Psychedelics could soon revolutionize mental health. After all, “Traditional medicines that are treating things like depression, addiction, and anxiety really are seeking to numb and mask the issues that surround these illnesses. So, things like Xanax, while they might make you feel better, they can also be highly addictive and are not dealing with the underlying problem,” MindMed’s co-founder and co-CEO JR Rahn told Yahoo Finance. In addition, clinical studies by New York University and Johns Hopkins are pointing to positive mental health results.
While psychedelics, like psilocybin have been in the headlines recently, another psychedelic showing progress is MDMA, the active ingredient in Ecstasy. In fact, according to research by the Multi-Disciplinary Association of Psychedelic Studies, MDMA-assisted therapy sessions help to eliminate signs of PTSD in 68% of military veteran, as reported by Radio.com. It also helped significantly reduce PTSD in 32% of the veterans. With psychedelics like MDMA showing progress, some of the top companies to watch include Numinus Wellness Inc. (TSXV:NUMI), CYBIN Inc. (NEO:CYBN), Mind Medicine Inc. (OTC:MMEDF), COMPASS Pathways (NASDAQ:CMPS), and Field Trip Health Ltd. (CSE:FTRP)(OTC:FTRPF).
Numinus Wellness Inc. (TSXV:NUMI) BREAKING NEWS: Numinus Wellness Inc., a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted psychotherapies, and the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), are pleased to announce a collaboration agreement that will seek approval to deliver MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) through a single-arm, open-label, compassionate access trial. This clinical trial will be the first-of-its-kind in Canada and will take a meaningful step in furthering the accessibility of MDMA-assisted treatment options for those experiencing PTSD around the world.
Through the completion of six Phase 2 trials and ongoing Phase 3 trials, MAPS and MAPS PBC have undertaken ground-breaking research demonstrating that MDMA-assisted psychotherapy — which recently received “breakthrough therapy” status from the U.S. Food and Drug Administration (FDA) — may provide sufficient benefit to patients experiencing PTSD to support approval from the FDA.
This compassionate access trial, if approved, will be conducted at Numinus’ Vancouver clinic, providing MDMA-assisted psychotherapy to an initial 20 individuals experiencing PTSD and collecting outcome and safety data for Health Canada. Numinus’ physicians, therapists and staff will be trained to deliver the treatment under MAPS’ clinically-tested PTSD treatment protocol prior to approval by Health Canada.
“I am delighted to announce this collaboration agreement which, leveraging MAPS’ evidence-based treatment protocol and Numinus’ clinical infrastructure, will open the door to MDMA-assisted psychotherapy in Canada,” said Dr. Devon Christie, Medical Director at Numinus and a MAPS-trained therapist for the delivery of MDMA-assisted psychotherapy.
“Training Numinus therapists in the MDMA-assisted psychotherapy protocol for PTSD will provide a meaningful expansion of access to the ongoing research program for this promising treatment,” said Amy Emerson, CEO of MAPS PBC. “Though this treatment is still investigational, if approval is granted through the regulatory pathway this collaboration will bolster our shared goal of addressing the enormous — and growing — need for improved proven treatments for people suffering from PTSD.”
Dr. Rick Doblin, Founder and Executive Director of MAPS, adds, “Our commitment to open science is rooted in our mission to develop the cadre of qualified practitioners who will provide this world-class therapy. We’re excited to work with Numinus to build the case for regulatory approval through this compassionate access trial and expand best practice clinical infrastructure.”
“We are thrilled to collaborate with MAPS and deliver the meaningful framework that they have spent decades building to better support those experiencing PTSD,” said Payton Nyquvest, CEO of Numinus. “At Numinus, our mandate is to explore and expand patient access to psychedelic-assisted psychotherapies. We are proud to work alongside MAPS in furthering the regulatory landscape for psychedelic-assisted therapies, including MDMA, and setting the stage for the healthcare system of tomorrow.”
Other related developments from around the markets include:
CYBIN Inc. (NEO:CYBN), a leading Toronto-based biotech and life sciences company focused on psychedelic pharmaceutical therapies, has made its debut on the global public markets. Cybin is now trading on the NEO Exchange under the symbol NEO:CYBN. The Company recently closed a CDN$45 million subscription receipt financing in relation to its reverse takeover transaction, which marked the largest subscription receipt financing in the Canadian psychedelic sector. The Company focuses on psychedelic drug development, unique delivery mechanisms, improved novel compounds, and protocols that target psychiatric and neurological conditions.
Mind Medicine Inc. (OTC:MMEDF), a leading psychedelic medicine biotech company, is establishing a digital medicine division known as Albert. Albert is in the process of assembling and recruiting a leading team of technologists, therapists, and clinical drug development experts to help the company research, develop and build an integrated technical platform and comprehensive toolset aimed at delivering psychedelic inspired medicines and experiential therapies combined with digital therapeutics. Digital therapeutics are defined as evidence-based therapeutic interventions for patients to prevent, manage, or treat a mental disorder or disease. Pairing digital tools, such as wearables and the latest in machine learning, with psychedelic assisted therapies, can give healthcare providers the ability to optimize and better understand the patient journey and therapeutic outcomes from pre-care through to after-care.
COMPASS Pathways (NASDAQ:CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health reported its financial results for the third quarter of 2020 and gave an update on recent progress across its business. George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “This has been a significant quarter, with an IPO that gives us the funds needed to advance our mission and transform mental health care. Recent hires for the company build further important expertise within our strong leadership team, including in data science and digital health, which will be core to the future of mental health care. We remain fully focused on execution of our phase IIb trial investigating our COMP360 psilocybin therapy for treatment-resistant depression and, with scientific partners in our recently established Drug Discovery Center, are also evaluating the potential of early stage compounds to address mental health challenges.”
Field Trip Health Ltd. (CSE:FTRP)(OTC:FTRPF), a leader in the development and delivery of psychedelic therapies, reported its second fiscal quarter results for the three and six months ended September 30, 2020. For the second fiscal quarter, Field Trip reported patient services revenues of $94,532 from its Toronto and New York Field Trip Health centers, which began continuous operations in June and August, respectively. Net loss for the second fiscal quarter of $3,932,444 was primarily due to general and administration expenses of $2,182,144, research and development expenses of $745,989, sales & marketing expenses of $268,475, patient services expenses of $232,114, occupancy costs of $111,877 and realized foreign exchange loss of $196,288. Net loss for the second fiscal quarter of 2020 of $514,643 was primarily due to general and administration expenses of $411,686, occupancy costs of $59,342 and sales and marketing expenses of $43,582.
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