NeonMind Biosciences (CSE:NEON)(OTC:NMDBF) is a step closer to bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders. With obesity, for example, worldwide obesity has tripled since 1975, says the World Health Organization. Plus, as of 2016, more than 1.9 billion adults were considered overweight, with 650 million considered obese. The good news is psilocybin may be able to help. That’s because psilocybin activates serotonin receptors, or “nature’s own appetite suppressant,” as noted by Psychology Today. “This powerful brain chemical curbs cravings and shuts off appetite. It makes you feel satisfied even if your stomach is not full. The result is eating less and losing weight.” That could be game-changing news for NeonMind Biosciences (CSE:NEON)(OTCQB:NMDBF), and other companies researching the benefits of psychedelics including COMPASS Pathways (NASDAQ:CMPS), Cybin Inc. (NEO:CYBN)(NYSE:CYBN), Field Trip Health Ltd. (TSX:FTRP)(NASDAQ:FTRP), and Mind Medicine Inc. (NASDAQ:MNMD)(NEO:MMED).
With regards to mental health, it’s on the decline all over the world. In the U.S. for example, the White House noted, “Our country faces an unprecedented mental health crisis among people of all ages. Two out of five adults report symptoms of anxiety or depression. And, Black and Brown communities are disproportionately undertreated – even as their burden of mental illness has continued to rise. Even before the pandemic, rates of depression and anxiety were inching higher. But the grief, trauma, and physical isolation of the last two years have driven Americans to a breaking point.” In Canada, for example, more Canadians are struggling with mental health issues, especially with the pandemic.
NeonMind Reports Business Highlights on Partnership Activities, Clinical Pipeline and Corporate Developments
NeonMind Biosciences, an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, today provided a summary of business highlights on the Company’s activities and progress across its Pharmaceutical and Medical Services Divisions.
Pharmaceutical Division Highlights
– Successfully completed a pre-Investigational New Drug (pre-IND) consultation with the U.S. Food and Drug Administration (FDA) regarding proposed clinical trials for NeonMind’s lead obesity drug candidate, NEO-001. The Company expects to file its IND application in the first half of 2022 and initiate a Phase 1/2 clinical study during the course of this year.
– Filed four new provisional patent applications with the United States Patent and Trademark Office to protect NeonMind’s proprietary data derived from the Company’s initial preclinical trial examining the potential use of psilocybin as a treatment for weight loss.
– Completed an integrated drug development plan for its lead drug candidate targeting obesity, NEO-001, a high-dose psilocybin treatment coupled with behavioral therapy and lifestyle intervention, aimed to improve the efficacy of chronic weight management in adults.
– Established a Research and Development Advisory Board and expanded NeonMind’s team with regulatory experts to successfully execute its integrated drug development plan and streamline its corporate structure for capital efficiencies.
– Appointed drug development executive Philippe Martin as Chairman of the Company’s Research and Development Advisory Board.
Medical Services Division Highlights
– Established strategic alliances with SRx Health Solutions and BioScript Solutions, leading Canadian specialty healthcare services and medical treatment providers, to establish and operate a network of NeonMind specialty clinics to deliver evidence-backed innovative treatments for a variety of mental health needs.
– Announced inaugural specialty mental health clinic location in Mississauga, Ontario; expected to begin treatment services in the second half of 2022.
– Appointed emergency and addiction expert, Dr. Dinesh Bhayana, as site medical director of its inaugural specialty mental health clinic.
– Formed a Specialty Clinics Advisory Board with Canadian medical leaders in mental health and to guide planning and operation of NeonMind clinics, protocols and treatment models across Canada.
“We made significant progress in our corporate transformation to become a psychedelic drug developer and specialty mental health clinics operator,” said Robert Tessarolo, President & CEO of NeonMind. “Our strategic focus provides near-term revenue generation and a proprietary groundbreaking treatment for obesity, both of which provide exposure to exciting and novel treatments for mental health and wellness. We now have a clear drug development pathway to bring NEO-001, the first and only psychedelic-based treatment for obesity, into clinical trials. Additionally, our strategic alliances with SRx and BioScript will enable us to quickly establish a network of NeonMind-branded specialty mental health clinics across Canada. As the psychedelic industry continues to undergo rapid expansion, we are well positioned to execute on our growth strategy and develop innovative therapeutic uses for psychedelic compounds to treat weight management conditions and mental health disorders.”
– The Company’s common shares, listed on the OTCQB Venture Market, became eligible for electronic clearing and settlement through the Depository Trust Company (“DTC”) in the United States.
– Completed divestiture of assets related to its consumer division, including e-commerce operations and underlying functional food assets, as well as shares owned in Translational Life Sciences Inc. for a combined consideration of approximately C$1.1 million plus royalty. In connection with the divestiture of the consumer division, Amber Allen has resigned as Vice President of Sales, effective January 17, 2022.
– Launched a new website at www.neonmindbiosciences.com.
– As a result of NeonMind’s growing specialty clinic operations, the Company has established its new headquarters in Oakville, Ontario. The full address is 295 Robinson Street, Suit 100, Oakville, ON L6J 1G7.
Other related developments from around the markets include:
COMPASS Pathways and Sermo, a global leader in physician insights, today announced findings from a survey of Sermo physician members that showed two thirds (66%) of doctors surveyed believe psilocybin therapy has potential therapeutic benefit for patients with treatment-resistant depression (TRD). More than 320 million people globally suffer with major depressive disorder (MDD), the leading cause of disability worldwide and one of the fastest growing mental health illnesses. About a third of these patients – 100 million people – aren’t helped by existing therapies and suffer with TRD. Psilocybin therapy is an approach being investigated for the treatment of mental health challenges, including TRD. It combines the pharmacological effects of a synthesised version of psilocybin, a psychoactive substance that is an active ingredient in some species of mushrooms, with psychological support.
The Chopra Foundation, a not-for-profit organization founded by Dr. Deepak Chopra, dedicated to improving health and well-being, today announced a partnership with Cybin Inc., a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”. The Foundation is working closely with Cybin to support education and awareness about its groundbreaking research to harness the potential of psychedelic therapies in mental health. Emerging research shows that psychedelic-assisted therapy can potentially improve the quality of life for people suffering with mental illnesses, including those specific indications that Cybin is targeting, such as Major Depressive Disorder, Alcohol Use Disorder and Anxiety Disorders. “The need for new and more effective treatments across the mental health spectrum is more urgent today than ever. Through our NeverAlone movement, we aim to combine forces with the best and brightest across businesses, policymakers, mental health professionals, and others – all with the goal of building awareness, advancing scientific research, and creating a global community to ensure widespread access to well-being resources. As the number of companies pursuing psychedelic-based therapies continues to grow, the Foundation is particularly excited about partnering with Cybin based on its commitment to global well-being and mental health,” said Dr. Deepak Chopra, The Chopra Foundation Founder, Chairman of the Board and Director.
Field Trip Health Ltd., a global leader in the development and delivery of psychedelic therapies, announced that it will begin making applications for Canadians in need to access psilocybin-assisted and MDMA-assisted therapy through Health Canada’s Special Access Program (SAP). The announcement follows amendments to the SAP announced in the Canada Gazette on January 5, 2022, which have enabled physicians in Canada to make applications to Health Canada for access to “restricted drugs”, including psilocybin and MDMA.
Mind Medicine, a clinical-stage biopharmaceutical company developing psychedelic-inspired therapies for the treatment of brain-based disorders, announced that the U.S. Food and Drug Administration (FDA) has cleared MindMed’s Investigational New Drug (IND) application, allowing the Company’s Phase 2b dose-optimization trial of MM-120 for the treatment of generalized anxiety disorder (GAD) to proceed. The previously announced clinical hold on the IND was lifted following MindMed’s rapid responses for additional information related to the participant monitoring protocol in the upcoming study. The Company is working with study investigators and clinical trial sites to prepare for participant enrollment, which is expected to start in early 2022.
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