Nearly 10 million people struggle with Parkinson’s disease at the moment.While there is no cure for Parkinson’s disease just yet, treatments such as L-dopa, or Levodopa can help control the symptoms, including stiffness, weakness, and rigidity. Unfortunately, even long-term exposure to L-dopa can cause issues, such as dyskinesia, which can include rapid, involuntary, and uncontrollable movements. However, there may be a solution for levodopa-induced dyskinesia in patients with Parkinson’s disease (LID-PD). In fact, PharmaTher (CSE:PHRM) (OTC:PHRRF) just announced that the U.S. FDA just approved the Company’s Investigational New Drug application 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.
Success could also open the door for other psychedelic companies, too, including Mind Medicine Inc. (NEO:MMED)(NASDAQ:MNMD), Compass Pathways (NASDAQ:CMPS), Seelos Therapeutics Inc. (NASDAQ:SEEL), and Cybin Inc. (NEO:CYBN)(OTC:CLXPF).
PharmaTher Announced FDA Approval of Ketamine IND in Treatment of Parkinson’s Disease
PharmaTher Holdings Ltd. (CSE: PHRM)(OTCQB: PHRRF) a psychedelics biotech company, is pleased to announce that the U.S. Food and Drug Administration has approved the Company’s Investigational New Drug application 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. PharmaTher expects to begin enrolling patients in 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 under the 505(b)(2) regulatory pathway 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 [360iResearch 2020] and it is estimated that the potential market opportunity for LID-PD to be over USD $3 billion in the U.S. alone.
About the Phase 2 Clinical Trial
The 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.” It is anticipated that up to eight clinical sites in the U.S. will randomize a total of up to 36 subjects to the investigational product (ketamine) or active control (midazolam). The primary end-point of the study is the change in the Unified Dyskinesia Rating Scale total score from Baseline to Week 8. Secondary endpoints of the study include the change in Total Objective Scores of the UDysRS, total daily OFF times as assessed by subject-completed 24-hour diaries and change in the UPDRS total and sum scores of motor and dyskinesia 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’s Potential In Parkinson’s Disease
Ketamine is an FDA-approved N-methyl-D-aspartate receptor-modulating drug that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents [Smith et al, 1987; Pacheco et al, 2014]. 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 [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016]. Ketamine may also have additional benefits in the treatment of pain [Niesters et al, 2014] and depression [Diamond et al, 2014; Murrough et al, 2013], which are frequent comorbidities of Parkinson’s disease.
Other related developments from around the markets include:
Mind Medicine Inc. announced that it has appointed Dr. Sarah Y. Vinson as a director of the Company and a member of its audit committee, effective immediately. Dr. Vinson is a Triple Board-Certified physician who specializes in adult, child & adolescent, and forensic psychiatry. She is the founder of Lorio Forensics, a multidisciplinary mental health expert consultation firm and of the Lorio Psych Group, a group mental healthcare practice. Dr. Vinson is an Associate Clinical Professor of Psychiatry and Pediatrics at Morehouse School of Medicine, where she is the Program Director of the Child & Adolescent Psychiatry Fellowship, and Adjunct Faculty at Emory University School of Medicine. Just two years after joining the faculty at Morehouse School of Medicine she was honored as Psychiatry and Faculty of the Year in 2015. Throughout her career, Dr. Vinson has provided clinical care to children, adolescents, and adults in both publicly funded and private treatment settings.
Compass Pathways, a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, reported its financial results for the first quarter 2021 and gave an update on recent progress across its business. George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “Our recent financing gives us additional resources to work even faster and to expand our efforts, grow our team, and focus on developing new indications, new compounds and new technologies, building on our leadership position in psilocybin therapy and mental health care. Far too many people are suffering with mental health challenges today. We are focused on developing evidence-based therapies that can make a difference and be accessible to as many patients as possible who might benefit. The COMP360 data published in the New England Journal of Medicine showed promising signals in a small investigator-initiated study. We are approaching the completion of our phase IIb trial of COMP360 psilocybin therapy for treatment-resistant depression, and on track to report data by the end of the year.”
Seelos Therapeutics Inc., a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced that it will participate in the 2021 Jefferies Virtual Healthcare Conference, June 1-4, 2021. Raj Mehra, Ph.D., Chairman and CEO, will present on Thursday, June 3rd at 10:30am ET and host 1x1 meetings.
Cybin Inc., a biotechnology company focused on progressing psychedelic therapeutics, announced that it has selected Alcohol Use Disorder as the initial target indication for its proprietary deuterated psychedelic tryptamine, CYB003. AUD is a chronic relapsing brain disorder characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. Approximately 5.8 percent or 14.4 million adults in the United States ages 18 and older had AUD in 2018. This includes 9.2 million men and 5.3 million women. To be diagnosed with AUD, individuals must meet certain criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders. Under DSM–5, the current version of the DSM, anyone meeting any two of the 11 criteria during the same 12-month period receives a diagnosis of AUD. The severity of AUD—mild, moderate, or severe—is based on the number of criteria met.
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