Psycheceutical to Conduct the First Ever Phase I and II Clinical Trials of a Novel Ketamine Topical Cream to Treat PTSD

Rhea-AI Summary

Psycheceutical Bioscience, Inc. (OTCPK: BWVI) has entered into an exclusive agreement with iNGENū Pty Ltd to conduct human clinical trials for its NeuroDirect™ ketamine topical delivery system in Australia. The Phase I trial will evaluate safety and pharmacokinetics in 20 healthy volunteers, while the Phase II trial aims to assess effectiveness in 115 PTSD patients. The company anticipates potential FDA recognition for a pivotal clinical trial, allowing a direct transition to Phase III, which could save significant time and costs. Additionally, conducting trials in Australia allows Psycheceutical to benefit from a 43.5% R&D tax rebate, reducing capital expenditure.

Positive

• Entering partnership with iNGENū to conduct clinical trials enhances credibility.
• Phase I trial will assess safety and pharmacokinetics, crucial for regulatory approval.
• Phase II trial targets PTSD, a significant market opportunity.
• Potential for FDA pivotal trial status streamlines path to Phase III.
• Tax rebate from Australian government could save 43.5% on R&D costs.

Negative

• None.

• Psycheceutical ​​enters into agreement with iNGENū to conduct ​human ​clinical trials of NeuroDirect™ ketamine topical ​in Australia
  
  
• Phase I trial will study 20 people to test the safety, tolerability, and pharmacokinetics of a single dose of NeuroDirect™ ketamine
  
  
• Phase II trial will study 115 participants with PTSD and look at the effectiveness of NeuroDirect™ ketamine on improving their symptoms
  
  

MIAMI, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc. (OTCPK: BWVI) ("Psycheceutical" or the "Company"), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health treatments, today announced it has entered into an exclusive agreement with iNGENū Pty Ltd. ("iNGENū"), an Australian-based Contract Research Organization (CRO), 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 iNGENū 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.”

“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 Psycheceutical CEO Chad Harman. “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.​​”

​​​The subsequent Phase II clinical trial, also with iNGENū, 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.

“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 Dr. Sud Agarwal, CEO of iNGENū. “We’re impressed with Psycheceutical’s development of psychedelic delivery technologies which potentially offer safer and more effective dosing for patients.”

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 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 Chad Harman, Psycheceutical CEO.

NeuroDirect™ for Non-Systemic Delivery
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.

About Psycheceutical Bioscience, Inc. 
Psycheceutical Bioscience, Inc. 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 the top minds in the psychedelic industry, 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.

About iNGENū
iNGENū is a globally-focused Contract Research Organization (CRO) working exclusively in the cannabinoid and psychedelic space. The company is a full-service CRO performing clinical trials for US, Canadian, and European sponsors in Australia. iNGENū helps companies access the advantages of conducting clinical trials in Australia, including the ability to perform FDA registration clinical trials prior to opening an IND, access to the lucrative 43.5% research and development rebate from the Australian government on all research expenses, and rapid start-up of clinical trials in under 12 weeks.

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, (vii) FDA determinations regarding how that recognize and classify one or more our clinical trials 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.

Contact:

Kaia Roman, VP, Strategy & Communications
kaia.roman@psycheceutical.com

FAQ

What is the purpose of the NeuroDirect™ ketamine clinical trials?

The trials aim to test the safety, tolerability, and effectiveness of NeuroDirect™ ketamine for treating PTSD.

How many participants will be involved in the Phase II trial of NeuroDirect™ ketamine?

The Phase II trial is planned to involve 115 participants diagnosed with PTSD.

What financial benefits does Psycheceutical expect from conducting trials in Australia?

Psycheceutical expects to save up to 43.5% on eligible R&D expenditures through the Australian government's tax incentive program.

What are the expected outcomes of the Phase I clinical trial for NeuroDirect™ ketamine?

The Phase I trial aims to evaluate the safety and pharmacokinetics of a single dose in healthy adults.

What could FDA pivotal trial recognition mean for Psycheceutical?

If recognized as a pivotal trial, Psycheceutical could proceed directly to Phase III, saving time and reducing costs associated with an additional Phase IIb trial.