Psychedelics could be a game-changer for millions dealing with depression, anxiety, addiction issues, PTSD, and even issues such as Parkinson’s disease. All of which is driving significant attention to companies like PharmaTher Holdings Ltd. (CSE: PHRM)(OTCQB: PHRRF), Mind Medicine Inc. (NEO:MMED)(OTC:MMEDF), Compass Pathways (NASDAQ:CMPS), Seelos Therapeutics Inc. (NASDAQ:SEEL), and Cybin Inc. (NEO:CYBN)(OTC:CLXPF).
With Parkinson’s, for example, about 10 million people struggle with it all over the world. Up to 60,000 people are diagnosed with it just in the U.S. every year. Worse, a Parkinson’s epidemic could be on the horizon, says Dr. Ray Dorsey, a neurologist at the University of Rochester Medical Center, as quoted by The Guardian. 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.
Luckily, there may be a solution for levodopa-induced dyskinesia in patients with Parkinson’s disease (LID-PD). In fact, PharmaTher just announced the successful completion of a Type B pre-Investigational New Drug meeting with the U.S. FDA regarding its proposed Phase 2 clinical study for ketamine in the treatment of LID-PD. Better, the US FDA already confirmed that a 505(b)(2) regulatory pathway is acceptable, which allows for the potential to accelerate the clinical development for drug approval.
PharmaTher Submits IND Application with US FDA to Evaluate Ketamine with Parkinson’s
PharmaTher Holdings Ltd. (CSE: PHRM)(OTCQB: PHRRF), announced it submitted an Investigational New Drug application (IND) with the U.S. FDA for the initiation of a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of low-dose ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.
“The submission of our IND application with the FDA is an important milestone as it provides us with a solid foundation to advance our ambition in commercializing ketamine and unlocking its therapeutic potential through novel uses, formulations and delivery methods in the treatment of neurodegenerative diseases (ie. Parkinson’s disease and Lou Gehrig’s disease), mental illness (ie. Depression and PTSD) and chronic pain,” said Fabio Chianelli, CEO of PharmaTher.
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.
The clinical trial is titled “A Multi-Center, Phase IIA, 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.
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 pivotal Phase 3 clinical study under the 505(b)(2) regulatory pathway. However, there can be no assurance that the FDA will support any potential request for an expedited path to approval or further development.
Other related developments from around the markets include:
Mind Medicine Inc., a leading clinical-stage psychedelic medicine biotech company, announced the publication of the first study on MDMA dosing optimization using personalized medicine. The study took place at the University Hospital Basel Liechti Lab, in Basel, Switzerland. This study provides the first scientific data for predicting responses to MDMA and optimizing dosing. This may maximize the potential beneficial therapeutic effects while reducing adverse responses when treating medical conditions. The study used data from 194 MDMA administrations in ten randomized placebo-controlled studies in healthy subjects conducted by the Liechti Lab at the University Hospital Basel, Switzerland.
Compass Pathways, a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, welcomed a study published in the New England Journal of Medicine (NEJM) yesterday, which showed signals of positive activity in COMP360 psilocybin compared with the standard antidepressant escitalopram, for major depressive disorder (MDD). The study was designed and conducted by a research team at Imperial College London, using COMPASS’s COMP360 psilocybin.
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 RBC Capital Markets Global Healthcare Conference, May 18-20, 2021. Raj Mehra, Ph.D., Chairman and CEO, will present on Tuesday, May 18th at 4:50pm ET and host 1x1 meetings on May 18th and 19th. For more information and to register for the webcast: 2021 RBC Capital Markets Global Healthcare Conference.
Cybin Inc. announced plans to advance the pre-clinical work for its orally dissolving tablet formulation of CYB003 and its inhaled formulation of CYB004, two of the Company’s deuterated tryptamine development candidates. These studies are part of the required U.S. Food and Drug Administration enabling trials for investigational new drug applications. Upon successful completion, the results of the IND-enabling studies will be included in the submissions to the FDA, as well as to other regulatory bodies, such as Health Canada and European Medical Association. The candidates would then advance into Phase 1 human clinical trials for specified psychiatric conditions. Labcorp Drug Development will serve as the pre-clinical research organization for Cybin.
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