Earlier this week, we had a great conversation with CMO of psychedelic company Mydecine Innovations Group (NEO: MYCO) Dr. Rakesh Jetly to talk about his history and experience in treating veterans with PTSD. In the second part of this interview, we get more in depth on the Phase 2 Clinical Trials soon to be underway at Mydecine using psilocybin assisted psychotherapy, and the narrative Dr. Jetly wants investors to know about the future of psychedelic treatment in a host of mental disorders.
A quick recap from before: Dr. Jetly, who has over 30 years of experience working with the Canadian military, began working in clinics to treat post traumatic stress disorder in veterans in 2000, and saw little to no response to the standard evidence-based treatments available at the time. Starting around 2010, he began looking at novel approaches to treating the disorder. Be sure to see the whole episode here.
Here’s some highlights from part 2 of the interview:
COVID slowing the start of the trials
Understandably, the pandemic has delayed the beginning of human trials of psilocybin assisted psychotherapy. Jetly says that these trials must be conducted face-to-face, and they cannot begin while there is a chance of being shut down in the middle of a 16-week trial. It simply wouldn’t be fair to the patients or the practitioners involved in the research.
That’s not to say that no work is being accomplished in the meantime, however. Dr. Jetly says the pandemic has given them “time to reflect” and to consider protocols. Eight sites have been chosen to conduct the research once it begins – in the Netherlands, the UK, Canada and the United States – hopefully in Q3 or Q4 of this year.
Initial trials will be less strict on methods
Because PTSD is different than dealing with depression, the initial stage of the clinical trials will allow the investigators more flexibility in their approach. Differences might involve the dosage or in the type of therapeutic approach that accompanies the psychedelic experience – which might involve approaches such as local therapy, traditional cognitive behavioral therapy, or adaptive disclosure.
Jetly stresses that they do want a little bit of variation, but the PIs who are involved in the first clinical trial are specialized and experienced, and he wants them to able to ascertain which therapies and doses are better. The data being collected will lend itself well to meta-analysis, which will help refine later clinical trials into a more specific approach.
Psilocybin assisted psychotherapy potentially has a future of becoming a first-line treatment
Jetly says that by default, all new and novel treatments start as second-line treatments, and following scientific process is the path to making psilocybin assisted psychotherapy a mainstream option. “I don’t think we should be doing shortcuts, if we’re going to have the medical establishment … accept this approach, we’re going to do this with science, we’re going to do it with studies.”
Jetly also believes there’s potential for a vertically-integrated company like Mydecine to use the research and begin improving on nature, creating a short-duration pill format that could be taken in outpatient offices.