- PharmaTher is researching therapeutic applications of psychedelics to treat mental health, neurological, and pain disorders.
- The company has partnered with the Queen’s University of Belfast for the development of a hydrogel-forming microneedle to deliver ketamine.
- Through sponsored research partnerships, PharmaTher is also pursuing ketamine-based treatment options for Parkinson’s disease and amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.
Canadian biotechnology company PharmaTher is focused on the research and development of psychedelic pharmaceuticals, specifically ketamine, for a variety of unmet mental health, neurological, and pain disorders such as major depressive disorder, suicidal ideation, bipolar, post-traumatic stress disorder, Parkinson’s disease, and amyotrophic lateral sclerosis (ALS). Here is what the company has been up to in 2021 so far.
Microneedle Delivery of Ketamine
In February, PharmaTher announced it has entered into a worldwide exclusive patent and know-how license agreement with Queen’s University of Belfast Chair of Pharmaceutical Technology Professor Ryan Donnelly to develop and commercialize hydrogel-forming microneedle delivery technology. On March 24, the company also announced it had entered into a sponsored research agreement with the university to develop this technology. PharmaTher’s patented formulation, KETABET, which combines Food and Drug Administration (FDA) approved ketamine with betaine, will be incorporated with Professor Donnelly’s microneedle patch technology.
A June 2020 research paper by Professor Donnelly’s team states that the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format. Professor Donnelly said in a statement: “our recent research with esketamine in our patented microneedle technology shows the potential of an alternative delivery method that can overcome the limitations of current ketamine delivery options without compromising the safety and compliance of patients.”
“PharmaTher’s KETABET microneedle patch aims to empower patients to dose their medication remotely, safely, and conveniently rather than being under supervision by a healthcare provider at a certified medical office,” PharmaTher added. “The KETABET microneedle patch has the potential for enabling continuous delivery of KETABET, without pain, with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours that will improve efficacy and compliance for patients.”
“Also, PharmaTher’s KETABET microneedle patch will incorporate anti-tampering and anti-abuse features because of the combined presence of ketamine and betaine, and the delivery format of the product that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.”
PharmaTher CEO Fabio Chianelli said that the microneedle patch could change the way mental health, neurological, and pain disorders were treated. “We are pursuing the clinical development of the KETABET microneedle patch to overcome the current limitations of ketamine and to unlock the known potential therapeutic value of ketamine as a prescription for regulatory approval worldwide,” he said.
PharmaTher is also developing a novel microneedle patch that aims to deliver psychedelics such as psilocybin, MDMA, LSD, and DMT through a sponsored research agreement with non-profit research group the Terasaki Institute for Biomedical Innovation. Announced in late February, this partnership is also focused on microdosing psychedelics to overcome potential drawbacks of oral administration, subcutaneous injections, topical, and nasal delivery systems.
Proposed Phase 2 Clinical Study on Ketamine and Parkinson’s Disease
PharmaTher successfully completed a Type-B pre-Investigational New Drug (pre-IND) meeting with the FDA in February about its proposed Phase 2 clinical study for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease. In a statement, the company said it would proceed to file an IND application in Q1 2021 with the aim of starting the clinical study in Q2.
“We were very pleased with the outcome of our pre-IND meeting with the FDA as it provided positive guidance to support our clinical development program for ketamine to treat Parkinson’s disease patients while also outlining the various safety and efficacy endpoints to be used in the Phase 2 study to support a potential Phase 3 clinical study in the future,” Chianelli said.
PharmaTher has also entered into an exclusive license agreement with the University of Arizona to develop and commercialize ketamine to treat Parkinson’s disease and movement disorders. “Study results from preclinical studies and case studies in Parkinson’s disease patients from the University of Arizona have shown that low-dose sub-anesthetic ketamine infusion indicates tolerability, safety, and the potential of long-term therapeutic benefit to reduce levodopa-induced dyskinesia, improve on time, and reduce depression,” the company said.
Partnership to Research Ketamine and ALS (Lou Gehrig’s disease)
Through an exclusive license agreement with the University of Kansas, PharmaTher will be researching the use of ketamine in the treatment of ALS, also known as Lou Gehrig’s disease. Announcing the agreement in March, PharmaTher said in a statement: “ketamine has the potential to effectively increase the life expectancy of those with ALS at any stage and slow the progressive loss of muscle associated with poor outcomes of the disease.”
“Ketamine works by blocking the action of the ionotropic glutamate receptor, the NMDA receptor. Unlike other inhibitors of NMDA receptor function, such as riluzole, ketamine dampens NMDA receptor-related glutamate excitotoxicity indirectly. Further, ketamine can lower D-serine concentrations intracellularly and also partially activates dopamine receptors. Collectively, these mechanisms of ketamine contribute in part to the drug’s neuroprotective effects which may extend to the motor neurons targeted in ALS.”
The company plans to seek FDA approval for Orphan Drug Designation of ketamine in the treatment of ALS and is working towards an FDA investigational new drug application in order to conduct a Phase 2 clinical study later this year.
Sale of Psilocybin Program to Revive Therapeutics
As announced in late 2020, PharmaTher has sold the rights to all of its intellectual property related to psilocybin, including key patents, to Revive Therapeutics. This includes:
- all intellectual and work property derived from PharmaTher’s pre-clinical research activities in traumatic brain injury and stroke, with the aim to obtain U.S. Food and Drug Administration (FDA) Orphan Drug Designation;
- all intellectual property portfolio covering neurological disorders, cancers, and novel combinations of psilocybin and FDA approved drugs;
- all intellectual and work property derived from the study being currently undertaken by the National Health Research Institute in Taiwan; and,
- key provisional patent applications with the US Patent and Trademark Office.
Key patents that would be purchased by Revive Therapeutics include:
- Psilocybin in the Treatment of Neurological Brain Injury, US Provisional Application Serial No. 63/011,493 which relates to pharmaceutical compositions comprising psilocybin and their use for the treatment of neurological brain injuries and migraines;
- Use of Psilocybin in the Treatment of Cancer, US Provisional Application Serial No. 63/113,913 which relates to Psilocybin’s use of significant unmet medical needs for Liver Carcinoma, Melanoma, Breast Neoplasms, Kidney Neoplasms, and Acute Myeloid Leukemia; and,
- Psilocybin Pharmaceutical Combination Therapies, US Provisional Application Serial No. 63/125,106 which relates to 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 sale comes after the two companies last year entered into a research partnership to explore psilocybin’s potential to treat certain cancers such as liver carcinoma, melanoma, breast neoplasms, kidney neoplasms, and acute myeloid leukemia. Following the sale, PharmaTher instead plans to dedicate its resources to its ketamine research.
PharmaTher confirmed in a press release on February 17 that the company’s psilocybin program would be purchased by Revive Therapeutics for an aggregate consideration of up to $10 million CAD.