Psycheceutical Hosts MAPS Founder and Psychedelic Industry Leader Rick Doblin at Its Drug Development Lab

Rhea-AI Summary

Psycheceutical Bioscience (OTC: BWVI) is advancing its NeuroDirect™ ketamine topical cream aimed at treating PTSD. Recently, Rick Doblin, founder of MAPS, visited the company's lab to discuss the technology. The NeuroDirect delivery system promises to administer psychedelic compounds non-invasively, potentially minimizing side effects. Preliminary data show that 80% of patients in pre-clinical studies reported significant PTSD relief without psychoactive effects. The company is preparing to initiate clinical trials in Q2 2023. This innovation may improve treatment efficacy and reduce costs for patients.

Positive

• NeuroDirect ketamine cream shows potential for PTSD treatment, with 80% of patients reporting relief.
• Plans to begin clinical trials in Q2 2023 for the topical cream.
• Rick Doblin's endorsement highlights the innovative nature of the product.

Negative

• None.

Doblin commented on the potential of the company’s NeuroDirect™ ketamine topical cream to help those suffering from PTSD

Psycheceutical Chief Visionary Officer Zappy Zapolin and CEO Chad Harman with MAPS Founder Rick Doblin

MIAMI, March 29, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc. ("Psycheceutical" or the "Company") (OTC: BWVI), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health treatments, hosted Rick Doblin, the Founder and President of the Multidisciplinary Association for Psychedelic Studies (MAPS), at one of the company’s drug development lab sites to discuss Psycheceutical’s current development efforts related to its novel NeuroDirect™ ketamine topical cream for the treatment of PTSD.

Rick Doblin is considered one of the most influential advocates of psychedelic medicine and an industry pioneer. With over four decades of work advancing the therapeutic use of psychedelics, Doblin has moved the legalization of psychedelic medicines forward more than any other individual.

“We’re honored that Rick Doblin, who many consider to be the modern godfather of the psychedelic movement and industry, took the time to visit with our team and learn about Psycheceutical’s NeuroDirect technology,” said Chad Harman, CEO of Psycheceutical.

The Psycheceutical team educated Doblin about the company’s patented NeuroDirect delivery system and its current and planned development efforts to test the NeuroDirect delivery system with a ketamine topical cream, focusing on what it believes makes the potential treatment unique compared to other ketamine treatments. Preclinical study results have Psycheceutical excited that its NeuroDirect delivery system could improve mental health treatments by potentially delivering psychedelic medicines safely and effectively, without hallucinogenic effects and reduced side effects and toxicities.

“I enjoyed visiting Psycheceutical’s lab and meeting some of the team behind the NeuroDirect ketamine cream. I’ve been working in psychedelics for more than 40 years, and it’s rare for me to come across something unique like the NeuroDirect topical cream that is currently being developed by Psycheceutical with the goal of delivering a psychedelic compound without a psychedelic experience or negative side effects,” said Rick Doblin.

The team also discussed Psycheceutical’s plans to begin clinical trials in Q2 for its NeuroDirect ketamine topical cream as a treatment for PTSD. The novel topical cream has already shown positive pre-clinical results, as seen in observational data published in the March 2023 issue of Drug Development & Delivery Journal.

The pre-clinical study provided preliminary indications that has management believing that the NeuroDirect ketamine topical cream could prove to be more cost-effective and lead to better patient outcomes than currently available systemic ketamine treatments for PTSD symptoms. The study also showed that 80% of 100 patients relayed that they experienced significant relief from PTSD symptoms within minutes of application, while also noting they experienced no psychoactive effects. While these are results from one pre-clinical study, they have Psycheceutical focused on moving as rapidly as possible into clinical phase testing and development.

Although MAPS is focused on its anticipated FDA approval for MDMA therapy for PTSD, Doblin commented on the possibility of a NeuroDirect topical cream, which does not create a “psychedelic experience,” being useful as an adjunct treatment.

“Our approach to PTSD at MAPS are macrodoses of MDMA for three eight-hour sessions — large cathartic experiences for extended periods of time — embedded in a series of twelve 90 minute non-drug psychotherapy sessions for preparation and integration. I could see the possibility of NeuroDirect ketamine being helpful during the integration therapy, for example,” said Doblin.

Doblin also expressed his thoughts about how Psycheceutical’s topical cream delivery system could possibly be tested for use with MDMA or other compounds in the future.

“I’m curious to learn about the results of Psycheceutical’s upcoming clinical trials in Australia and to further evaluate this potential treatment. I look forward to reviewing more research data,” said Doblin. “Sometimes the biggest breakthroughs are right under our noses.”

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 a topical cream applied 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.

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, including the transferability to the US FDA of trial results from trials conducted outside of the US (vi) incorrect underlying assumptions, 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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/62f9ac91-21a3-4a1a-9417-38d18560471f

FAQ

What is the NeuroDirect™ ketamine topical cream developed by Psycheceutical?

The NeuroDirect™ ketamine topical cream is an innovative treatment for PTSD designed to deliver psychedelic compounds non-invasively, minimizing side effects.

What were the results of the pre-clinical studies for NeuroDirect™?

Pre-clinical studies indicated that 80% of patients experienced significant relief from PTSD symptoms without psychoactive effects.

When is Psycheceutical planning to start clinical trials for its ketamine cream?

Psycheceutical intends to begin clinical trials for the NeuroDirect ketamine topical cream in Q2 2023.

Who is Rick Doblin and what is his involvement with Psycheceutical?

Rick Doblin is the founder of MAPS and visited Psycheceutical's lab to learn about the NeuroDirect technology and its potential applications.

How does the NeuroDirect delivery system work?

The NeuroDirect delivery system administers psychedelic compounds topically at the back of the neck, allowing for immediate and sustained delivery without systemic side effects.