drug status. Let alone when we are talking about synthetic CBD.
Advancing CBD-based R&D and clinical trials
Since in Israel cannabis R&D is allowed, in the past 10 years, STERO has gained a lot of know-how in the field of CBD-based treatments, and much of that is thanks to STERO’s clinical trials partners. In fact, STERO partnered with CLALIT HMO (Health Management Organization), which is the largest of its kind in Israel. consider it as the Israeli version of Kaiser Permanente. CLALIT has 14 hospitals, about 12,000 physicians, and 5 million members (which is 50% of the entire Israeli population). STERO had access to all those resources to drive and support its clinical trials.
In terms of clinical trials, as mentioned above, there was already a CBD-related clinical trial focusing on GVHD. There are active clinical trials around lowering cholesterol, and around lowering triglycerides. There are also active clinical trials around Ulcerative Colitis and Crohn’s, and two additional clinical trials that will take place soon, one around peripheral neuropathy and the other around bronchiolitis obliterans.
So to our point, talking about steroids, advanced CBD solutions can, in certain conditions replace the need for steroids, and in other conditions, enhance and support steroid treatments.
How CBD works with the immune system
Through all those trials, STERO’s researchers got a deeper understanding of the mechanism of action of CBD and how it helps support the immune system. On one hand, CBD calms the immune system and on the other hand, CBD decreases inflammation.
David mentions that every week they get requests from patients on how they could buy their solutions, but at this stage, he doesn’t have the answer they are looking for since he cannot sell those yet. And this is exactly where a big pharma partner will come into effect.
What about the safety of CBD and its related solutions?
Is there any condition that STERO’s solutions are not recommended for?
As David states, in any clinical trial, one of the main objectives is to support the drug’s safety profile, and a good safety profile was demonstrated in about 250 patients with various conditions. In fact, the FDA regards CBD as safe.
With over 130 autoimmune conditions, will STERO’s solutions be inclusive of all?
According to David, the ratio is roughly 70:70, which means 70 autoimmune conditions and 70 infectious conditions. All those are defined specifically in their IP. But any autoimmune disease or infection is covered by their IP and can be used with their solutions (e.g., Myasthenia Gravis, COPD, asthma, FMS, etc.). Of all those, David says that roughly 10% of the patients are using steroids permanently.
Well, I can definitely attest to the efficiency of my CBD oil formula in both alleviating my Rheumatoid Arthritis, and even more astonishingly, allowing me to go off steroids after so many years.
Of course, I had to ask David about clinical trials with Rheumatoid Arthritis, how can I not? The answer is no, there were no clinical trials with Rheumatoid Arthritis yet, but it’s definitely on the list. Well, in a way, I am already a part of this real-life CBD clinical trial of mine.
I warmly recommend watching the full video interview since there’s a lot more information there on future research, delivery methods, and more.
My Personal Take
But here’s my personal take on the topic, in a way, this whole process of fighting the legal system in order to get cannabis and cannabis research legal just to get R&D and clinical trials going is somewhat artificial. I mean, cannabis and CBD are not new things and have been consumed by individuals for hundreds and hundreds of years.
Specifically, CBD has already been proven to help with various conditions and with fighting inflammation. So, in essence, humanity has already performed probably hundreds of thousands of informal clinical trials. The only problem is that these were not documented, and in a regulated world like ours, formal data is key to progressing science. I guess only time will tell.