Vancouver, B.C. – March 11, 2021: NeonMind Biosciences Inc. (CSE: NEON) (OTC: NMDBF) (FRA: 6UF) (“NeonMind”) is pleased to announce 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.
About NeonMind Biosciences Inc.
NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind’s first drug candidate aims to use synthetic psilocybin to enhance a patient’s ability to adopt 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.
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 5-HT2C receptor, which controls appetite.
NeonMind has an intellectual property portfolio which includes uses of psychedelic compounds for the treatment of compulsive eating disorder, obesity and related complications, to aid in weight loss, reduce food cravings, decrease food intake and to alter diet. NeonMind has filed 10 US provisional patent applications for psychedelic compounds, of which 2 have been converted to PCT applications, with potential rights in 152 countries. NeonMind’s first PCT patent application covering the administration of psilocybin and its analogs to treat obesity and compulsive eating disorder has a priority date of December 4, 2019. The anticipated patent protection expiry of these pending patents is 2041.
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Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind’s future performance. The use of any of the words “could”, “expect”, “believe”, “will”, “projected”,”estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind’s drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
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