- PharmaTher Holdings (PHRM) has received FDA approval for the company’s Investigational Ketamine trial
- The FDA approval clears the way for PharmaTher to proceed with a Phase 2 clinical trial of Ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease
- PharmaTher expects to begin enrolling patients for the Phase 2 clinical trial in Q3-2021 and will meet with the FDA to discuss a Phase 3 clinical trial next year
- The company has assembled a prolific scientific and clinical team experienced in Parkinson’s disease
- PharmaTher is a psychedelics biotech company focused on the research, development and commercialization of Ketamine
- PharmaTher Holdings Ltd. (PHRM) is up 26.32 per cent, trading at C$0.24 per share at 9:50 am ET
The FDA has approved PharmaTher’s (PHRM) Investigational New Drug (IND) application to proceed with the Phase 2 clinical trial of Ketamine.
The FDA approval clears the way for PharmaTher to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of Ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease (“LID-PD”).
PharmaTher expects to begin enrolling patients for the Phase 2 clinical trial in Q3-2021. Assuming the Phase 2 clinical trial is positive, the company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study next year.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said,
“The FDA’s acceptance of our IND application for Ketamine to treat Parkinson’s disease is a significant milestone for us. The FDA IND is our first of many we will aim to obtain, and we are one of the few psychedelics-focused biotech companies that have an IND approved by the FDA for a recognized psychedelic drug. The IND paves the way for us to expeditiously evaluate Ketamine and other psychedelics via the FDA regulatory pathway in various mental illness, neurological and pain disorders. We are committed to building a rich product pipeline of novel uses, formulations and delivery methods of psychedelics, and with our FDA IND in place, we now have the foundation in making PharmaTher a global leader in psychedelic-based therapeutics.”
Parkinson’s disease is a debilitating disorder that affects over 1 million people in the U.S. and more than 7 million people worldwide. There is currently no cure for Parkinson’s disease, although some drug combinations are used to treat the disease symptoms. The global Parkinson’s disease market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 2025 and the potential market opportunity for LID-PD could exceed US$3 billion in the U.S. alone.
The Phase 2 clinical trial is titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease.” The primary end-point of the study is to document the change in the Unified Dyskinesia Rating Scale (“UDysRS”) total score from Baseline to Week 8.
Because LID can markedly affect a Parkinson patient’s everyday activities, a reduction in LID could improve the patient’s quality of life.
The company has assembled a prolific scientific and clinical team experienced in Parkinson’s disease, including Dr. Scott Sherman and Dr. Torsten Falk from the University of Arizona, Dr. Alberto Espay from the University of Cincinnati and Dr. Robert Hauser from the University of South Florida.
Ketamine is an FDA-approved N-methyl-D-aspartate (NMDA) receptor-modulating drug that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents. The possible therapeutic effect of low-dose Ketamine on LID was noted in a retrospective analysis of PD patients who received Ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment. Ketamine may also have additional benefits in the treatment of pain which are frequent comorbidities of Parkinson’s disease.
As a progressive neurogenerative disorder of the central nervous system that primarily affects the motor nerve system, symptoms of Parkinson’s disease may emerge slowly and include tremors, rigidity, bradykinesia, and postural instability. Patients may also experience non-motor symptoms such as autonomic dysfunction (orthostatic hypotension, constipation, bladder dysfunction), psychiatric (depression), cognitive and sensory symptoms (pain). These non-motor symptoms become more common as the disease progresses.
PharmaTher is a psychedelics biotech company focused on the research, development and commercialization of Ketamine and novel microneedle patches for the delivery of psychedelics to treat mental illness, neurological and pain disorders.
PharmaTher Holdings Ltd. (PHRM) is up 26.32 per cent, trading at C$0.24 per share at 9:50 am ET.
