The obesity epidemic is still bursting at the seams. In fact, according to Medical News Today, the issue contributes to more than five million global deaths every year. In addition, according to the World Health Organization, obesity has tripled since 1975. More than 1.9 billion adults were overweight, as of 2016, with more than 650 million considered obese. Plus, more than 340 million children were considered overweight in 2016. Fortunately, companies like
NeonMind Biosciences (CSE:NEON)(OTCQB:NMDBF) believe psychedelics drugs, like psilocybin could be key to significantly reducing obesity statistics. Other companies to watch include Cybin Inc. (NEO:CYBN)(NYSE:CYBN), Mind Medicine Inc. (NEO:MMED)(NASDAQ:MNMD), ATAI Life Sciences (NASDAQ:ATAI), and Pasithea Therapeutics Corp. (NASDAQ:KTTA).
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind’s lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company’s second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
Look at NeonMind Biosciences (CSE:NEON)(OTCQB:NMDBF)
NeonMind Biosciences, for example, an integrated drug development and wellness company focused on the potential therapeutic uses of psilocybin for treating obesity and weight management conditions, announced today it successfully completed a pre-Investigational New Drug (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 initiate a Phase 1/2 clinical study in the first half of 2022.
“We are extremely pleased with the FDA’s feedback and the outcome of the pre-IND consultation, which validated the scientific hypothesis and clinical approach developed by the NeonMind team. The FDA provided helpful feedback and constructive recommendations for the next steps in our development plan. We appreciate the FDA’s guidance and are on track to bring the first and only psychedelic-based treatment for obesity into clinical trials,” said Robert Tessarolo, President & CEO of NeonMind. “In parallel with an IND submission in Q1 2022, we plan to engage with a Contract Research Organization and qualify clinical sites to move expeditiously into a Phase 1/2 Proof-of-Concept study.”
The pre-IND consultation offered feedback for NeonMind to execute on measurable clinical development milestones for its NEO-001 clinical program. The FDA acknowledged the study rationale and potential therapeutic opportunity of NEO-001 for the treatment of obesity, and the justification to advance into human clinical trials. NeonMind will incorporate the FDA’s recommendations and does not expect any impact on the timing of the proposed NEO-001 clinical program. NeonMind’s proprietary therapy will be the first psychedelic program in humans to target a large population of patients struggling with sustainable weight management.
NEO-001, the Company’ lead drug candidate targeting obesity, is a high-dose psilocybin treatment coupled with behavioral therapy and lifestyle intervention, which aims to improve the efficacy of chronic weight management in adults. The Company has identified a regulatory strategy, including a target indication and product profile, which it believes will best position NeonMind as it advances its first lead candidate through development.
Other related developments from around the markets include:
Cybin Inc., biopharmaceutical company focused on progressing “Psychedelics to Therapeutics” reported unaudited financial results for its second quarter ended September 30, 2021. “The first half of the year has been a transformative period for Cybin that included significant and swift advancements in our research and development pipeline and overall business. Through CYB003, we believe that we have identified a potentially safer treatment option for patients with depression and addiction disorders that we expect to have strong intellectual property protection and a positive pharmacokinetic profile for patients, providers and payers. We plan to move through the ongoing, remaining preclinical studies quickly and submit an investigational new drug application and clinical trial application in the second quarter of 20221, in the U.S. and the U.K., respectively,” said Doug Drysdale, Chief Executive Officer of Cybin.
Mind Medicine Inc., a leading biotech company developing psychedelic-inspired therapies, is pleased to announce it has launched recruitment for a randomized placebo-controlled study evaluating the effects of daytime and evening administration of repeated low doses of LSD. Researchers will use digital measurement devices and software to measure the effects of microdoses of LSD on neuroplasticity markers such as BDNF plasma levels, as well as on various sleep measures, mood, cognitive performance, regulation of emotions, quality of life, and immune system response. The study will be conducted by Dr. Kim Kuypers of Maastricht University, a leading global authority on the use of low dose psychedelics.
ATAI Life Sciences, a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, reported its financial results for the third quarter ended September 30, 2021, and provided its corporate update. “Following our IPO in June, we continue to see positive momentum. We have 11 therapeutic programs underway and each clinical development milestone marks progress towards achieving our vision to heal mental health disorders so that everyone, everywhere can live a more fulfilled life,” said Florian Brand, CEO and Co-Founder. “In response to the heterogeneity of the mental health patient population, we are developing a pharmacologically diverse array of treatments. We intend to support these treatments with innovative digital therapeutics and robust insights from our multi-modal data approach. Our goal is to tailor our treatments to individual patient needs by using a diverse set of biomarkers. We anticipate further growth of our drug development pipeline and our enabling technologies through our ‘buy and build’ approach and will remain highly active in business development.
Pasithea Therapeutics Corp., a biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, announced the formation of its Scientific Advisory Board to be chaired by esteemed psychiatrist, Charles Nemeroff, M.D., Ph.D. The newly formed SAB will work closely with Pasithea management to provide direction and support as the Company advances its mission of developing drugs that target the pathophysiology underlying psychiatric and neurological disorders.
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