The obesity epidemic in the U.S. is only getting worse. In fact, by the time 2030 rolls around, nearly half of all U.S. adults are projected to be obese, according to Harvard researchers, as noted by MSN. While some companies have suggested using “magnets cemented to your teeth to stop you opening your mouth by more than a couple of millimeters,” as reported by The Guardian, other companies believe the use of psilocybin could be far more beneficial. That could be great news for companies such as NeonMind Biosciences (CSE:NEON)(OTC:NMDBF), ATAI Life Sciences (NASDAQ:ATAI), Mind Medicine (NASDAQ:MNMD)(NEO:MNMD), Cresco Pharma Ltd. (OTC:COPHF), and Pharmather Holdings Ltd. (CSE:PHRM)(OTC:PHRRF).
NeonMind Biosciences, for example, has two drug development candidates exploring psilocybin as an innovative treatment approach to treat obesity and support weight loss. NeonMind’s first drug candidate employs psilocybin as an agonist to the serotonin receptor 5-HT2A, which is involved in the hallucinogenic effect of psychedelics, and the second drug candidate employs psilocybin as an agonist to the serotonin 5-HT2C receptor, which controls appetite.
NeonMind Just Provided an Integrated Drug Development Plan Update To Treat Obesity
NeonMind Biosciences, an integrated drug development and wellness company focused on the potential therapeutic uses of psilocybin for treating obesity and weight management conditions, announced today its R&D Working Group has completed an integrated drug development plan for its lead drug candidate targeting obesity, NEO-001, a high-dose psilocybin treatment coupled with behavior 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; it believes will best position NeonMind as it advances its first lead candidate through development.
The Company is targeting a Pre-IND meeting with the U.S. Food and Drug Administration (FDA) in Q4 2021 to confirm potential to expedite development via the appropriate regulatory pathway and a Pre-CTA Consultation Meeting with Health Canada during the same timeframe. NeonMind anticipates initiating a Phase 1/2 proof-of-concept study in obese patients in the first half of 2022.
NEO-001, the Company’s high-dose psilocybin treatment, is intended for use as an adjunct to behavioral therapy and to accompany a reduced-calorie diet and increased physical activity for adults with an initial body mass index (BMI) of 30 kg/m2 or greater, or a BMI of 27 kg/m2 or greater and at least one weight-related, comorbid condition. The Company’s target product profile aims to best address the psychological and behavioral deficiencies in the current standard of care for chronic weight management.
It has been demonstrated that one of the most prevalent and often forgotten drivers of weight management issues is psychological and behavioral shortcomings. In clinical studies, psilocybin has shown promising results in addressing these shortcomings in other indications. In addition, improving weight management has many benefits in addressing highly burdensome and detrimental comorbidities particularly in those individuals with hypertension, dyslipidemia, type 2 diabetes, and psychiatric disorders. These additional indications are available to the Company’s program and provide potential opportunities to expand the range of clinical targets.
"Growing evidence supports the therapeutic promise of psilocybin as a psychiatric tool that can help facilitate cognitive flexibility and behavioral plasticity. Recent clinical and neuroimaging data suggest persisting changes in patterns of brain function after a single high dose of psilocybin, which are associated with enhanced mood and changes in emotional processing and anxiety. These shifts have been hypothesized to work as a sort of 'mental reset' that could have significant therapeutic potential for other health conditions like obesity," said Dr. Albert Garcia-Romeu, Assistant Professor of Psychiatry and Behavioral Sciences at the Johns Hopkins Center for Psychedelic & Consciousness Research and advisor to NeonMind. "NeonMind's research approach will add meaningfully to our knowledge of psilocybin as a medical tool, and I'm excited by the prospects of NeonMind's program for expanding therapeutic psilocybin research to novel areas such as weight management, where innovative treatments are needed.”
“Our innovative obesity drug candidate has the potential to generate durable weight loss in adults, which has been a long-standing gap in the current landscape of weight management methods and treatments,” said Robert Tessarolo, President & CEO of NeonMind. “NeonMind’s ultimate mission is to help people change their lives by changing their minds, through novel treatments with psychedelics. We are eager to embark on this regulatory journey, as we move one step closer to bringing psilocybin to patients who need it most. Our psilocybin-assisted treatment program has significant potential, and we believe it is going to bring a new therapeutic modality to the broader healthcare industry for the treatment of obesity and related comorbidities.”
Other related developments from around the markets include:
ATAI Life Sciences, a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced the pricing of its upsized initial public offering in the United States of 15,000,000 common shares at a price to the public of $15.00 per share. All common shares are being offered by atai. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by atai, are expected to be $225.0 million. In addition, atai has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 common shares at the initial public offering price, less underwriting discounts and commissions. The offering is expected to close on June 22, 2021, subject to customary closing conditions.
Mind Medicine, a leading biotech company developing psychedelic-inspired therapies, and Datavant, Inc., a leader in helping healthcare organizations safely connect their data, announced a partnership through which MindMed will use Datavant’s privacy-protecting technology to link MindMed’s clinical trial data to external data from both clinical and real-world sources. MindMed plans to use Datavant’s linking technology across various stages of the drug lifecycle including discovery, clinical development, and commercialization. Data linking will allow MindMed to create broad and detailed datasets to better understand the real-world treatment, service utilization, and healthcare experiences of patients with psychiatric and substance use disorders. This data, and the deeper understanding of both the relevant illness and the paths of care through which patients proceed, will help enhance MindMed’s clinical trial planning, execution, and preparation for commercialization of its novel molecules.
Cresco Pharma Ltd. announced that it has completed the acquisition of established Canadian psychedelics company Halucenex Life Sciences. The completion of the transaction follows considerable due diligence undertaken by Creso Pharma. The acquisition marks an important milestone, as it provides direct access to the emerging psychedelic-assisted psychotherapy (PAP) sector and unlocks a number of opportunities for the Company in the near term and following Creso Pharma’s potential merger with Red Light Holland.
Pharmather Holdings Ltd., a clinical-stage psychedelics biotech company, announced that it has filed a provisional patent application with the U.S. Patent and Trademark Office outlining a novel formulation of ketamine for intradermal administration as potential treatments for mental health, neurological and pain disorders. The Company’s intellectual property portfolio includes 19 granted patent and patent applications filed in over 150 countries. Fabio Chianelli, CEO of PharmaTher, commented: “As we continue to advance our clinical programs with ketamine, we are building a robust intellectual portfolio of potential prescription-based ketamine products and psychedelics through novel uses, formulations and delivery forms to treat various diseases and disorders. I am pleased with our continued dedication to becoming a leader of novel ketamine products and implementing a patent strategy that would protect our clinical development and commercialization initiatives.”
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