Mydecine Innovations Group recently signed a five-year agreement with Johns Hopkins University School of Medicine that will advance research on novel psychedelic therapy. Psychedelic Health spoke with Mydecine’s CEO, Josh Bartch, to find out what the organisations are aiming to accomplish through the collaboration.
Biotechnology company, Mydecine, focused on first and second-generation novel therapeutics for mental health and addiction, has entered into a collaboration with the Johns Hopkins University School of Medicine that will focus on smoking cessation and PTSD.
The collaborative research will be led by Dr Matthew Johnson, PhD, a professor of psychiatry and behavioural sciences at Johns Hopkins University School of Medicine, who has extensive experience conducting clinical research on therapeutic psychedelics.
“We started the dialogue with Dr Johnson and we were intrigued by some of the work that he was doing specifically around smoking secession,” Bartch commented, highlighting that cigarette smoking is the leading cause of preventable death in the US, killing more than 480,000 people each year.
“The first part of the research collaboration is specifically for smoking secession and the clinical trial that we are conducting, which is based off the prior trials and current ongoing trials that Dr Johnson has conducted. This looked at utilising psilocybin in combination with cognitive behavioural therapy for treatment-resistant smokers.”
The smoking cessation pilot study carried out by Johnson looked at a patient population of 15, who had unsuccessfully tried to quit over five times. The findings showed that, after three macrodose treatments of psilocybin coupled with CBT, 80 per cent of the participants were completely abstinent from smoking at six months. Furthermore, 67 per cent were completely abstinent from smoking at 12 months.
“What we are offering is a solution to the overall addiction – fixing the fundamental addiction, which is something that is incredibly exciting not only for smoking cessation as an indication but more broadly for addiction. So, we started to really dive into the continuation study that is currently underway out of Hopkins that is looking at a larger patient population of 80 patients.
“For this study, the researchers used a single macrodose of psilocybin, instead of three, coupled with CBT and compared this to the gold standard of a nicotine patch and the identical use of CBT protocols.”
Mydecine has been collaborating over the last several months with the Weinberg Group which is an internationally recognised FDA consultancy, and the Hopkins team to design a Phase II/III smoking cessation clinical trial utilising Mydecine’s MYCO-001 product.
MYCO-001 will be supplied for this multi-site study which is led by Dr Johnson and which is being carried out at Johns Hopkins University, New York University and the University of Alabama Birmingham. For this, Johnson received a grant from the National Institute on Drug Abuse (NIDA), which was the first US Government grant in over 50 years for a psychedelic study.
“Additionally, we are also collaborating with the Hopkins team to develop the best-in-class and gold standard of cognitive behavioural therapy (CBT) training manuals for addiction and PTSD. This is something that we are very excited about.”
Mydecine has further compounds it will be working with including MYCO-004, the company’s lead novel candidate which will also be explored for smoking cessation and substance use disorder. It has been developed to be fully skin permeable and delivered on a patch.
“What we have done with MYCO-004 is iteratively gone through and made conservative changes to the molecule to address known limitations to the first generation, looking at controlling things such as half-life, uptake time, and stability, and making layers of stackable features that are all individually patent protected.
“We took a psilocin analogue that is owned and proprietary to Mydecine. From a binding affinity perspective, it binds very similarly to a psilocybin or psilocin analogue, so, we firmly believe that the potential outcomes will be almost identical to the first generation of drugs, but it carries a two-hour half-life with increased stability.
“We have also been able to change the lipophilic properties of not only psilocybin and psilocin but several other tryptamine categories that allow them to be fully skin permeable, and we are doing a lot of biomarker tracking that we think is really going to prove the underlying mechanistic change that’s happening. This could help get the acceptance from the medical community.”
Bartch says Mydecine aims to take MYCO-001 through for FDA approval in conjunction with Hopkins and receive one Breakthrough Therapy status in the short term to bring the medicine to patients.
“We look forward to collaborating further with them in the future to better the first generation of treatments and really continue to improve in order to bring the best possible medicine forward for patients that need it. Hopkins has an incredible voice and it is an honour to be pairing with them, and, as we already have a very strong global infrastructure, we will be expanding outside the US.”
