Chief Commercial Officer, Graeme McFarlane, discusses the Imperial College study on the effects of psilocybin on severe depression and explains how the need for pragmatic research highlighted in the study, favours Albert Labs’ Real-World Evidence clinical trials.
Read the full transcript with Proactive London below:
So today we’re discussing a recent study on psilocybin and this is the compound that’s found in Albert Labs’ KRN-101 medicine and over 200 mushroom species, as well. It’s created somewhat of a media buzz this week. The study draws attention to psilocybin’s ability to not just alleviate symptoms of depression but lead to a sustained improvement over the weeks following. So Graeme, how are Albert Labs using psilocybin and how does the report support Albert Labs investigation of psilocybin-assisted psychotherapy?
You’re aware from our previous discussions that Albert Labs is using unique cultivation and extraction processes to produce consistent naturally occurring psilocybin for the treatment of cancer-related, depression, and anxiety. An area you’ll recall of high unmet need.
Our overarching aim is to bring our innovative treatments, KRN-101, to market together with providing robust clinical evidence in support of informed treatment for this patient cohort. This excellent paper from Imperial College, not only provides insight for the first time in to the actual mechanism of action of psilocybin in the brain in relation to effectively treating depression. Resetting the psychological dial, but also signposts the need for pragmatic or as we call it Real-World Evidence (RWE) studies to build on their findings and then examine how psilocybin assisted psychotherapy works on the day-to-day treatment setting. Exactly the direction that Albert Labs is going in.
And Graeme, there’s a mention of the need for pragmatic trials for licensing of psilocybin therapy. What was meant by a pragmatic trial approach to clinical trials.
It’s an interesting terminology. Our day-to-day language in Albert Labs, and for many others is the Real-World Evidence study we discussed, but pragmatic trials are designed to evaluate the effectiveness of interventions and real life routine practice conditions. Whereas explanatory trials, such as RCTs that’s random controlled trials, aim to test whether an intervention works under optimal conditions. Pragmatic trials go step further in producing results that can be generalized and applied into routine practice settings.
It’s a great piece, there’s a great trial and it’s a great ambition, but it also supports Albert Labs’ goal of generating well-controlled, data-driven Real-World Evidence studies to illustrate the effectiveness of our KRN-101 psilocybin treatment with the psychological support you mentioned.
This allows us to bring out proprietary psilocybin to market quickly and to achieve our overall aim, to provide early access for patients in real need of an innovative and effective alternative. And that’s what it means to us.
Really interesting. Thank you very much for offering us your expertise this morning. That’s Graeme McFarlane, the Chief Commercial Officer of Albert Labs.
Read the original study here.
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