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

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

MIAMI, FL / ACCESSWIRE / 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.