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NEW YORK, June 15, 2022 /PRNewswire/ — Elon Musk believes that psychedelics and other plant-based drugs are better than pharma meds in treating a number of mental health conditions. The Tesla CEO said in a tweet last month that he had interacted with many people who have been helped by ketamine and psychedelics more than amphetamines and SSRIs. A few days ago, Musk tweeted that psychedelics and MDMA should be seriously considered for therapeutics as they can make a real difference in mental health, especially for extreme depression and PTSD. This message was a response to a tweet by Doug Drysdale, the CEO of Cybin Inc. CYBN CYBN, who said the pharmacoeconomic potential of these substances could massively reduce the $2.5 trillion cost of mental health. Legal psychedelic drugs are expected to disrupt the multi-billion dollar mental health field as more clinical trials are conducted that focus on the use of substances such as MDMA, ketamine, and psilocybin in conjunction with therapy for conditions such as depression, anxiety and severe PTSD. Cybin Inc., as well as other psychedelic-focused companies like Mind Medicine (MindMed) Inc MNMD MMED, Compass Pathways CMPS, Seelos Therapeutics SEEL and Numinus Wellness NUMI NUMIF have several ongoing studies regarding the use of psychedelic drugs as alternative treatment options.
Cybin Inc. CYBN CYBN creates safe and effective therapeutics that address mental health issues. The biopharmaceutical company is a multi-program clinical-stage company with four sponsored human trials underway in 2022.
On June 9, Cybin Inc. announced that it had received Institutional Review Board (IRB) approval to commence the first-in-man Phase 1/2a clinical trial evaluating CYB003, its proprietary deuterated psilocybin analog, for the treatment of major depressive disorder (MDD).
Cybin CEO Doug Drysdale said, “IRB approval of our trial protocol is a significant regulatory milestone for CYB003 as it leads us one step closer to potentially providing this important treatment option to people in need. The team has worked tirelessly to move this program into the clinic, and we look forward to initiating the study in mid-2022 and further supporting our mission to develop psychedelics into therapeutics.”
In May 2022, Cybin announced that it had submitted an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for its Phase 1/2a first-in-human clinical trial evaluating CYB003. Cybin has hired Clinilabs Drug Development Corporation to carry out the Phase 1/2a clinical trial. Clinilabs is a global full-service contract research organization with deep expertise in central nervous system drug development.
On June 7, Cybin announced that it has entered into an agreement to acquire a Phase 1 study of N,N-dimethyltryptamine (DMT) from Entheon Biomedical Corp. to accelerate the clinical development of CYB004, Cybin‘s proprietary deuterated DMT molecule for the potential treatment of anxiety disorders. The purchase price for the acquisition is C$1 million. Up to an additional C$480,000 is payable for consulting services to be provided by Entheon up to twelve months after the closing of the acquisition.
The CYB-004-E Phase 1 study (formerly named EBRX-101), is being conducted in the Netherlands at the Center for Human Drug Research, a leading independent foundation specializing in innovative clinical drug research. With 50 healthy volunteers who smoke tobacco, this is the largest Phase 1 DMT clinical study conducted to date. Pending the closing of the acquisition, the CYB004-E study is expected to provide critical safety and dosing optimization data and will replace Cybin‘s planned pilot study for CYB004 which was scheduled to begin in the third quarter of 2022. Entheon will continue to support the CYB004-E study and act as an external consultant to Cybin.
For more information about Cybin Inc CYBN CYBN, click here.
Other Companies Are Developing Innovative Treatments for Mental Health Issues
Mind Medicine (MindMed) Inc MNMD MMED has announced 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, a Phase 2 investigator-initiated clinical trial of LSD in the treatment of anxiety disorders, at the London’s PSYCH Symposium on May 11, 2022. The presentation, titled “LSD as a Treatment for Anxiety Disorders: New Evidence of Efficacy”, will present important preliminary safety and efficacy results of lysergic acid diethylamide (LSD) in 46 patients dealing with clinically significant anxiety.
On May 3, Compass Pathways CMPS announced that positive data demonstrating the potential of COMP360 psilocybin therapy in treatment-resistant anorexia nervosa and severe depression were presented at the Society of Biological Psychiatry Annual Meeting in New Orleans, from two investigator-initiated studies. Compass recently partnered with One Mind, a leading California-based mental health research nonprofit, to sponsor three “2022 One Mind – COMPASS Rising Stars 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. The three winners, which will be announced in September, will each receive a Compass-sponsored $300,000 research grant over three years.
On June 9, clinical-stage biopharmaceutical company Seelos Therapeutics SEEL announced data demonstrating statistically significant down regulation of mRNA and reduction of alpha synuclein in an in-vitro gene therapy study of SLS-004, the company’s gene therapy program utilizing CRISPR-dCas9, in dementia with Lewy bodies (DLB). The goal of Seelos‘ study was to extend the existing SNCA-targeted epigenome therapy system (SLS-004) by modifying the viral vector to target specific cholinergic neurons in the cortex afflicted in DLB and validate the efficacy in human-induced pluripotent stem cells (hiPSC) derived neuronal systems. The company plans to advance the study of SLS-004 in DLB in additional preclinical studies and disclose further developments of this new CRISPR-based therapeutic technology in the future.
On April 14, Numinus Wellness NUMI NUMIF announced its quarterly results for the three and six months ended February 28, 2022. Revenue increased 240% year-over-year to $0.8 million in Q2 2022, primarily due to the Mindspace and Toronto Neurology Center acquisitions. The loss was $7.8 million in the quarter, compared to a loss of $4.2 million in the prior-year quarter. Numinus had a cash balance of $48.3 million as of February 28, 2022. On April 29, Numinus launched Music As Medicine by Numinus, a series of ceremonial concerts exploring the role music plays in psychedelic-assisted therapy and mental health. Following the recent announcement of Numinus‘ expansion plans to the United States, Music As Medicine by Numinus will be hosted in various cities across the United States and Canada, celebrating the company’s arrival in the United States and strengthening its community in Canada.
In a partnership with tech company Kernel, Cybin is leveraging Kernel’s Flow to quantify brain activity during real-time psychedelic experiences. Kernel Flow® is a non-invasive brain interface that records cortical hemodynamics in real-time to establish accurate patterns of brain activity. Cybin and Kernel recently announced pilot results from an ongoing feasibility study currently underway that demonstrated changes in functional brain connectivity during a psychedelic experience.
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