Calling All Derivatives; The Psychedelic Space Needs You

Ash Stringer

February 15th, 2021

Psychedelics, Top Story, Uncategorized

In 2020, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research approved 53 novel drug products, the second most clearances in a single year in 23 years, trailing only a record 59 in 2018. Amongst the new drugs, 58 percent were approved for rare diseases, maladies where patients have little hope due to a dearth of drugs available for their condition. Against the backdrop of the COVID-19 pandemic, it was a banner year for healthcare on this front. Continuing at the aforementioned development pace requires the discovery of new modalities as scientists pursue all avenues to conquer a battery of unmet needs that still loom.

Beyond the rare, or so-called “orphan” indications, many other diseases that affect tens of millions of people every day remain a detriment to quality of life (and the healthcare system). These include conditions like post-traumatic stress disorder (PTSD), obesity, anorexia, anxiety, Alzheimer’s disease, addiction, and many more. Unfortunately, those afflicted with these types of ailments typically are left with options that only manage the symptoms (if at all), rather than address the root cause.

To many, psychedelics could be an answer to their unmet medical need. Historically, classic psychedelics, including psilocybin, ketamine, DMT, MDMA, and others, have demonstrated great promise in the treatment of brain and mental health conditions. Research was halted in the 1970’s by the passage of the Controlled Substance Act, however, the psychedelics space is experiencing a resurgence, owing to the recognition that these molecules could bridge gaps in healthcare. As such, there is a growing pool of investment dollars supporting organizations aiming to make the next big breakthrough.

Classic psychedelics, coupled with therapy have shown the potential to treat a vast range of indications. However, these molecules in their original form may not be the best option for every disease. For instance, treatment sessions can take up to 8 hours, adverse side effects (aka “bad trips”) are possible and the treatment can only be administered in a clinic. Simply put, what if there was a way to improve on classic psychedelics? In a recent study in Nature, a non-hallucinogenic derivative of ibogaine was shown to have therapeutic potential.

There are additional examples including last year’s FDA-approved nasal spray SPRAVATO® (esketamine), a product of Johnson & Johnson (NYSE: JNJ) subsidiary Janssen. This product is the chemical cousin of the psychedelic ketamine, which is used to treat depressive symptoms in specific adults with major depressive disorder. While still a symptom moderator, it speaks to the opportunity for psychedelic molecules and their derivatives.

Derivatives have the potential to bridge these shortfalls, making the addressable market much larger. Successful derivatized molecules from classic psychedelics could, amongst other things, enhance safety profiles, allow for outpatient treatment, shorten pharmacokinetic activity durations and allow for a wider treatment window.

“By creating new molecules, new therapeutics can be developed to more specifically treat a variety of conditions and existing treatments can be improved, which means that more patients can receive effective care,” said Dr. Peter Facchini, Chief Scientific Officer at MagicMed Industries Inc. (CSE: MGIC reserved), in a phone conversation with CFN Media. Dr. Facchini, who has published over 160 scientific papers and holds, or has applied for, more than 40 patents covering the production of naturally occurring pharmaceuticals and their derivatives, has turned his focus to psychedelics as a co-founder of MagicMed. The company is engaged in pioneering work on the creation and patenting of psychedelic analogs in a collection they call the “Psybrary™.

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The plan is for MagicMed to amass a large, patent-protected collection of novel derivatives based on classic psychedelics, using in-house trade secrets and proprietary scientific tools. From there, strategic partners are able to search, test, and further tailor their analogs of choice from the Psybrary™ for further development in conjunction with MagicMed.

While natural psychedelics such as psilocybin and DMT may ultimately turn out to be a perfect solution for certain types of treatment-resistant depression, what about less extreme forms of the disease? What about different types of addiction or different levels of anxiety? How about early-onset or late-stage Alzheimer’s? How will this affect patients with comorbidities? If it works on serotonin receptors to treat obesity, can it treat anorexia too?

“Nature is the source for many of our most effective medicines, but in virtually every case the natural product has been modified to increase its efficacy and/or safety and to create a pharmacopeia of related, but different, drugs that can be best matched with a patient’s condition and personal physiology,” said Dr. Facchini.

This is a “time will tell” scenario that is de-risked, or at least backstopped, by plenty of laboratory, clinical and anecdotal evidence that points to natural medicines as prime candidates for new categories of medicine for hard-to-treat diseases. In short, there’s hope where the outlook is all too often gray. For its part, MagicMed has recognized the dire need for something like the Psybrary™ and stepped up as a pioneer providing critical support to the psychedelics industry that is part-in-parcel to making novel medicines patients so badly need.

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