VANCOUVER – FlyOnWallStreet – New clinical trials based out of Australia are exploring the therapeutic benefits of psychedelics (which are currently illegal substances), in what’s been described as a “paradigm shifter” for psychiatry. In particular, it’s psilocybin, better known as “magic mushrooms” that are being dubbed as potentially “the biggest advance in treatment of depression since Prozac”. Now investors are turning towards psychedelics in droves, with new startups garnering several millions of dollars in investment in both Europe and North America, while advancements are being made by new product developers such as Pure Extracts Technologies Corp. (OTC:PRXTF) (CSE:PULL) (XFRA: A2QJAJ), atai Life Sciences N.V. (NASDAQ:ATAI), COMPASS Pathways plc (NASDAQ:CMPS), Cybin Inc. (NYSE:CYBN) (NEO:CYBN), and Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) (NEO:MMED) ahead of what the market expects to be the next big booming legal drug market. A new joint venture was recently announced between extraction experts Pure Extracts Technologies Corp. (OTC:PRXTF) (CSE:PULL) (XFRA: A2QJAJ) and partners Psyence Group Inc. (CSE:PSYG) to form a new JV company called Pure Pysence.
“Pure Psyence sits at the intersection of evidence-based science and nature,” said Ben Nikolaevsky, CEO of Pure Extracts. “The researchers, scientists and physicians at Pure Psyence will now be uniquely positioned to bring psilocybin whole mushroom in measurable pharmaceutical dosages to market; a first.”
The JV is designed for the development of nature-derived psilocybin extracts and advanced psilocybin formulations for the long-term treatment of psychological trauma and its mental health consequences.
As per the terms of the deal, Pure Psyence will leverage Psyence’s supply of in-house grown, high-quality, standardized psilocybin mushrooms with Pure Extract’s expertise in extraction technologies to produce high-quality, high-purity medicinal mushroom extracts and formulations on a commercial pharmaceutical scale.
The JV’s physicians and scientists will work to make psilocybin more accessible to leading Canadian research institutions as well as provide psilocybin to its own research team at Pure Psyence for human clinical trials.
“Psilocybin mushrooms hold a rich pharmacopeia of unique elements that Pure Psyence is researching to create breakthrough synergies in mental health solutions,” said Dr. Justin Grant, Chief Scientific Officer of Psyence.
Psyence, which is located in the Kingdom of Lesotho, and has been designed and constructed to The British Standards Institute (BSI) and Good Manufacturing Practice (GMP) standards. All their harvests are shipped with an export permit from the Lesotho Ministry of Health and a Certificate of Analysis (COA) indicating the psilocybin and psilocin potency of each batch of psychoactive mushrooms.
COMPASS Pathways plc (NASDAQ:CMPS) recently announced it had purchased an IP portfolio that includes patent applications for a variety of psychedelic and empathogenic substances. These new substances include novel derivatives of known compounds, designed to increase confidence in their respective therapeutic effects and safety profile while offering optimised characteristics.
The newly-acquired IP was developed together with inventor Matthias Grill PhD, founder and CEO of MiHKAL GmbH in Basel, Switzerland, who will be working with COMPASS on an exclusive research project to develop new product candidates.
“This agreement will strengthen and expand our IP and development portfolio with new compounds,” said Lars Wilde, Chief Business Officer, President and Co-founder, COMPASS Pathways. “We plan to move some of these compounds into clinical development within the next two years, taking us closer to our goal of helping patients with urgent unmet needs in mental health care.”
Through its subsidiary Perception Neuroscience, atai Life Sciences N.V. (NASDAQ:ATAI) recently released an update on another platform for treatment resistant depression (TRD) that’s derived from a psychedelic—in this case, ketamine, not psilocybin.
Perception announced the initiation of a Phase 2a clinical study to evaluate the safety and efficacy of its candidate, PCN-101 (R-ketamine).
"We believe insight into the molecular properties of the single isomer, R-ketamine, has the potential to offer a highly differentiated profile from current treatment options," said Florian Brand, CEO & Co-founder of atai Life Sciences. "Initiating this Phase 2 clinical study is a major step for our teams at Perception and atai and is a great achievement. We believe this work has the potential to deliver a novel option with diversified delivery capabilities that could decrease overall healthcare utilization, which may help us move toward our greater mission to improve care for patients who suffer from TRD.”
The double blind, placebo-controlled Phase 2a clinical trial has already received the necessary regulatory and ethics approvals to initiate the study. Patients will receive either placebo, a 30 mg dose, or a 60 mg dose of R-ketamine intravenously, before being assessed for depressive symptomology over the subsequent 14 days using the Montgomery-Asberg Depression Rate Scale, or MADRS.
Back in August, Cybin Inc. (NYSE:CYBN) (NEO:CYBN) filed a series of patent applications in support of its ongoing drug candidate programs, designed to bring the potential to obtain patent coverage in 153 countries for each of the patent applications.
"We continue to progress our IP portfolio across novel molecules, delivery mechanisms, processes and protocols as we continue to find new and novel discoveries through our pre-clinical findings thus expanding and strengthening IP," said Doug Drysdale, CEO of Cybin. “Cybin is dedicated to finding treatments for therapy resistant psychiatric indications as we believe these will provide patients and their medical providers with new avenues to address this significant unmet need.”
Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) (NEO:MMED) and collaborative partners UHB Liechti Lab recently updated the market with results from their multiple ongoing studies on psilocybin therapies. Novel findings in the results included comparative effects of LSD psilocybin, and psychedelics and SSRIs, which yielded the observation that psilocybin was found to be safe to administer together with an antidepressant.
"Investors and researchers alike are eager to understand the similarities between psilocybin and LSD,” said MindMed CEO Robert Barrow. “Learning how these substances compare and interact with other drugs helps us ensure that our treatment programs are as effective and efficient as possible."
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