Psycheceutical Bioscience BWVI is advancing its proprietary ketamine topical formulation into clinical studies.
The life sciences company has partnered with Australian-based contract research organization iNGENū Pty Ltd.
The exclusive agreement is set to design and conduct two Phase 1/2 clinical trials in Australia to evaluate Psycheceutical’s patented ketamine topical delivery system, NeuroDirect.
The technology is designed to deliver neuroactive compounds directly into the nerve tissue through the skin, specifically at the back of the neck, aiming at enabling immediate and sustained delivery, safe dosage control and consistent results, while avoiding systemic side effects like hallucinations, nausea and dizziness.
The study will include 20 healthy adult volunteers, each dosed with a single application of NeuroDirect ketamine, and test its safety, tolerability and pharmacokinetics.
The subsequent Phase 2 trial would involve 115 participants with PTSD and analyze the effectiveness of NeuroDirect ketamine on improving their symptoms. Importantly, this study has been designed to be considered for “pivotal clinical trial” recognition by the FDA, which would then allow Psycheceutical to proceed directly to a Phase 3 trial rather than an additional Phase 2b one, saving significant cost and time.
Furthermore, conducting the clinical trials in Australia allows Psycheceutical to take advantage of the Australian federal government's R&D tax incentive program, which will provide rebates of up to 43.5% on eligible expenditures, therefore providing the company savings to work on other novel compounds in its drug pipeline.
Psycheceutical CEO Chard Harman says the company is eager to engage in NeuroDirect’s next development phase designed “to solve the issues with side effects that most psychedelic drug development companies face, while at the same time developing lifesaving mental health treatments.”
“We’re impressed with Psycheceutical’s development of psychedelic delivery technologies which potentially offer safer and more effective dosing for patients,” iNGENū’s CEO Sud Agarwal said.
Photo: Benzinga edit with photo by geralt on Pixabay and Wikimedia Commons.
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