Revive Begins A New Phase Of Clinical Trials
Toronto-based Revive Therapeutics is updating its development of psychedelics and clinical programs, moving towards a focus on psilocybin.
Revive is advancing a psychedelic-based product pipeline that aims to unlock the potential therapeutic value of psilocybin in various uses, formulations and delivery methods with the end goal of treating mental health, substance abuse, and neurological disorders.
Treating Psilocybin
Revive is working with the Board of Regents of the University of Wisconsin System under a clinical trial to conduct 2 phases of clinical studies to evaluate the safety and feasibility to treat methamphetamine use disorder.
- The study will be conducted at the University of Wisconsin-Madison.
- Startup activities have begun and enrollment activities are going to be continuing until 2022.
- The clinical data will provide proprietary and valuable information that will support future FDA clinical studies for oral delivery.
- Revive will have exclusive access to the key IP from the study.
Treating Traumatic Brain Injuries and Strokes
Revive is also advancing research and IP acquired from PharmaTher on psilocybin as a potential solution to managing TBI and stroke.
- Revive is proceeding to an FDA clinical study to continue researching the efficacy of psilocybin for TBI and stroke victims.
- Research in mice shows positive potential for improved cognitive function after a TBI.
Oral Delivery Development
Revive is developing a delivery method akin to a breath freshener strip. The development program is being conducted in a partnership with LTS Lohmann, a leader if oral thin films.
- The product will be a proprietary oral film strip that delivers psilocybin to the user. It is intended to be used for Revive’s research into mental illness, substance abuse and neurological disorders.
- Prototypes will soon be available and clinical studies are expected to begin in 2022.
Other Updates
- Revive is also developing a novel biosynthetic version of psilocybin based on an enzyme that will provide a potentially simple method for rapidly producing natural products.
- The company has entered into agreement to develop and clinically test new delivery systems.
Future of Psychedelics Investors Dinner
The Future of Psychedelics investors dinner took place on August 12th, and featured a presentation by leaders in the psychedelics industry and was hosted by The Huttner Group, Jade Green Consulting and Young America Capital.
- The event was reserved for accredited investors interested in learning more about the companies leading the development of psychedelic business and technology.
- The idea of the investors meeting was to bring more clarity to “the next frontier” of investment opportunities.
- A big topic of conversation for the dinner was how to emerge from the ‘failed war on drugs’
Michael Huttner, president of the Huttner Group is attempting to build an extensive network of high impact investors that are interested in the new and emerging world of psychedelics. The dinner was attended by ultra high net individuals and family offices from across the globe. Events like this indicate that psychedelics are moving more into the public eye at a rapid pace.
- Fundraising has significantly increased recently, in the back half of 2020 alone companies raised more than half a billion dollars, and the trend is continuing to rise.
The presenters included:
- AJNA Biosciences: A company focused on naturally derived compounds to help combat depression, addiction, PTSD, Alzheimers and Parkinsons disease.
- aNUma: Combining Psychedelic science with VR group experiences.
- Psychedelic Water: The world’s first commercially available, all-natural psychedelic blend that boosts the consumers mood.
Woven Science: A wellness platform that is building an ecosystem of companies in the psychedelic space.
Supplementing With Digital Therapeutics
MINDCURE Health Inc, a Vancouver company dedicated to advancing technology and research in the psychedelics space, is welcoming Dr. Ken Weingardt, CEO of Audacious Digital Health, as a consulting clinical advisor.
- Dr. Weingardt will work with the MINDCURE team to take their digital therapeutics MVP to commercial deployment.
- MINDCURE is developing iSTRYM, a digital platform that drives personalized and quantifiable outcomes to supplement psychedelic therapy. Currently the project is on schedule and budget.
- Adding Ken to the team is a hallmark moment for MINDCURE. Psychedelics are still in the early days and still fast-growing. The MINDCURE team believes that the addition of Dr. Weingardt will help them achieve better execution and inspire new levels of vision and teamwork.
Dr. Weingardt is a clinical psychologist with 20 years of experience working in behavioural heal and technology.
- He has aided companies with their fundraising efforts, achieving nearly $2B of fundraising for Woebot Health and Pear Therapeutics.
- Dr. Weingardt has worked with teams to produce FDA-approved digital therapeutics for psychiatric disorders and led development and implementation of digital technologies across the globe.
iSTRYM is a first of its kind SAAS application that optimizes the healing journey for both patients and clinicians. Bringing together evidence based treatment protocols, informed tools, integrations and patient insights.
- It will be available to a select number of clinics in Q3 2021 and will be launched broadly in 2022.
- The initial launch will target psychedelic centers and is planned to expand to integrated clinics and eventually the broader health market.
I believe Ican(nex) Get rid of anxiety
Incannex Healthcare recently submitted a proposal for a phase 2 study to help combat generalized anxiety disorder. They completed a Human Research Ethics Committee submission for their phase 2a PSI-GAD study, which will combine psilocybin with specialized therapy for patients with GAD.
- The submission includes questions to the US FDA to seek regulatory clarity for the phase 2 plans.
- Icannex is banking on the fact that Compass Pathways and Usona Institute have both made submissions for psilocybin therapy with the FDA in the past.
The Research Team
- The submissions made by Icannex were done in collaboration with a team from Monash University and led by Dr Paul Liknaitzky.
- The wider team includes international psychedelic assisted therapy and psychometric evaluation experts.
- Barring any issues, phase 2a is set to commence later this year, with phase 2b set to commence in 2022.
The Design
- The study is a triple blind, randomized, active-placebo controlled trial.
- The primary outcomes for the trial have been listed as safety, efficacy and tolerability. Secondary outcomes are quality of life, functional impairment and co-morbidities.
- The trial results will be used in planning for the larger phase 2b trial.
A Trip to… Wear?
Bexson Biomedical are working toward a wearable, psychedelic distribution device. The equivalent of a wearable insulin pump for diabetics, programmed by doctors to dose the wearer at a certain frequency and dosage.
- Bexon would like to have these units available to humans in 2022.
- Last year, the California-based organization announced that they were developing a wearable ketamine device that administers small doses of liquid ketamine. Designed for delivering pain relief to patients.
- The device was inspired by the global opioid crisis – and a desire to lower addiction rates within the US by creating a non-opioid therapy.
- The wearable is designed to “hack” the problems associated with the unpredictability of psychedelic substances. Helping increase the accuracy of dosage needed to give a particular person a particular trip.
- Everyone’s liver enzymes are different, so different doses effect different people.
The benefit of the subcutaneous device is that it allows users to fine tune their experience, and guarantee what kind of trip they are going to have. The intention is to give extremely specific treatment options for PTSD, depression and anxiety.
- Bexon is currently looking at a range of molecules and compounds that could be put to use with the wearable device.
- The key is identifying which option is the best go forward for the organization.
- The company is confident that they will be able to get its ketamine therapy over the FDA line for pain therapy. Aiming for human trials in 2022 and FDA approval in 2025.
Neither the ketamine pump or the psychedelic equivalents have been tested on human subjects as of yet.
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