The application is for a clinical trial that intends to test the psilocybin extract for bioavailability and tolerability on 20 healthy volunteers.

Numinus Wellness has submitted an application to Health Canada for its Phase I study, HOPE, on its naturally derived psilocybe extract formulation, NBIO-01.

HOPE is a two-phase study that will take place at a Numinus’ clinic in Vancouver. The company intends to begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers, if approved.

Science officer and general manager at its Health Canada-licensed research facility, Numinus Bioscience, Sharan Sidhu, commented: “This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies.

“The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development. 

“This natural product has been developed to be shelf stable, minimally variable and consistently meet label claims. The trial will not only assess safety but also give us data on comparative bioavailability.”

“At Numinus, we are focused on developing products and services in-house to ensure that high-quality standards are maintained,” added Payton Nyquvest, founder and CEO.

”I am very proud of the Numinus team – from our Bioscience experts who developed the product, to our clinical research team who will administer the study. 

“We look forward to achieving more milestones in our mission to make psychedelic-assisted therapies accessible to all who wish to safely use them.”

NBIO-01 is Numinus Bioscience’s first proprietary formulation developed from extracts generated using patent-pending technology. 

A patent was earlier submitted to the US Patent and Trade Office and announced on June 24, 2021. The formulation has been developed to stably deliver psilocybin and other synergistic compounds.

The world’s first controlled study exploring the use of ketamine-assisted psychotherapy for the treatment of alcohol use disorder (AUD) has shown positive results.

Results from the Awakn Life Sciences’ Phase IIa/b study investigating ketamine-assisted therapy for the treatment of AUD has shown 86 per cent abstinence for six months following treatment. The therapy has the potential to save lives, according to the study’s lead researcher.

The primary and secondary endpoints of the double-blind placebo-controlled clinical trial, which included 96 patients with severe AUD, were days abstinent and relapse at six-month follow-up.

Results from the study have been published in the American Journal of Psychiatry.

“Alcohol Use Disorder is pervasive and persistent public health issue, affecting at least 390 million people globally. Treatment rates are low and relapse rates post-treatment tend to be high. We urgently need new and more effective treatments,” said psychopharmacology professor Celia Morgan, who led the trial conducted by the University of Exeter.

The findings demonstrated that ketamine combined with proprietary manualised therapy (KARE) therapy, resulted in total abstinence in 162 of 180 days in the following six-month period. This was an increase in abstinence from around 2 per cent prior to the trial to 86 per cent post-trial.

The results for relapse at six months showed that the Ketamine plus KARE group’s risk of relapse was 2.67 times less than the placebo plus alcohol education group.

Morgan, who is also Awakn’s head of ketamine-assisted therapy for addiction, added: “We found that controlled, low doses of ketamine combined with manualised psychological therapy can significantly increase post-treatment abstinence rates.

“This is extremely encouraging, as we normally see three out of four people returning to heavy drinking within six months of treatment. With the data we’ve collected from this study, along with emerging data from other studies of ketamine to treat AUD, they strongly suggest that further trials of this treatment are warranted.”

Participants in the trial were randomised into four groups. The first, three ketamine infusions plus KARE; the second, three saline infusions plus KARE; the third, three ketamine infusions plus alcohol education; and the fourth, three saline infusions plus alcohol education.

The secondary outcomes of the study also identified encouraging results including improved liver function across several different markers, a statistically significant decrease in depression after three months and a decrease in anhedonia, which is the inability to experience pleasure.

Morgan identified further significant results in the reduction in heavy drinking days.

At six months post-trial, there were only 12 heavy drinking days in the ketamine plus KARE group – a steep reduction compared to other trials in this area. For example, a US study of detoxified alcoholics in outpatient alcohol treatment reported 52 heavy drinking days at the same six-month marker and it is widely believed the real-world data is far higher than this.

There was also a 10-fold decrease in the risk of mortality; one in eight patients would have died within 12 months without treatment, a number which decreased to one in 80 following the treatment.

In total, the trial demonstrated that three subanaesthetic infusions of ketamine support abstinence from alcohol and that abstinence may be further enhanced when ketamine treatment is combined with therapy.

Anthony Tennyson, Awakn’s chief executive, commented: “We are so pleased to see such encouraging results in an area of treatment that has been stagnant for so long, leaving so many people with little or sub-par options available to them.

“We will continue to support this research and future clinical trials as we push to bring a radical shift in the alcohol addiction treatment industry.”

Awakn has acquired the intellectual property to the therapy under license for use in further research, its clinics in Europe, and its partnerships globally.

A new collaboration is aiming to develop psychedelic medicines to address the unique needs of people living with a variety of mental health conditions.

The partnership to develop the psychedelic medicines is between the McQuade Center for Strategic Research and Development (MSRD) and Mindset Pharma.

MSRD has made a $5m (£3.69m) investment to support the discovery and development of novel chemical entity assets of Mindset Pharma. It will support the development of two families of Mindset’s novel psychedelic compounds through Phase Ia and Phase IIb clinical trials.

“Exploring multiple paths is essential as we work to address the unique needs of individuals living with mental health conditions,” said Robert McQuade, Ph.D., president of MSRD, a member of the global Otsuka family of pharmaceutical companies.

“We look forward to collaborating with Mindset on these assets and are hopeful that medical psychedelics could be approved to treat mental illness in the future,” added McQuade who is also chief strategic officer at Otsuka.

James Lanthier, chief executive officer of Mindset, added: “It is our great pleasure to collaborate with MSRD, a member company of Otsuka, to further the development of two of our families of novel psychedelic compounds. 

“We look forward to leveraging their extensive experience in drug development and CNS indications to accelerate and de-risk our development pathway as we prepare to launch clinical trials.

“There is a high unmet need for innovative treatments of mental illness. This collaboration further validates our belief that optimised and patentable next-generation psychedelic compounds will be the future of treatments for mental illness.”

“This transformational transaction is a validation of what our team has accomplished over the last several years,” said Richard Patricio, chairman of Mindset’s board. 

“We are ecstatic that Otsuka has chosen to collaborate with Mindset in the novel psychedelic drug development space and see this as a pivotal moment in Mindset’s maturation. 

“Our team is excited to work closely with MSRD to help meet the unmet needs of millions of people worldwide suffering with a variety of mental disorders. The future is truly exciting.”

MSRD and Mindset may agree to expand the collaboration to continue to develop the compounds as pharmaceutical products.