BLUE WATER VENTURES INTERNATIONAL, INC. Psycheceutical Bioscience, Inc. announced it has entered into an exclusive agreement with iNGENu Pty Ltd., to design and conduct two clinical trials to evaluate Psycheceutical's patented NeuroDirect™ ketamine topical delivery system. Psycheceutical?? ?is planning to conduct the clinical trials in ??Australia.
The first in-human, Phase I clinical trial with iNGENu is studying 20 people, each dosed with a single application of NeuroDirect™ ketamine. This trial is designed to test the “Safety, Tolerability, and Pharmacokinetics of NeuroDirect Ketamine in Healthy Adult Volunteers.” The subsequent Phase II clinical trial, also with iNGENu, is targeted to involve 115 participants with PTSD and to analyze the effectiveness of NeuroDirect™ ketamine on improving their symptoms. This trial has been designed to be considered for “pivotal clinical trial” recognition by the FDA, which would then allow the Company to proceed directly to a Phase III clinical trial rather than an additional Phase IIb clinical trial, thereby saving the Company significant cost and time. By conducting its clinical trials in Australia, Psycheceutical can take advantage of the Australian federal government's Research & Development Tax Incentive Program, which will provide rebates to the Company of up to 43.5% on eligible expenditures for research and development conducted in Australia.
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.
