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New York, NY – April 28, 2022 – Oregon is set to become the first US state to market legal psilocybin, the psychoactive substance found in magic mushrooms. Authorities plan to greenlight a particular species of magic mushroom for therapeutic use in the state starting in 2023. The psychedelics sector, which started to gain steam in 2021, is showing signs of potentially strong growth according to a new report by Defiance ETFs. The report states that growth drivers such as legislative changes in favor of psychedelics, increased investment in the space, clinical trials reporting positive results, and the increased demand for psychedelic-based treatments, particularly for mental illness. Companies developing psychedelic-based treatments like Cybin Inc (NYSEAmerican:CYBN) (NEO:CYBN), Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED), Compass Pathways (NASDAQ:CMPS), Seelos Therapeutics (NASDAQ:SEEL) and Johnson & Johnson (NYSE:JNJ) could gain momentum as the market for these alternative therapies emerges.
Focused on progressing “Psychedelics to Therapeutics”, Toronto-based Cybin Inc (NYSE:CYBN) (NEO:CYBN) has been hyper-focused on advancing clinical trials. The biopharmaceutical company is studying derivatives of psilocybin and DMT to develop the next generation of psychedelics to potentially treat major depressive disorder (MDD), alcohol use disorder (AUD) and anxiety.
On April 21, Cybin announced a partnership with Clinilabs Drug Development Corporation to complete the Phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analog. Clinilabs has deep expertise in central nervous system drug development. CYB003 will be the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of MDD.
“We are delighted to partner with the Clinilabs team as we progress this important program toward a first-in-human Phase 1/2a trial. Clinilabs brings a unique combination of scientific and operational experience and deep expertise in clinical research across a range of psychiatric, neurological and substance use disorders,” said Cybin’s CEO Doug Drysdale. “Clinilabs is ideally suited to help us accelerate the regulatory pathway for this promising treatment candidate and ultimately, to effectively treat those suffering with MDD.”
CYB003 demonstrated significant advantages over conventional psilocybin in multi-species preclinical studies. Cybin plans to submit an IND to the FDA in the second quarter of 2022 and to start the Phase 1/2a trial in mid-2022.
Earlier in April, Cybin announced positive preclinical data from a pharmacokinetic study evaluating its proprietary deuterated dimethyltryptamine (DMT) molecule, CYB004, administered by inhalation. Inhaled CYB004 demonstrated significant advantages over intravenous and inhaled DMT, such as improved bioavailability and longer duration of action. Cybin is currently developing CYB004 for the treatment of anxiety disorders.
The company plans to file a regulatory filing for a pilot study in the second quarter of 2022 and to start the pilot study in the third quarter of the same year.
For more information about Cybin Inc (NYSE:CYBN) (NEO:CYBN), click here.
Biopharma Companies Are Advancing Studies on Psychedelics
Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED), a clinical-stage biopharmaceutical company developing new products to treat brain health disorders, announced on April 14 that Dr. Friederike Holze and Prof. Dr. Matthias Liechti, MindMed collaborators at University Hospital Basel (UHB), will present the results of the LSD-Assist study, an investigator-initiated Phase 2 clinical trial of LSD in the treatment of anxiety disorders, at the PSYCH Symposium in London on May 11, 2022. The presentation will present key preliminary safety and efficacy results of LSD in 46 patients with clinically significant anxiety. MindMed recently appointed François Lilienthal, MD, as Chief Commercial Officer. With more than 20 years of global biopharmaceutical experience and having served as a consultant to MindMed for the past six months, Dr. Lilienthal will assume this role to support the advancement of the company’s clinical development programs.
Compass Pathways (NASDAQ:CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, just announced a partnership with One Mind, a nonprofit research organization in leading California-based mental health, to sponsor three “2022 One Mind – COMPASS Rising Star Awards”. The One Mind Rising Star Awards are given annually to promising early career researchers who are pursuing research that has the potential to significantly advance the understanding and treatment of mental illness and improve patient outcomes. Up to three winners will be announced in September 2022 and will receive a Compass-sponsored $300,000 research grant over three years.
Johnson & Johnson (NYSE:JNJ) paved the way for psychedelic medicine’s mainstream approval with SPRAVATO®, an esketamine nasal spray taken with an oral antidepressant for adults with treatment-resistant depression and major depressive disorder (MDD) and the first FDA-approved psychedelic treatment. Last February, Johnson & Johnson announced that the European Union authorized the expanded use of SPRAVATO, co-administered with oral antidepressant therapy for adults experiencing a moderate to severe episode of MDD, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgment constitute a psychiatric emergency.
Seelos Therapeutics (NASDAQ:SEEL), a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders and rare diseases, has received an acknowledgment letter of a Clinical Trial Notification from the Australian Government Department of Health Therapeutics Goods Administration for a pilot study of SLS-005 to treat patients with Alzheimer’s disease. Seelos has also received the authorization to conduct a separate open-label basket study in Australia to assess the efficacy, safety, and tolerability of SLS-005 on disease progression and severity in participants with selected neurodegenerative diseases, including Huntington’s disease. On April 11, Seelos announced an amendment to the agreement with Phoenix AG for the development of SLS-002 (Intranasal Racemic Ketamine Program) to repurchase the remaining royalties payable on any future net sales of SLS-002 in stock and cash, all future successes, business milestones and change of control fees if SLS-002 is acquired.
Doug Drysdale, Cybin’s Chief Executive Officer, presented at the KCSA Psychedelics Virtual Investor Conference on April 28, 2022. The webcast is available on the company’s investor relations website on the Events & Presentations page.
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