PharmaTher Files The Psilocybin Psychedelic Combinations Therapies Patent With The FDA

PharmaTher is a specialty life science company focused on the research and development of psychedelics. They have recently filed patents with the FDA to mix FDA approved neurological drugs with Ketamine, Psilocybin, Cannabis, and MDMA to treat neurological disorders using GelMA micro-needle technology and transdermal patches.

The company recently partnered with third-party research institution and life sciences company, Terasaki Institute, to collaborate on the research and development of psychedelics in combination with certain FDA approved drugs to treat neurological disorders with the goal to create entirely new drugs. The patents are filed under the title, The Psilocybin Pharmaceutical Combination Therapies. PharmaTher CEO Fabio Chianelli releases a statement, “We are excited to work with the Terasaki Institute and the inventors of the GelMA delivery technology as it enables a solid foundation to expedite the product and clinical development for a first-of-a-kind micro-dosing delivery system for psilocybin, MDMA, LSD and DMT to treat serious unmet medical needs,  The FDA approval pathway is the foundation of our business to protect our development and commercialization of objectives and to increase shareholder value for the long-term". The goal is to then receive an investigational new drug approval with the FDA. PharmaTher in collaborations with the Terasaki Institute, aims to develop a novel micro-needle patch that aims to deliver psychedelic pharmaceuticals such as psilocybin, MDMA, lysergic acid diethylamide (LSD) and DMT through micro-dosing. PharmaTher will focus on developing a micro-needle patch for microdosing psychedelics that may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems. The product and clinical development plan will seek to obtain FDA approval in delivering various psychedelics for various mental health, neurological and pain disorders. The GelMA micro-needle delivery technology has demonstrated to deliver water-soluble and insoluble drugs with desirable release profiles. GelMA is derived from the natural polymer gelatin with crosslinkable methacrylate, making it an ideal candidate for micro-needle fabrication. GelMA was invented and developed by the members of the Khademhosseini Lab at the University of California, Los Angeles (“UCLA”), and the Terasaki Institute continues to utilize and expand upon its capabilities. Mixing pharmaceuticals already approved for neurological disorders with psychedelics could be an issue and cause side effects including serotonin syndrome. Patient Pre-screening and checking for possible drug interactions is vital, especially when combining psychedelics with Neurological pharmaceuticals known as SSRIs or Selective Serotonin Re-uptake Inhibitors. Reports from uneducated patients are showing tremendous complications when combining psychedelics with SSRIs. Ayahuasca is a very useful therapeutic medicine, but newcomers have to detoxify and cleanse the body before the ceremony due to the purge associated with this sacred brew, including stopping all pharmaceuticals weeks or months before your “Trip”. The company uses PanaceaAI to discover combinations of psilocybin and FDA approved drugs. PanaceaAI is a proprietary drug re-purpose platform they use to discover new uses of psychedelics in combination with already approved FDA drugs to improve efficiency and eliminate side effects. Using Artificial Intelligence is the future of customized compounded pharmaceuticals. PharmaTher is taking this technology one step further, bringing old and unused drugs back to life with a little touch of psychedelia this time around. Newscope Capital Corporation, who through its wholly-owned subsidiary, PharmaTher Inc, is pleased to announce that, further to its press release dated December 21, 2020, it has entered into an asset purchase agreement with Revive Therapeutics Ltd. to sell the full rights to PharmaTher’s intellectual property pertaining to psilocybin.

Pursuant to the Agreement, Revive will pay aggregate consideration of up to CAD $10 million. The Purchase Price will be satisfied as follows: (i) $3 million in cash will be paid on the closing date; (ii) $4 million will be satisfied through the issuance of securities in the capital of Revive and (iii) up to $3 million, in either cash or securities in the capital of Revive, in the event that Revive achieves certain milestones, which include Revive obtaining FDA orphan drug designation for psilocybin in the treatment of stroke, traumatic brain injury, or cancer, the commencement of a Phase 2 clinical trial and the regulatory filing for market authorization, such as U.S. Food and Drug Administration approval. In addition to the Purchase Price, Revive will also pay Newscope Capital Corporation a low single digit royalty on all future net sales of products derived from the Acquired Assets.

“We are very pleased with the sale of our psilocybin program as it pertains to the intellectual property and research for the use of psilocybin in the treatment of stroke, traumatic brain injury and cancer to Revive as it provides us with non-dilutive funding to advance the clinical development of ketamine in the treatment of Parkinson’s disease, KETABET™ in the treatment of depression and the development of our proprietary microneedle delivery technologies to deliver psychedelic pharmaceuticals including ketamine, esketamine, psilocybin, MDMA, LSD and DMT for various mental health, neurological and pain disorders,” said Fabio Chianelli, CEO of PharmaTher. “We are now in a strong position to unlock the value of our unique psychedelic-based product pipeline and microneedle delivery technologies, and to advance our lead program ketamine to treat Parkinson’s disease towards FDA Phase 2 clinical trials.”

“We are pleased with our purchase of PharmaTher’s psilocybin portfolio as it complements Revive’s current psilocybin-based programs in oral thin film delivery, a clinical study for a drug abuse disorder and the development of a biosynthetic version of psilocybin,” said Michael Frank, CEO of Revive. “Revive is positioned to advance its unique prescription-based psilocybin program for future clinical development with the objective in commercializing its product offerings through the FDA approval pathway.”

The Acquired Assets will include all of the following:

All intellectual and work property derived from pre-clinical research activities from the National Health Research Institutes in traumatic brain injury and stroke, as it relates to psilocybin with the aim to obtain FDA Orphan Drug Designation.

Key provisional patent applications with the U.S. Patent and Trademark Office, which include:

(i) Psilocybin in the Treatment of Neurological Brain Injury - United States Provisional Application Serial No. 63/011,493 – Relates to pharmaceutical compositions comprising psilocybin and their use for the treatment of neurological brain injuries and migraines.

(ii) Use of Psilocybin in the Treatment of Cancer, United States Provisional Application Serial No. 63/113,913 – Psilocybin’s use of significant unmet medical needs for Liver Carcinoma, Melanoma, Breast Neoplasms, Kidney Neoplasms and Acute Myeloid Leukemia.

(iii) Psilocybin Pharmaceutical Combination Therapies, United States Provisional Application Serial No. 63/125,106 – Novel combinations of certain FDA approved drugs with psilocybin as a potential therapeutic option to reduce the side effects and improve the effectiveness of psilocybin to treat neurological disorders.

The Company cautions that psilocybin is still under early-stage research and development and is not making any express or implied claims as to their success alone and in combination of FDA approved drugs or commercial viability. 

Resources: http://www.globenewswire.com/news-release/2021/02/17/2177225/0/en/PharmaTher-Announces-Sale-of-Psilocybin-Program.html