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Discover first-of-its-kind collaboration to advance psychedelic therapy

Mydecine Innovations Group and Johns Hopkins University School of Medicine are collaborating to advance research into novel psychedelic therapies. 

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Discover first-of-its-kind collaboration to advance psychedelic therapy

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.

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“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.

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“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.”

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Research

Psilocybin for major depression trial launches at neuroscience institute

The trial will investigate the compound’s efficacy for major depressive disorder.

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Psilocybin for major depression trial launches at neuroscience institute

Pacific Neuroscience Institute (PNI) has initiated its psilocybin clinical trial that will investigate whether the compound can be an effective treatment for major depressive disorder (MDD).

Located at Providence Saint John’s Health Center, PNI will investigate the safety and efficacy of psilocybin for MDD, evaluating the potential antidepressant effects of a one-time dose.

PNI has begun participant enrolment for the trial. The Treatment & Research In Psychedelics (TRIP) program at Pacific Neuroscience is exploring how altered states of consciousness elicited by psychedelics can be harnessed to change behaviour and improve brain health.

TRIP programme director and addiction medicine specialist, Keith Heinzerling, MD, is the principal site investigator of the study.

Read more: Global coalition launches to push for psilocybin rescheduling

Heinzerling commented: “We are incredibly excited to be able to offer participation in this leading-edge clinical trial to people suffering with depression in Los Angeles and throughout Southern California.”

The PSIL201 Phase II, randomised, double-blinded, placebo-controlled, multi-site trial is sponsored by Usona Institute and began in 2019. Usona Institute will be providing the psilocybin for the trial as capsules.

A total of 100 participants with MDD who have no other medical conditions will be randomised to receive either a single dose of psilocybin or an active placebo.

The primary outcome measure will be change in a standardised depression rating scale (MADRS) 43 days after receiving psilocybin or placebo.

Daniel Kelly, MD, PNI director and founder, and site co-investigator of the study added: ”Given the huge demand for more effective and durable depression therapies, we are thrilled to be joining Usona Institute for this ongoing trial and are hopeful the final results will justify a larger Phase 3 Efficacy trial.”

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Review of evidence confirms ketamine reduces suicidal thoughts

A systematic review of all evidence relating to ketamine therapy has been carried out.

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Review of evidence confirms ketamine reduces suicidal thoughts

A review has shown that ketamine therapy is able to rapidly reduce symptoms of depression and suicidal thoughts in the short-term.

Led by the University of Exeter and funded by the Medical Research Council, the systematic review analysed evidence from 83 published research papers on ketamine therapy. 

It showed that the strongest evidence emerged around the use of ketamine to treat both major depression and bipolar depression, with symptoms reducing as quickly as one to four hours after a single treatment, and lasting up to two weeks. 

Single or multiple doses of ketamine resulted in moderate to large reductions in suicidal thoughts. This improvement was seen as early as four hours following ketamine treatment and lasted on average three days, and up to a week.

See also  Groundbreaking ketamine study receives approval for expansion

Additionally, some evidence suggested that repeated treatment may prolong the effects, however, the researchers involved say more high-quality research is needed to determine by how long. 

The review, which included 33 systematic reviews, 29 randomised control trials and 21 observational studies, has been published in the British Journal of Psychiatry Open.

Lead author Merve Mollaahmetoglu, of the University of Exeter, said: “Our research is the most comprehensive review of the growing body of evidence on the therapeutic effects of ketamine to date. 

“Our findings suggest that ketamine may be useful in providing rapid relief from depression and suicidal thoughts, creating a window of opportunity for further therapeutic interventions to be effective.

“It’s important to note that this review examined ketamine administration in carefully controlled clinical settings where any risks of ketamine can be safely managed.”

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For other psychiatric disorders, including anxiety disorders, post-traumatic stress disorders (PTSD) and obsessive-compulsive disorders, the review noted that there is early evidence to suggest the potential benefit of ketamine treatment, and that for individuals with substance use disorders, ketamine treatment led to short-term reductions in craving, consumption and withdrawal symptoms.

Senior author professor Celia Morgan, of the University of Exeter, said: “We’re finding that ketamine may have promising benefits for conditions that are notoriously hard to treat in clinic. 

“We now need bigger and better-designed trials to test these benefits. 

“For example, due to ketamine’s unique subjective effects participants may be able to tell whether they have been given ketamine or a saline solution as the placebo, potentially creating an expectation about the effects of the drug. 

“This effect may be better controlled by having active placebo-controlled trials, where the control group receives another drug with psychoactive properties.”

Ketamine’s therapeutic effects for psychiatric conditions other than depression and suicidal thoughts are based on small number of studies that did not randomise people into different treatment arms. The authors highlight that these effects require replication in larger randomised placebo-controlled trials, which are considered as gold standard.

A number of questions remain unanswered so far, including the optimal dose, route of administration and number of doses of ketamine treatment. 

The authors highlight that there is also a need for further research on the added and interactive benefit of psychotherapy alongside ketamine treatment.

See also  Five-year study shows single ketamine dose reduces suicidal thoughts

Additionally, the importance of ketamine’s acute subjective effects in its therapeutic benefits has not been fully explored, and more research is also needed on how to optimise participants’ preparation for ketamine treatment and the setting in which ketamine treatment is delivered.

The research involved collaboration with the University of British Columbia, and received support from the Society for the Study of Addiction.

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Groundbreaking ketamine study receives approval for expansion

A study exploring the use of ketamine to treat gambling addiction will be expanded to include three additional addiction disorders.

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Groundbreaking ketamine study receives approval for expansion

The groundbreaking study will now be expanded to explore the use of ketamine for treating binge eating disorder, compulsive sexual behaviour and internet gaming disorder.

Awakn Life Sciences is carrying out the world’s first study exploring the use of ketamine-assisted psychedelic therapy to treat gambling addiction. The study has now received ethical committee approval to include an additional three addictive disorders.

There are currently no licensed pharmacological treatments for behavioural addictions or disorders available, meaning there is a vital need to find new and effective treatment options.

The basket study is led by professor Celia Morgan, Awakn’s head of ketamine-assisted therapy for addiction, professor of psychopharmacology at the University of Exeter, and an internationally respected expert in the therapeutic use of ketamine.

See also  Awakn initiates first ever ketamine treatment study for gambling addiction

Morgan commented: “We are delighted to expand this research and to make further inroads into a treatment area that has had no material pharmacological advancements in far too long, all the while the number of people suffering has steadily increased.

“We hope this will give us valuable insights to push our ketamine programme forward and help these people as quickly as possible.”

Morgan’s work will investigate a new treatment approach for these behavioural addictions, trying to harness a window in which the brain is able to make new connections. The study will explore and monitor whether ketamine can increase neuroplasticity using electroencephalogram (EEG).

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The global populations affected by behavioural addictions are huge – with binge eating disorder affecting up to 110 million people; internet gaming disorder affecting 238 million; sexual compulsive behaviour affecting up to 350 million; and gambling disorder up to 450 million people.

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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