In a press release issued on February 15, Psycheceutical Bioscience, in partnership with iNGENū, a contract research organization in the cannabinoid and psychedelic space, has announced their agreement to design and conduct two clinical trials to evaluate Psycheceutical’s patented NeuroDirect ketamine topical delivery system for the treatment of post-traumatic stress disorder (PTSD). Psycheceutical, focused on developing next generation mental health treatments is planning to conduct the clinical trials in Australia.

The company’s patented NeuroDirect technology is a non-systemic delivery system that is being developed to deliver psychedelic medications directly to the brain, potentially avoiding drug distribution throughout the body and unwanted toxicities and side effects. The process uses a topical compound applied to the skin at the hair line at the back of the neck. Neuro-effective compounds pass into the epidermis layer of the skin and bind to receptors on free nerve endings. Neurochemical reactions occur, producing nerve impulses that travel from the peripheral nerves to the spinal cord and into the brain. The clinical trials will confirm whether the technology can bypass the blood brain barrier in humans to produce therapeutic effects.

The novel 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, lowering the cost of care for insurance companies and patients, increasing access to these life-saving treatments for anyone suffering from mental health disorders.

The first in-human, Phase I clinical trial will study 20 people to test the safety, tolerability, and pharmacokinetics of a single dose of NeuroDirect ketamine in healthy adult volunteers, while the Phase II trial will study 115 participants with PTSD to test the effectiveness of NeuroDirect ketamine on improving symptoms.

“We’re thrilled to have partnered with iNGENū as we move our proprietary delivery technology into human clinical trials. iNGENū is an industry leading, full-service CRO providing end-to-end services for companies like ours developing psychedelic drugs. Together, we’re committed to discovering new psychedelic therapies for mental health disorders and central nervous system diseases,” said Chad Harman, CEO at Psycheceutical.

“We’re eager to engage in this next phase of the development of our NeuroDirect delivery system, which we’re designing to solve the issues with side effects that most psychedelic drug development companies face, while at the same time developing lifesaving mental health treatments,” said Harman.

The subsequent Phase II trial has been designed to be considered for “pivotal clinical trial” recognition by the FDA, which would allow the company to proceed directly to a Phase III clinical trial rather than an additional Phase IIb clinical trial, saving significant cost and time.

“Our team is excited to partner with Psycheceutial for their clinical development needs, and we look forward to working together to design and conduct trials with our partners here in Australia,” said Sud Agarwal, MBBS, CEO of iNGENū. “We’re impressed with Psycheceutical’s development of psychedelic delivery technologies which potentially offer safer and more effective dosing for patients.”

Conducting the clinical trials in Australia, allows Psycheceutical to take advantage of the Australian federal government’s Research & Development Tax Incentive Program, which will provide rebates of up to 43.5 percent on eligible expenditures for research and development conducted in Australia.

“This saves us a considerable amount of capital for the research and development of other novel compounds in our drug pipeline,” said Harman.

The NeuroDirect technology could potentially lower doses of psychedelic therapeutic compounds, improving efficacy and immediacy of action. If successful in clinical trials, NeuroDirect ketamine will be the first ketamine topical cream for treating a mental health issue.

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