This week’s news has been dominated by research-related announcements, with a number of companies enlisting universities and contract research organisations to launch novel studies.
Perhaps the most significant of such announcements was Numinus and MAPS’ news that they’re seeking approval for an MDMA-assisted psychotherapy for PTSD compassionate access trial in Canada. For this indication and treatment MAPS has completed 6 Phase 2 trials, has a Phase 3 underway, and secured a Breakthrough Therapy designation from the FDA in 2017. Bolstered by a $30m fundraise, this proposed trial is the latest milestone in MAPS’ steady progress toward FDA approval for the therapy.
In another notable update, researchers at CaaMTech successfully synthesised a psilocin analog: deprocin hydrochloride. The Company will continue to research the analog via a cooperative R&D agreement with the National Institute on Drug Abuse, which falls under the National Institutes of Health (NIH). Note that the NIH is an agency of the US Department of Health and Human Services, and is the largest biomedical research agency in the world.
We also published a new resource, which seeks to provide a visual overview of the Psychedelic Sector Landscape. Explore it today via the link below.
Psychedelic Sector News
Numinus and MAPS to Collaborate on MDMA-assisted Therapy Trial in Canada
On Wednesday we learned that Numinus and MAPS Public Benefit Corporation are set to launch a compassionate access trial of MDMA-assisted psychotherapy for PTSD.
MAPS has already completed 6 Phase 2 trials of MDMA-assisted psychotherapy for PTSD, and has a Phase 3 trial underway. This is on the basis of their Breakthrough Therapy status, awarded by the FDA in August 2017. If approved, the trial would take place at Numinus’ Vancouver clinic, with an initial group of 20 participants.
CaaMTech Synthesises Structural Analog of Psilocin
Researchers at CaaMTech have successfully synthesised and crystallographically characterised deprocin hydrochloride, 4-HO-DPT. Deprocin is a structural analog of psilocin, and is one of several such analogs synthesised by the Company via its collaboration with the Manke Lab at UMass Dartmouth.
The psilocin analog will now be studied in further detail as part of CaaMTech’s preclinical drug development program. This research will be undertaken via the National Institute on Drug Abuse’s (NIDA) Intramural Research Program (IRP), under the Company’s Cooperative R&D Agreement with the Designer Drug Research Unit (DDRU). That’s a lot to take in, but essentially the NIDA is one of the 27 Institutes that fall under the National Institutes of Health: one of the world’s foremost medical research centres and an agency of the US Department of Health and Human Services.
Field Trip Q2 Financials; Investor Update
Field Trip reported a cash position of $14m, with a net loss of just under $4m for the second fiscal quarter. Of this loss, just over half was due to general and administration expenses, while $746k was spent on R&D.
If you’re looking for a more straightforward read, Field Trip’s Operational and Investor Update is worth a look. The Company is set to expand hours at its Toronto Health Center, announcing that this week (commencing Nov 30th) is its busiest week to date at the ketamine-assisted therapy centre.
Field Trip also announced that a veteran has successfully secured reimbursement from their insurance provider for the company’s Core+ program, which includes 6 ketamine and exploration psychotherapy sessions.
Lobe Sciences Launches Preclinical Study
Lobe Sciences, formerly GreenStar, announced the launch of a preclinical study in collaboration with the University of Miami Miller School of Medicine. The company hopes to demonstrate the safety and efficacy of the combination of psilocybin and N-Acetylcysteine (NAC) via the use of rodent models. Final results from the study are expected in 2021.
Once this is proven, Lobe Sciences hopes to move forward with studies into the combination’s use in treating mild traumatic brain injury (mTBI) with PTSD.
We also received an update on Lobe’s nasal mist device, which it hopes may be used to administer the agents explained above – psilocybin and/or NAC – at preselected doses and times. The Company has engaged San Diego-based VisionWorks Engineering to begin engineering the device. We couldn’t find drug delivery devices mentioned on the Engineering company’s website, but there are a handful of medical device examples including a battery-powered centrifuge.
Nova Mentis Completes Acquisition of Pilz
NOVA has completed the acquisition of Pilz Bioscience. Pilz is seeking to develop medicinal psychedelics for neuroinflammatory conditions with high unmet therapeutic needs. The Company is initially focusing on Autism Spectrum Disorder, which they hope to ultimately treat with psilocybin-based therapies.
Entheon Contracts Research on DMT and Invests in Biotech Company ‘Wonder Scientific’
Entheon announced that it has entered into a Clinical Study Agreement with the Centre for Human Drug Research (CHDR), based in the Netherlands. CHDR is contracted by Entheon to evaluate the pharmacodynamics, pharmacokinetics and safety of DMT administered to humans via intravenous infusion.
According to CHDR’s research directory of psychiatry, the study will explore the “characterization of both [DMT’s] functional central nervous system effects and its impact on subjective experience, and to relate these to its pharmacokinetics, is crucial to properly understand DMT’s potential as pharmacotherapeutic.”
Today, the Company announced its first strategic investment, which is into biotech company Wonder Scientific Inc. Wonder is focused on developing psychedelic medicines for addiction.
Silo Pharma to Study Microdosing Psilocybin and LSD for Parkinson’s
Silo Pharma has entered into a study agreement with Maastricht University in the Netherlands for a Phase 2b study to examine the effects of microdosing psilocybin and LSD for Parkinson’s disease. Specifically, the research seeks to understand how microdosing these drugs may generate effects on the cognitive and emotional dysfunctions common in those suffering from Parkinson’s disease.
Weekend Reading
Bloomberg Video Features Psychedelics for Mental Health
In their latest Quicktake video Bloomberg covered psychedelics under the title ‘Psychedelic Drugs Are Fueling a Mental Health Revolution’. The title itself is bold, given that it’s a statement and not a question. The 12-minute video streams across popular platforms including Apple TV and Amazon, and can be accessed for free via Bloomberg’s website.
VICE Video: Can Psychedelics Make You Less Depressed?
On Tuesday, VICE also shared a 12-minute video covering the potential of psychedelics for mental health. This video provides an overview of psychedelic-assisted therapy, with comment from experts like David Nutt. Whil it’s not as rigorous as other videos, Vice holds a large audience and the video has received nearly a quarter million views already.
TheraPsil Raising Funds to Facilitate Legal Access to Psilocybin Therapy for Canadians in Medical Need
TheraPsil made headlines in August when they secured access to psilocybin-assisted therapy for four palliative Canadians. Those cases set a precedent, which has led to a whole host of similar applications for Section 56 exemptions being accepted.
Last month, TheraPsil surprised many with the news that they had secured Canada’s first non-palliative Section 56 exemption, allowing Mona Streleaff to address unresolved trauma with the help of psilocybin-assisted therapy.
This is a significant milestone in allowing legal access to psilocybin, but greatly widens the patient criteria and thus the volume of individuals seeking the support of the small nonprofit. In order to grow their organisation to support such cases, TheraPsil is seeking to raise $250k via an open fundraising effort.
2 New Patent Applications by Paul Stamets
On December 3rd, two new patent applications by Paul Stamets were published. The first is the latest in a series of applications filed to cover the “Stamets Stack” microdosing composition of psilocybe and lion’s mane mushroom extracts combined with niacin.
Two of the previous applications were rejected and then appealed to the Patent Trial and Appeal Board; one rejection was affirmed last week, finding the composition ineligible for patenting as merely a natural product. This new application provides another chance to pursue other claims, including “method” claims to the use of the composition as a nootropic.
The second Stamets application published yesterday is the latest in a large family of applications covering Stamets’ work on using mushrooms for bee health and to prevent and treat colony collapse disorder. More on both applications by our editor-at-large Graham Pechenik on Twitter.
Join our Newsletter
Get the weekly bulletin plus exclusive interviews and analysis delivered to your inbox.
