Voters in Colorado will have a say in the legalization of psychedelic drugs this November as an initiative to legalize psilocybin mushrooms and other naturally occurring psychedelics appears on the general election ballot. Known as the Natural Medicine Health Act (NMHA), the proposal would legalize the cultivation, manufacturing, testing, transportation, sale and purchase of psilocybin and psilocin, the psychoactive compounds in ‘magic mushrooms,’ and other natural psychedelic drugs. If voters approve the NMHA in the November general election, the psychedelic drugs legalized by the measure would only be available from licensed “healing centers,” which would be regulated by the state. Unlike a similar ordinance passed by Oregon voters in 2020, local governments would not have the power to ban healing centers from their jurisdictions. The legalization of psychedelics in Colorado would be a great development for companies delivering or researching psychedelics treatments, such as Numinus Wellness Inc. (TSX:NUMI) (OTCQX:NUMIF), Atai Life Sciences N.V. (NASDAQ:ATAI), Seelos Therapeutics (NASDAQ:SEEL), Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED), and Cybn Inc (NEO:CYBN) (NYSEAMERICAN:CYBN).
Numinus Wellness Inc. (TSX:NUMI) (OTCQX:NUMIF), a mental health care organization developing innovative treatments and evidence-based psychedelic-assisted therapy, has continued to advance its research.
On October 5, the company announced that its research division, Numinus Bioscience, has developed a psilocybin-containing tea bag for use in clinical research and eventual treatment of clients in psychedelic-assisted therapy if the appropriate regulatory approvals are granted.
The Psilocybe tea bag, which was designed to deliver 25 mg per dose of Numinus’ validated psilocybe cubensis strain, will be studied in a Phase 1 trial with the goal to be used in Numinus’ research, including trial partnerships at the company’s clinical trial management division, Cedar Clinical Research. The product has also been submitted to Health Canada to be included on the psilocybin supplier list for the federal Special Access Program (SAP), which allows health care providers to provide psychedelic-assisted therapies to patients with demonstrable need.
“Numinus recognizes that solid therapeutic products, such as whole mushrooms or pills, might be unappealing or difficult to use by certain populations, such as some people receiving palliative care for serious illnesses,” said Numinus Chief Science Officer Dr. Paul Thielking. “This new product is part of our commitment to increasing accessibility to psychedelic-assisted therapies for those in need, while contributing to the growing research that suggests psilocybin use in combination with therapy may be highly effective for treating mental health disorders.”
Numinus has also continued to enhance its brick and mortar clinic business. On September 22, the company announced the establishment of a new facility in Montreal, Canada, to replace an existing downtown clinic. The new location in the Plateau neighbourhood will have more capacity to provide ketamine treatments, including a broader range of ketamine-assisted therapy choices.
“There is significant research showing ketamine can be highly effective in treating depression, addiction, trauma and anxiety, and other common mental health disorders,” said Jason Lapensee, Numinus SVP, Clinical Operations. “Numinus is taking this evidence into consideration as we continue to expand our clinic network and treatment programs across North America.”
Numinus remains committed to the safe and evidence-based use of ketamine in conjunction with traditional therapy. Enhanced services will include ketamine delivery methods such as Spravato, intramuscular, lozenge, and nasal spray, as well as treatment length and session type options.
Numinus currently operates 13 clinics in Canada and the United States, including locations in British Columbia, Ontario, Quebec, Arizona, and Utah, offering comprehensive services ranging from mental health therapy to neurologic care.
On September 19, Numinus announced that its Toronto clinic, the Neurology Centre of Toronto (NCT) by Numinus, is now delivering ketamine-assisted therapy to patients suffering from neurological diseases.
NCT specializes in illnesses such as epilepsy, concussion, brain injury, and functional neurological disorders, providing a broad spectrum of services such as basic neurologic care and supportive therapies provided by a team of more than 20 specialists. The new programme will be overseen by a psychologist and will adhere to Numinus’ existing protocol for ketamine-assisted treatment, which is already in use at its other locations in Canada and the United States and includes sessions for medical screening, medication administration, and integration therapy. The approach will be tweaked to make it more appropriate for people suffering from neurologic disorders. Following the evaluation of the initial cohort, a group of existing patients were considered as candidates, with plans to treat further patients.
Healthcare Companies Advance Experimental Psychedelic Therapies
Atai Life Sciences N.V. (NASDAQ:ATAI) announced that it has signed a term loan agreement with Hercules Capital, Inc. for a maximum loan amount of $175 million. According to the terms of the loan, $15 million was taken at closure. Following that, another $20 million was made available to Atai by March 15, 2023, and another $25 million was made available to Atai by December 15, 2023. The remaining $115 million becomes available in tranches through March 31, 2025, subject to a few requirements being met. In the second quarter, research and development costs were $17.9 million and $33.4 million, respectively, compared to $16.0 million and $21.6 million in the same prior year periods. Atai reported a net loss attributable to shareholders of $36.6 million, which includes $9.5 million in non-cash share-based compensation expenses. This is a decrease from the comparable prior year period’s net loss of $48.5 million, which included $37.5 million in non-cash share-based compensation expenses.
According to an announcement made by Seelos Therapeutics (NASDAQ:SEEL) on September 13, Acadia Healthcare Company, Inc. will participate in the registration-directed Proof of Concept study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder. Part 2 of Seelos‘ registration-directed study, a randomized, double-blind, placebo-controlled trial, is presently accepting participants. The aim of the study is to test the effectiveness, safety, and tolerability of repeated doses of SLS-002 (intranasal racemic ketamine) in addition to routine medical treatment on the symptoms of MDD and suicidality in individuals who are determined to be at a high risk of suicide.
Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED) revealed that the first participant in Phase 1 investigator-initiated trial has been dosed at University Hospital Basel under the direction of MindMed colleague Prof. Dr. Matthias Liechti (UHB). The purpose of the study is to compare the effects of a placebo and MDMA-like drugs, such as MDA, Lys-MDMA, and Lys-MDA, on healthy participants. The Phase 1 clinical trial is a 5-period crossover study that is randomized, placebo-controlled, and double-blinded. A total of 24 healthy participants in the trial will be given MDMA (100 mg), MDA (93.9 mg), Lys-MDMA (171.7 mg), Lys-MDA (165.6 mg), and a placebo. The primary outcome measures for this study will evaluate plasma levels of MDMA and MDA on each study day over the course of the 18-month study period as well as acute subjective effects using Visual Analog Scales (VAS) to evaluate the intensity and duration of subjective effects on a scale (0-100 percent), with higher scores representing more intense effects.
Cybin Inc. (NEO:CYBN) (NYSE AMERICAN:CYBN) announced that, ahead of schedule, it had completed all of the research and development milestones that had been necessary to create and advance its novel pipeline of experimental psychedelic therapies. In December 2020, Adelia Therapeutics Inc. signed an acquisition agreement that included these milestones. In less than two years, Cybin has gone from being a discovery-stage development firm to a clinical-stage development organisation thanks to the accomplishment of these milestones. The significant achievements were in transferring Cybin‘s psychedelic programs from the laboratory to the clinic. These significant accomplishments have helped Cybin advance its research and development pipeline, leading to the creation of clinical protocols for psychedelic substances, the discovery of potential new drug formulations and delivery strategies, and most recently, the support of the clinical-stage development of the Company’s CYB003 and CYB004 programmes for major depressive disorder and anxiety disorders, respectively.
The Numinus model, which includes psychedelic production, research, and care in clinics, is at the forefront of a change that focuses on healing instead of treating the symptoms of depression, anxiety, trauma, pain, and drug use. Numinus is at the forefront of bringing psychedelic-assisted therapies into mainstream clinical practice and laying the groundwork for a healthier society.
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