On February 28th, Cybin Inc. (NEO:CYBN, NYSE American:CYBN) presented data from its ongoing next-generation psilocybin clinical trial during the company’s R&D day.
The next-gen psychedelic, named CYB003, is a modified version of the classic psychedelic psilocybin, which Cybin believes will be more effective than the original in treating mental health issues such as depression.
Last year, Cybin launched the Phase 1 portion of a Phase 1/2a clinical study, testing the safety and tolerability of CYB003. This part has now been completed, and the initial data was presented at their R&D day. The company has since launched the Phase 2 portion, which will test the efficacy of the drug in treating Major Depressive Disorder.
Ever since CYB003 was first announced, Cybin has touted three core differences between the next-gen psilocybin and the original. Using animal data, Cybin claimed that CYB003:
- Is shorter-acting and has a faster onset than psilocybin
- Causes less variation in plasma levels between different individuals taking it — meaning that the effects would be more consistent across different people
- Can be administered at lower dose levels with the same effect
Up until now, however, we have had to rely on animal testing to show that these variations did in fact exist.
Now, with this initial data release, Cybin has shown that — in this first Phase 1 safety trial at least — all three differences are in fact present in CYB003 when taken by humans.
Each of these three changes have the potential to make CYB003 a more efficient and affordable medicine than regular psilocybin — assuming that it is equally as effective. Cybin expects to present efficacy data from the Phase 2a portion of the trial by the end of Quarter 3 of this year.
So, why is it important that CYB003 is shorter-acting, causes less variation in plasma levels, and can be administered at a lower dose?
To start, it is expected that psychedelic therapy, such as psilocybin therapy, will be extremely expensive when it is legalized. A large part of this will be due to the fact that a psilocybin experience can last between 6-8 hours. This means that a highly-paid therapist, and their support staff, will essentially need to be paid for a full day’s work for each psychedelic session.
This, obviously, would price out many patients who need help (assuming the costs are not covered by either the government or insurance).
In the Phase 1 part of their clinical trial, Cybin found that patients experienced a rapid onset action of the oral CYB003 dose, starting to feel the psychedelic effects within 15-30 minutes. They peaked within 90 minutes, and the peak lasted around 2 hours.
In other words, CYB003 shaved off perhaps two hours of time from a regular psilocybin psychedelic experience.
If Cybin finds that its medicine is equally as effective in treating depression, it would make their treatment hundreds of dollars cheaper per dosing session — though we will wait to see efficacy data before making that judgment.
It is important to note that Cybin tested four different dose levels of CYB003. They tested doses of 1mg, 3mg, 8mg, and 10mg, finding that in order to achieve “meaningful and robust psychedelic effects” they had to use at least 8 mg. Therefore the above times refer only to those on a large enough dose.
As for the plasma levels, as already stated, the fact that CYB003 was found to induce low variability between different individuals’ plasma levels means that it can be a more reliable medicine. Regular psilocybin can produce a greater variation between individuals, meaning that the effects of the medicine may be different across different people, depending on biological variables.
And finally, the fact that lower doses of CYB003 can be administered than regular psilocybin to produce the same effect, means the medicine may be somewhat safer. While psilocybin itself is already extremely safe, there can be some negative health consequences, such as increasing cardiovascular risks.
Speaking of safety, Cybin found that CYB003 had a “safe and well-tolerated therapeutic profile,” and no patients underwent a serious adverse event.
Therefore, Phase 1 of their Phase 1/2a trial seems like it was a roaring success — though of course, we will need to see follow-up trials confirming everything found in this trial.
All of this will mean nothing, however, if CYB003 is not found to be an effective medicine in the Phase 2a portion of the trial, attempting to treat Major Depressive Disorder. At the end of the day, all of the above benefits only matter if CYB003 is as effective in treating mental health conditions as regular psilocybin, despite its shorter duration of effect.
While we do not have any data yet on the effectiveness of CYB003 in treating Major Depressive Disorder, Cybin did report that 57% of participants “reported their experience was either the most or among the top 5 most meaningful experiences of their lives.” Furthermore, “57% of participants reported the CYB003 experience was either the most or among the top 5 psychologically most insightful experiences of their lives.”
While this data is not necessarily out of the norm for psychedelic experiences, it does bode well for CYB003 being as effective in treating mental health issues as traditional psilocybin. Again though, we will have to see the data itself before making any definitive statements.
