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Psycheceutical Announces Successful First Cohort Dosing; Moves to Dose Escalation in Phase I Trial of NeuroDirect Ketamine for PTSD

Company's novel NeuroDirectTM topical ketamine formulation to treat PTSD shown to be safe and well-tolerated in first cohort of Phase I trial.

MIAMI, FL – August 10, 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 the completion of dosing of the first cohort of subjects in a Phase I clinical trial of its patented NeuroDirect™ topical ketamine formulation for the treatment of Post Traumatic Stress Disorder (PTSD). NeuroDirect ketamine is the company’s lead non-systemic drug candidate designed to target free nerve endings at the back of the neck, with the objective of delivering ketamine safely, effectively and without hallucinogenic effects.

Key results from first cohort include:

  • The topical administration of the NeuroDirect ketamine was shown to be safe and well-tolerated.
  • No clinically relevant adverse events or psychotomimetic effects were seen, giving the Safety Review Committee confidence to proceed with an escalation of the dosage for the second cohort.
  • The viability of topical administration was confirmed when anticipated pharmacokinetics (PK) aligned well with the observed PK parameters in cohort 1, bolstering confidence for replication with increased dosage in cohort 2.

“We are excited about the overall success of our first cohort from our Phase I clinical trial,” said Chad Harman, CEO of Psycheceutical. “The favorable safety profile for our topical NeuroDirect ketamine represents an exciting milestone in our goal of bringing to market a novel method for treating mental health and neurodegenerative diseases. We look forward to expanding our drug pipeline with other psychedelic compounds using this novel delivery method in the near future.”

Psycheceutical’s clinical trial program is the first ever to test the topical application of ketamine for use in treating a mental health disorder. 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 participants. The company’s first cohort included six trial participants who were given a topical dose of NeuroDirect ketamine and underwent a thorough safety assessment for 12 days. Topical ketamine was shown to be safe and well-tolerated for all cohort 1 participants. This data gave the trial’s Safety Review Committee assertive confidence to proceed with an increased dosage for cohort 2. Full details on the clinical trial can be found here.

NeuroDirect ketamine is the first of several opportunities in the company’s drug pipeline designed to treat mental health and neurodegenerative disorders. Psycheceutical’s delivery technologies have been featured in numerous publications including Forbes, BioSpace, Pharmacy Times, Drug Development & Delivery, Genetic Engineering & Biotechnology News, Benzinga, and more. The company was recently named a Top 10 Biotech Startup for 2023 by Life Sciences Review. The company has attracted the attention of investors like Kevin Harrington from Shark Tank and the Chief Medical Officer is neurosurgeon Dr. Julian Bailes who was portrayed by Alec Baldwin in the movie Concussion.

NeuroDirect for Non-Systemic Delivery
Psycheceutical’s NeuroDirect non-systemic delivery technology is designed to deliver neuro-affective compounds directly into the nervous system through a topical application at the back of the neck. This delivery system is intended to enable immediate 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, thereby increasing access to these life-saving treatments for anyone suffering from mental health or neurodegenerative disorders.

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.

Media Relations: Contact Psycheceutical, Inc.

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