Oxford, OH And Coconut Creek, FL /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), an intellectual property driven biotechnology company developing novel, bespoke, fully approved, psycho-targeted therapeutics to potentially improve mental and neurological health, today reported it has submitted its first pre-Investigational New Drug ("IND") application meeting request to the United States Food and Drug Administration ("FDA") as part of the regulatory submission process.
The FDA's Pre-Investigational New Drug Application (IND) Consultation Program fosters early communications between sponsors and new drug review divisions to provide guidance on the data necessary to warrant IND submission.1 PsyBio is dedicated to working towards obtaining all necessary regulatory approvals for its therapeutics under development and intends to submit its most promising potential therapeutic candidates to the appropriate regulatory body as part of the approval process. The submission of this pre-IND meeting request for collaborative discussions with the FDA has been submitted in anticipation of filing the first of several clinical IND packages.
"This is a significant milestone for PsyBio as there are currently no approved indications for psilocybin or other similar compounds," stated Michael Spigarelli, MD, PhD, MBA, PsyBio's Chief Medical. "We look forward to working with the FDA to define what would be considered sufficient proof of safety and efficacy within the target populations. This is the first step to defining an acceptable medical use for these compounds, a critically necessary component in order to facilitate further developing and manufacturing at the necessary scale for this new class of potential therapeutics."
"This submission firmly establishes PsyBio among the top biotechnology companies actually seeking regulatory approval for their psychoactive therapeutic candidates," stated Evan Levine, Chief Executive Officer, PsyBio. "The Company's logical and validated testing approach allows PsyBio to effectively design and develop therapeutics to potentially treat specific clinical conditions and submit those to the appropriate regulatory agencies for approval and marketing authorization. PsyBio is doing this as part of our commitment to research and develop potential therapeutics for mental and neurological health."
About PsyBio Therapeutics Corp.
PsyBio is an intellectual property driven biotechnology company developing novel, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health. 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 utilizes a Bio Medicinal Chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring.
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 competitive 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; pre-IND consultation with the FDA will be productive and yield favourable results; PsyBio will file its 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 FDA 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 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.
1 https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application - accessed 22SEP2021