PsyBio Therapeutics Files Patent Application with USPTO for Production Methods of Methylated Trypatamines and Associated Analogs

PsyBio's intellectual property portfolio now includes seven pending provisionals and one pending non-provisional patent application

Company has also initiated preclinical studies aimed at treating psychologic and neurologic conditions

OXFORD, Ohio and COCONUT CREEK, Fla., Aug. 16, 2021 /CNW/ -- PsyBio Therapeutics Corp. (TSXV: PSYB, OTCQB:PSYBF) ("PsyBio" or the "Company"), an intellectual property driven biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria and other innovative mediums for the potential treatment of mental health challenges and other neurological disorders, has filed a new provisional patent application with the United States Patent and Trademark Office (USPTO) entitled Methods for the Production of a Methylated Tryptamines and Intermediates or Side Products, adding additional methylated tryptamines including compounds such as N,N-Dimethyltryptamine ("DMT") and associated analogs for development of potential treatments for a variety of human health conditions. PsyBio's intellectual property portfolio now includes seven pending provisionals and one pending non-provisional patent application.

The addition of methylated tryptamines with pending patent protection is focused on the potential improvement of treatments for mental health conditions including depression, anxiety and addiction, as well as other psychological and neurologic conditions.

DMT, as an example of a methylated tryptamine, is a tryptophan-derived alkaloid naturally present in certain plants and animals. DMT has an extensive history of being ingested as a mixture called Ayahuasca among several indigenous groups from the Northwestern Amazon for therapeutic purposes. Ayahuasca is a combination of DMT, made from the leaves of the shrub Psychotria viridis, and monoamine oxidase inhibitors required for DMT work, from the vine Banisteriopsis caapi. As a structural analog of serotonin, DMT binds a subset of serotonin receptors in the brain which is believed to be the basis for its purported therapeutic effect.

"This innovative technology adds a wide range of new potential drug candidates to PsyBio's portfolio of microbially derived small molecules," said Dr. J. Andrew Jones, Chairman of the PsyBio Scientific Advisory Board and Co-Inventor on the provisional patent application. "Leveraging the scalability and speed of a bacterial biosynthetic approach for these compounds is expected to lead to a cost competive synthesis with reduced environmental impact over current production methods."

PsyBio has leveraged its expertise in synthetic biology, metabolic engineering, biomedicinal chemistry, clinical pharmacology and drug development using genetically modified organisms and, when appropriate, targeted synthesis to produce DMT and other relevant target analogs for potential therapeutic treatment of mental health challenges and other neurological disorders. PsyBio has filed intellectual property on a method for the production of a methylated tryptamine or an intermediate thereof utilizing a prokaryotic host. PsyBio intends to continue utilizing its resources to rapidly develop and test new drug candidates within this and other psychedelic categories in anticipation of launching future clinical trials.

"PsyBio continues to build a highly talented in-house team of world class scientists, engineers, medicinal chemists and pharmacology experts enabling the Company to build its intellectual property portfolio of novel drug candidates," stated Evan Levine, PsyBio's Chief Executive Officer. "The Company by design has high quality internal resourses to discover and actively screen compounds that could possibly have a positive impact on human health across a variety of medical indications. The Company is conducting scientifically designed experiments to leverage these new innovations and plans to move target candidates into scaled commercial manufacturing and regulatory application upon rigorous preclinical safety and efficacy testing, identifying a confirmed signal in one of our selected indications and receipt of all necessary regulatory approvals."

"PsyBio's strategy is to continually expand its drug discovery portfolio by adding additional classes of molecular targets, including methylated tryptamines such as DMT and related compounds," said Michael Spigarelli, PsyBio's Chief Medical Officer. "This concept allows PsyBio to prioritize selection and indication matching, moving the safest and most active single agent and combination therapeutic candidates forward into clinical trials."

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an intellectual property driven biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria for the potential treatment of mental health challenges and other disorders. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company is also researching and developing new non-naturally occurring molecular structures which may have unique therapeutics properties.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute "forward-looking information" ("forward-looking information") within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file its initial pre-Investigational New Drug ("IND")  Application request and IND Application within anticipated timeframes; PsyBio will be successful in obtaining IND Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio's technology will be safe and effective; a confirmed signal will be identified in PsyBio's selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio's business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio's proposed products. The United States Food and Drug Administration ("FDA") or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio's performance and operations.

The TSX Venture Exchange ("TSXV") has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release. 

SOURCE PsyBio Therapeutics Corp.