The world is in desperate need for new treatments for major issues, such as mental health and obesity. That’s where companies, such as NeonMind Biosciences (CSE:NEON) (OTC:NMDBF), Cybin Inc. (NEO:CYBN)(OTC:CLXPF), Tryp Therapeutics Inc. (CSE:TRYP), Mind Medicine Inc. (NEO:MMED)(OTC:MMEDF), and Compass Pathways (NASDAQ:CMPS) can come into play and hopefully assist millions of people in need.
The obesity epidemic for example, is bursting at the seams. According to the World Health Organization (WHO) obesity has tripled in size over the last 50 years. In 2016, they note, 1.9 billion adults were overweight around the world. Of those, 650 million were considered obese. Just in the U.S., nearly 34% of adults and up to 20% of children are obese. By 2030, almost half of U.S. adults will be considered obese. By 2030, almost half of U.S. adults will be obese.
That’s where a company like NeonMind Biosciences (CSE:NEON)(OTC:NMDBF) could help
At the moment, the company is exploring psilocybin as a potential treatment for obesity and to support weight loss. In fact, 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. The second drug candidate employs psilocybin as an agonist to the serotonin 5-HT2C receptor, which controls appetite.
In addition, NeonMind Biosciences just announced that on March 10, 2021, NeonMind engaged Certara®, the global leader in model-informed drug development to provide strategic integrated drug development support for the investigation of NeonMind’s psilocybin based drug candidates for the treatment of obesity.
NeonMind is exploring psilocybin as an innovative treatment approach to support weight loss. NeonMind’s first drug candidate aims to use synthetic psilocybin to enhance a patient’s ability to alter behaviours that cause weight loss through psychedelic-assisted cognitive therapy. The second drug candidate proposes low dose synthetic psilocybin as a treatment to suppress appetite.
“Certara has the expertise, technology and network to further our drug development efforts to help us achieve our goals of progressing psilocybin-based weight loss treatments through the rigorous drug development process,” said Rob Tessarolo, President & CEO of NeonMind. “We are assembling world-class R&D capabilities dedicated to creating a dossier of scientific evidence to support regulatory approval for these novel treatments that can positively impact millions of people.”
The typical roadmap to regulatory submission for a product involves a sponsor like NeonMind to complete a complex interconnected sequence of evaluations on the product’s quality (CMC – chemistry, manufacture, and controls), preclinical efficacy, safety pharmacology and toxicology, and preclinical and clinical pharmacological characterization.
The evaluations and their sequence are established in an integrated drug development plan by a cross-functional team of experts.
Pursuant to the engagement, NeonMind with access to global leaders in drug development strategy, due diligence, toxicology, clinical pharmacology, regulatory science, and the full spectra of drug development subject matter experts across Certara.
Certara provides biosimulation software to transform traditional biopharmaceutical R&D with a scientific team that has more than 3,500 years of collective drug discovery and development experience. Since 2014, 90% of new drug and biologic approvals by the US FDA have been received by Certara’s customers.
Other related developments from around the markets include:
Cybin Inc. announced that Adelia Therapeutics Inc., a wholly-controlled subsidiary of Cybin, has achieved certain earn-out milestones for the period commencing January 1, 2021, as contemplated by the terms of a contribution agreement dated December 4, 2020 among Cybin, Cybin Corp., Cybin US Holdings Inc., a wholly-controlled subsidiary of Cybin, and all of the previous shareholders of Adelia. The achievement includes API Synthesis and optimization to demonstrate that two or more deuterated tryptamines show significant in vivo modifications of PK consistent with “Proof of Concept”, nomination of two deuterated candidates for full IND enabling studies, and completion of a certain API Manufacturing Contract.
Tryp Therapeutics Inc. just announced that Albany Molecular Research has begun the process of manufacturing the 200g non-GMP demonstration batch of psilocybin. This production step is one of a series of steps in the project plan to manufacture batches of Tryp's proprietary formulation of cGMP psilocybin to support the company's clinical development and for the company's upcoming clinical trials. "AMRI is proud to support Tryp Therapeutics in their mission to address diseases with highly unmet needs through the rapid development and scale-up of a novel process to advance Psilocybin into human clinical trials," said Christopher Conway, president, AMRI. "We are leveraging our core expertise in process development and cGMP manufacturing to help progress Tryp's clinical pipeline."
Mind Medicine Inc., a leading psychedelic medicine biotech company, is pleased to announce that it has closed the previously announced acquisition of HealthMode, a digital medicine and therapeutics startup that uses Artificial Intelligence (AI)-enabled digital measurement to increase the precision and speed of clinical research and patient monitoring. MindMed Co-Founder and CEO J.R. Rahn said: “The HealthMode acquisition marks the start of MindMed 2.0 as we seek to not only build a drug development company for psychedelic medicines, but also a comprehensive mental health technology platform to one day potentially launch these transformative medicines to patients in a scalable manner.”
Compass Pathways reported its financial results for the fourth quarter and year-end 2020 and gave an update on recent progress across its business. George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “Mental health is an urgent crisis and this has only been exacerbated by the COVID-19 pandemic. At COMPASS we remain committed to transforming mental health care and helping patients who are suffering and aren’t helped by existing treatments. Our phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression is actively recruiting and we plan to report data from this trial at the end of the year. We are also continuing preclinical research into new indications, new compounds and new technologies, working with partners through our Centre of Excellence, our Discovery Center, and a number of investigator-initiated studies, as well as developing a strong team.”
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