First Patient Dosed in Psycheceutical's Phase I Study Exploring Topical Administration of Ketamine to Treat PTSD

Psycheceutical's clinical trial program is the first ever to test the topical application of ketamine for use in treating a mental health disorder through the company's NeuroDirect™ delivery system.

MIAMI, FL / ACCESSWIRE / July 13, 2023 / Psycheceutical Bioscience, Inc ("Psycheceutical" or the "Company") (OTC PINK:BWVI), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health treatments, today announced that the first patient has been dosed in its Phase I study to evaluate its patented NeuroDirect™ ketamine topical delivery system for the treatment of Post Traumatic Stress Disorder (PTSD). NeuroDirect ketamine is the company's first non-systemic drug candidate designed to target free nerve endings on the back of the neck, with the objective of delivering psychedelic medicines safely, effectively and without hallucinogenic effects.

The goal of the Phase I study, which is being conducted by iNGENū Pty Ltd. in Australia, is to test the safety, tolerability, and pharmacokinetics of NeuroDirect ketamine in 24 healthy adult volunteers. Psycheceutical's clinical trial program is the first ever to test the topical application of ketamine for use in treating a mental health disorder.

"Today's achievement marks our transition to a clinical-stage company and represents an important milestone for Psycheceutical, and more importantly for those individuals who seek a safe, alternative therapy to improve their mental health," said Chad Harman, CEO of Psycheceutical. "With our goal of a non-systemic treatment for PTSD using legal ketamine, we are attempting to pave the way for our future drug candidates to treat other mental health disorders."

The Phase I clinical trial builds on the recent positive results of a observational preclinical study published in Drug Development and Delivery that describes the potential of NeuroDirect ketamine topical cream as an improved treatment for PTSD. In the study of 100 patients who hadn't responded to traditional therapies, more than 80% trying NeuroDirect ketamine topical found it effective at treating their symptoms. As described in the study, "Discernible improvement[s] in anxiety, depression, paranoia and unrealistic fear, focusing issues, cloudy thinking, neuro­pathic pain, and other such symptoms were noted within 8-10 minutes of topical drug application. No psychogenic effects, such as hallucinations or dissociative phenomena, were experienced by any patient. To the contrary, patients indicated their thought processes were clearer, more focused, and that they were more keenly aware of surroundings."

Multi-Billion Dollar PTSD Market

The global PTSD treatment market size was valued at $16.0 billion in 2021 and is projected to reach $26.1 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.9% (Vikita et al., 2022). With millions of people around the world suffering from PTSD, and no effective therapeutics currently available, Psychceutical's hope is that NeuroDirect ketamine could revolutionize the PTSD treatment market.

The company has already achieved important milestones in its push to commercialize its unique product, with initial discussions held with the U.S. Food and Drug Administration (FDA) where a 505(b)(2) pathway has been identified for obtaining regulatory approvals.

NeuroDirect™ for Non-Systemic Delivery

Psycheceutical's NeuroDirect™ non-systemic delivery technology is designed to deliver neuro-active compounds directly into the nerve tissue via topical application at the back of the neck. This delivery system is intended to enable immediate and sustained delivery, safe dosage control, and consistent results, while avoiding the systemic side effects of psychedelic compounds such as hallucinations, nausea, and dizziness. NeuroDirect™ is designed to be administered at home instead of a clinical setting, greatly lowering the cost of care for both insurance companies and patients, increasing access to these life-saving treatments for anyone suffering from mental health disorders or central nervous system diseases.

About Psycheceutical Bioscience, Inc.
Psycheceutical Bioscience, Inc. (OTC PINK:BWVI) is developing cutting-edge technologies to advance the safe and effective delivery of psychedelic pharmaceutical medicines. Powered by a team of FDA drug development veterans, biotechnology experts, and top neuroscientists, Psycheceutical is on a mission to commercialize its precision dosing technologies to provide affordable, life-saving treatments to anyone suffering from mental health disorders or central nervous system diseases. Learn more at Psycheceutical.com.

Forward-Looking Statements:
Certain statements in this news release related to the Company constitute "forward-looking information" within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These uncertainties include, but are not limited to, (i) general market growth for and acceptance of psychedelic-inspired medicines, (ii) capital and credit availability and market volatility, (iii) general economic conditions, (iv) governmental approvals and compliance with regulations, (v) product research and development and clinical trial risks, (vi) incorrect underlying assumptions, and (vii) our future business development, results of operations, and financial condition. These statements generally can be identified using forward-looking words such as "will," "may," "should," "could," "intend," "estimate," "plan," "anticipate," "expect," "believe," "potential" or "continue," or the negative thereof or similar variations. All information provided in this press release is as of the date of this press release, and we undertake no duty to update such information, except as required under applicable law.

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SOURCE: Psycheceutical, Inc.