December 10th, 2020
PharmaTher Inc., (“PharmaTher”), a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTC Pink: PHRRF) and a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that it has been granted a Pre-Investigational New Drug (“PIND”) meeting with the U.S. Food and Drug Administration (“FDA”) for the clinical development of ketamine in Parkinson’s disease and its proposed Phase 2 clinical study for ketamine in the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (“LID-PD”).
The Company requested a written response meeting with the FDA. The goal date for the FDA to provide written responses is January 31, 2021. The Company has substantially completed its Investigational New Drug (“IND”) application and it plans to file the IND application after receiving FDA responses to initiate a Phase 2 clinical study for ketamine in LID-PD in Q1-2021.
“We are pleased that our initiatives focused on the FDA regulatory pathway for ketamine continues its momentum and the IND builds a foundation where we can develop an FDA approved ketamine for not only Parkinson’s disease, but also for the millions of people worldwide affected by movement disorders, depression and pain,” said Fabio Chianelli, CEO of PharmaTher.
PharmaTher is progressing its patent portfolio of novel ketamine therapies for Parkinson’s disease and movement disorders, depression and pain via the FDA regulatory pathway. The pre-IND meeting responses will provide valuable information for the Company to pursue Phase 2 clinical studies in Parkinson’s disease and movement disorders.
Results from preclinical data and case studies in Parkinson’s disease patients 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. 1-5
Ketamine is an FDA-approved drug with a known safety profile. PharmaTher entered into an exclusive license agreement with the University of Arizona to develop and commercialize ketamine to treat Parkinson’s disease and movement disorders. The Company also has filed with the FDA to receive orphan drug designation for ketamine in the treatment of LID-PD.
The Company has assembled a prolific scientific and clinical team experienced in Parkinson’s disease and movement disorders, 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.
About Parkinson’s Disease
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 6 and it is estimated that the potential market opportunity for LID-PD to be over USD $3 billion in the U.S. alone.
About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTC Pink: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals. PharmaTher repurposes psychedelic pharmaceuticals, such as FDA-approved ketamine and psilocybin, for FDA approval to treat neurological disorders, such as Parkinson’s disease and movement disorders, depression and pain.
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